Volume 36, Issue 3 , Pages 235-246, September 2008
A Randomized Controlled Trial Testing the Efficacy of an HIV/AIDS Symptom Management Manual
Article Outline
Abstract
This study investigates whether using an HIV/AIDS symptom management manual with self-care strategies for 21 common symptoms, compared to a basic nutrition manual, had an effect on reducing symptom frequency and intensity. A 775-person, repeated measures, randomized controlled trial was conducted over three months in 12 sites from the United States, Puerto Rico, and Africa to assess the relationship between symptom intensity with predictors for differences in initial symptom status and change over time. A mixed model growth analysis showed a significantly greater decline in symptom frequency and intensity for the group using the symptom management manual (intervention) compared to those using the nutrition manual (control) (t
=2.36, P=0.018). The models identified three significant predictors for increased initial symptom intensities and in intensity change over time: (1) protease inhibitor-based therapy (increased mean intensity by 28%); (2) having comorbid illness (nearly twice the mean intensity); and (3) being Hispanic receiving care in the United States (increased the mean intensity by 2.5 times). In addition, the symptom manual showed a significantly higher helpfulness rating and was used more often compared to the nutrition manual. The reduction in symptom intensity scores provides evidence of the need for palliation of symptoms in individuals with HIV/AIDS, as well as symptoms and treatment side effects associated with other illnesses. The information from this study may help health care providers become more aware of self-management strategies that are useful to persons with HIV/AIDS and help them to assist patients in making informed choices.
Key Words: HIV/AIDS, symptom management, randomized controlled trial, linear mixed-effects growth models
Introduction
HIV disease and antiretroviral (ARV) therapy are accompanied by intense physical and psychological symptoms that require focused assessment, interventions, and ongoing management. People living with HIV/AIDS symptoms frequently seek information and care from their providers with the onset of symptoms and side effects. Studies suggest that intense symptoms can reduce adherence to medications and affect quality of life for people living with HIV/AIDS.1, 2, 3, 4, 5 Drug therapy and other suggestions by health care providers may or may not effectively reduce symptom intensity. Often patients begin searching for self-care solutions to ameliorate the frequency and intensity of their symptoms. This study tested the efficacy of a self-care symptom management manual by examining whether patients who used the manual demonstrated an improvement in the self-report of symptom frequency and symptom intensity of frequently occurring symptoms.
Due to the effectiveness of current therapies, HIV/AIDS has evolved in adequately resourced areas from an acute illness to a chronic illness, but with frequent symptom exacerbation. Like other chronic diseases, the nature of HIV/AIDS disease progression affects both the physiological and psychological aspects of health. In patients with untreated HIV infection, the incapacitation of T-cell immunity allows the HIV virus to spread and permits opportunistic infections to occur, affecting the functions of multiple organ systems. In treated patients, the use of triple ARV therapies may challenge patients and providers with a series of distressing side effects that can be difficult to control, including lipodystrophy, insulin resistance, neuropathy and cardiovascular effects. Additionally, the unpredictable course of mixing sudden exacerbation and long periods of relative wellness introduces psychological distress, potentially triggering onsets of depressive symptoms and anxiety.6
The many physiological, psychological, and cognitive symptoms experienced by patients with HIV/AIDS, such as pain, diarrhea, fever, fatigue, depression, and confusion, have been found to restrict a person's daily life significantly. Self-management of multiple HIV-related symptoms and medication side effects, and maintaining optimal quality of life, have, therefore, become major daily tasks for people living with HIV/AIDS.7, 8, 9, 10 Patients vary in their approaches to these tasks. For example, Kemppainen and colleagues11 reported that the symptom management strategies for anxiety varied by race/ethnicity and also across cultures, and Coleman and colleagues12 reported ethnic differences in the use of prayer as a self-care strategy for anxiety, fatigue, and depression.
The lack of a simple handbook on how to reduce symptoms led researchers at the University of California School of Nursing to develop a manual entitled The HIV/AIDS Symptom Management Manual in 2004. The manual was validated by HIV-expert clinicians and corroborated by scientific evidence on 21 commonly occurring HIV-related symptoms. For each symptom, the information is divided into three sections: (1) Problem section (a brief description of the symptom); (2) Treatment section (ways that the symptom is commonly treated, successful alternative strategies, and the importance of professional consultation as part of a treatment plan); and (3) Self-Care section (multiple identified self-care strategies that may be useful to decrease and/or resolve the symptom). The manual is available in English (with African terms) and in English (without African terms). In addition, the manual has been translated into Afrikaans, Sesotho (from Lesotho), Siswati (from Swaziland), Zulu (from South Africa), Spanish (from Puerto Rico), and Russian. It is freely available for download at http://www.UCSF/Aidsnursing.org.
Methods
The Committee on the Protection of Human Subjects at the University of California, San Francisco, reviewed and accepted the protocol. Each site also received approval from their appropriate human subjects review committee. As this was a behavioral intervention, a Data Safety & Monitoring Board was established by the University of California, San Francisco HIV Center to monitor the performance and safety of the clinical trial.
Sample and Study Design
HIV-positive participants were recruited from clinics and HIV-focused community settings in Africa, Puerto Rico, and from 10 sites across the United States. All individuals had access to ARV medications if needed. The surveys and manuals were given either in English or Spanish. Spanish versions of the surveys and manuals were developed by using a translation and back-translation methodology to assure consistent terminology for use in Puerto Rico and in the Southern United States. The survey and manuals were administered in English to participants from the South African sites. A randomized controlled trial with a two-group repeated measures design was used to test the efficacy and helpfulness of the self-care symptom management manual compared to a general nutrition based manual. The control group was given a general nutrition booklet of similar size and at the eighth grade reading level, measured by the Flesch–Kincaid index, as a mechanism to address concerns of attention control in that group. The nutrition manual was modified from the World Health Organization HIV/AIDS Nutrition Guide,13 which is an informational guide on food groups and nutrition needs. The guide is focused on the importance of adequate nutrition in HIV-infected individuals in the maintenance of health and quality of life.
Exclusion criteria for participation in the study included: (1) a documented diagnosis of dementia; (2) unable to understand consent procedure as judged by the person getting consent; (3) reporting no symptoms within the past week; and (4) report of having had experience with a self-care manual.
The two groups (intervention and control) were assessed in a repeated measures design at three time points: baseline (time 0), one-month follow-up (four to six weeks), and two-month follow-up (seven to 12 weeks). Data were collected between December 2005 and January 2007 from a convenience sample of 775 subjects with HIV/AIDS who were randomized at baseline to participate in a comprehensive assessment survey. The participants were randomized to receive either intervention (n=426, 55% of the total sample) or control (n=349, 45% of the total sample) groups. Six hundred five participants (intervention=339, 56%; control=266, 44%) returned for the one-month follow-up assessment and 506 participants (intervention=275, 54%; control=231, 46%) returned for the two-month follow-up assessment. The combined intervention and control attrition rate for the three-month study duration was 34.6%. There were no significant differences in the attrition rates between the intervention and control groups (Fig. 1).
Fig. 1
Participant loss by experimental and control groups over time.
The participants completed self-report assessment surveys that included questions about demographic and illness background, and asked if they experienced any symptoms from a list of 64 symptoms within the last 24hours. Participants who were unable to complete the survey on their own were read the survey; this occurred in only eight cases. At the one- and two-month follow-up periods, participants were asked to rate the symptom management and nutrition manuals for usefulness, and number of times the manuals were accessed over the last week and last month. Following completion of the final survey assessment, the participant was given the manual that they did not receive at the time of randomization; therefore, both groups received both the symptom and nutrition manuals.
Instruments
Three instruments were used in this study including a demographic questionnaire, the Revised Sign and Symptom Checklist for Persons with HIV Disease, and a manual helpfulness questionnaire assessing either the nutrition guide or the self-care symptom management manual.
Analytical Methods
Responses to the questionnaires were entered into Statistical Package for the Social Sciences for Windows Version 14.0 software (SPSS, 2004).14 Descriptive statistics (i.e., means, standard deviations, frequencies, and percents) were used to examine demographic characteristics of the sample and the frequency and intensity of the symptoms.
Multilevel growth mixture modeling is an iterative statistical model development methodology that is particularly well suited to analyze symptom data. The method does not require equal waves of data as in repeated measures analysis of variance, making it attractive for longitudinal analyses, where participant attrition is so often a problem, as participants often drop out and return for later follow-up or dropout entirely. It is, therefore, useful in retaining power in statistical analyses.15 An assumption for using mixed modeling methods is that the cases missing to subsequent follow-up assessments are missing at random. It is assumed that there is correlation between the reports of symptoms as these reports are measured from the same subject repeatedly over time. To account for this correlation, repeated measures statistical analysis tools may be used to make inferences.16
Results
Sample
The average age for the sample participants (n=768) was 42.8 years (SD=9.6); 38.5% (n=296) were female. The participants were 28.1% African American, 21.2% Caucasian, 16.4% Hispanic American, 15.5% Africans from Africa, 11.5% Hispanic (Puerto Rican), 1.4% Asian, and 4.8% self-described as “Other.” Educational background included 41.5% who had a high school education, 29.1% who had a grade school level education, and 29.4% who had college or post-high school education. Sixty-two percent (n=228) reported having at least one child living with them. The HIV illness characteristics show the mean years living with HIV to be 9.1years (SD=6.6), 42% (n=322) had an AIDS diagnosis, 62.7% (n=470) reported a co-morbid illness and 70.4% (n=547) were presently taking ARV medications, with the mean number of years taking ARVs being 6.7 years (SD=5.2). One-third of the participants (n=251) reported that they knew their viral load was undetectable and 146 participants knew their detectable viral load value (mean=50,368, SD=135,000) (Table 1).
Table 1. Sample Demographic Data
| n | % | |
|---|---|---|
| Gender | ||
| Male | 455 | 59.2 |
| Female | 296 | 38.5 |
| Transgender | 17 | 2.2 |
| Age, mean±SD (range) | 42.8 yrs±9.6 yrs (20–72) | |
| Race | ||
| Asian/Pacific Islander | 11 | 1.4 |
| African National and American/Black | 335 | 43.6 |
| Hispanic/Latino | 214 | 27.8 |
| Native American Indian | 8 | 1.0 |
| White/Anglo (nonHispanic) | 163 | 21.2 |
| Other | 37 | 4.8 |
| Highest education | ||
| Grade school | 223 | 29.1 |
| High school | 318 | 41.5 |
| Technical/vocational school | 143 | 18.6 |
| College | 59 | 7.7 |
| Master's | 20 | 2.6 |
| Doctorate | 4 | 0.5 |
| Number of children at home | ||
| 0 | 139 | 37.9 |
| 1 | 81 | 22.1 |
| 2 | 80 | 21.8 |
| 3 | 31 | 8.4 |
| >4 | 36 | 9.8 |
| Data collection sites | ||
| USA (10) | ||
| California (3) | 107 | 13.8 |
| Texas (3) | 190 | 24.5 |
| Massachusetts (1) | 69 | 9.0 |
| Utah (1) | 69 | 9.0 |
| Illinois (1) | 16 | 2.0 |
| Pennsylvania (1) | 107 | 13.8 |
| Africa (2) | ||
| South Africa (1) | 48 | 6.2 |
| Kenya (1) | 71 | 9.2 |
| Puerto Rico (2) | ||
| San Juan (1) | 70 | 9.0 |
| Vega Baja (1) | 28 | 3.6 |
| AIDS diagnosis | ||
| Yes | 322 | 42.0 |
| No | 408 | 53.2 |
| Don't know | 37 | 4.8 |
| Taking HIV meds now | ||
| Yes | 537 | 70.4 |
| No | 226 | 29.6 |
| Other medical conditions | ||
| Yes | 470 | 62.7 |
| No | 280 | 37.3 |
| Years HIV Positive, mean±SD (range) | 9.1 yrs ±6.6 yrs (0–26) | |
| Recent CD4 count (if known), mean±SD (range) | 407±268 (0–1,200) | |
| Viral load “undetectable” | 251 | 33.4 |
| Viral load (greater than 50 copies/ml) (n=146), mean±SD (range) | 50,368±135,000 (50–750,000) | |
| Years on ARV medications, mean±SD (range) | 6.7 years ±5.2 years (0–20) | |
Ethnicity and Symptom Variation
Comparative analyses of the mean total symptom intensities (total possible score=192) of individuals reporting Hispanic ethnicity from Puerto Rico compared to Hispanic ethnicity in the United States showed the means to be significantly higher in the U.S. participants at the baseline (MUSA=55.0, MPR=42.7, t=2.33, P=0.02) and time one assessment periods (MUSA=47.6, MPR=31.6, t=2.90, P=0.004), but not significantly different at month two (MUSA=35.7, MPR=27.4, t=1.75, P=0.08). Both groups showed a similar and consistent reduction in the mean symptom frequency and intensity over time. Those individuals reporting African-American ethnicity were compared to those who identified themselves as African from the African study sites. The mean symptom frequency and intensity scores for the participants in Africa were also significantly lower for the baseline time period (MUSA=43.7, MAfrica=10.0, t=12.0, P≤0.001), with similar significant differences in the two subsequent assessment periods compared to the mean symptom intensity and frequency score for those participants who identified themselves as African American from the non-African sites.
Symptom Frequency
At baseline, the most frequently reported symptoms included both physical and psychosocial symptoms. Fatigue, depression, and muscle aches, general weakness, thirst, worry, difficult concentration, memory loss, dry mouth and insomnia were the most frequently reported symptoms. Similar results were noted for the one and two-month follow-up assessments. Table 2 shows the ranking of these frequently reported symptoms with a frequency range of 37% to 67% of the sample.
Table 2. Ten Most Frequently Reported Symptoms (Percentage of Participants Reporting Each Symptom)
| Symptom | Frequency | n |
|---|---|---|
| Fatigue | 57 | 446 |
| Depression | 56 | 432 |
| Muscle aches | 55 | 425 |
| Weakness | 53 | 408 |
| Thirst | 52 | 389 |
| Worry | 50 | 388 |
| Difficult concentration | 51 | 392 |
| Memory loss | 49 | 376 |
| Dry mouth | 50 | 387 |
| Insomnia | 48 | 371 |
ARV-Related Symptoms
A comparative review of symptom occurrence in individuals who were or were not taking ARVs was done to assess the report of unique symptoms associated with treatment (Table 3). The symptom reports of loose stools, diarrhea, shortness of breath with activity, weight gain in the stomach area, hump on back of the neck, skinny arms/legs, and prominent leg veins all showed higher than expected reports of mild, moderate, and severe symptom intensity for individuals taking ARVs. The symptom reports of thirst and insomnia showed higher than expected reports of moderate and severe symptom intensity for individuals taking ARVs. The symptom of numbness/tingling in arms showed higher than expected reports of mild and severe intensity and also was higher than expected in individuals not taking ARVs.
Table 3. Symptom Frequencies Showing Significant Differences in Individuals Taking ARVs
| Symptom | Taking ARVs Yes/No | PI-Based Regimen | NNRTI-Based Regimen | ||||||
|---|---|---|---|---|---|---|---|---|---|
| χ2 | df | P | χ2 | df | P | χ2 | df | P | |
| Loose stools | 11.59 | 3 | 0.009 | ||||||
| Diarrhea | 10.41 | 3 | 0.015 | ||||||
| SOB with activity | 7.10 | 3 | 0.050 | ||||||
| Weight gain—stomach area | 17.98 | 3 | ≤ .001 | 7.78 | 1 | 0.005 | |||
| Hump on back of the neck | 10.23 | 3 | 0.017 | 5.30 | 1 | 0.021 | |||
| Skinny arms/legs | 19.60 | 3 | ≤ .001 | 6.91 | 1 | 0.009 | |||
| Prominent leg veins | 11.99 | 3 | 0.007 | 8.34 | 1 | 0.004 | 7.89 | 1 | 0.005 |
| Thirst | 8.48 | 3 | 0.037 | ||||||
| Insomnia | 13.31 | 3 | 0.004 | ||||||
| Numbness/tingling in arms | 8.19 | 3 | 0.042 | 4.19 | 1 | 0.041 | |||
| Numbness/tingling in legs | 4.62 | 1 | 0.032 | ||||||
| Numbness/tingling in feet/toes | 4.21 | 1 | 0.040 | ||||||
| Gas/bloating | 6.91 | 1 | 0.009 | ||||||
A further analysis of symptom occurrence and intensity by ARV class (protease inhibitor [PI] and non-nucleoside reverse transcriptase inhibitors [NNRTIs]) was done for those individuals taking ARV therapy. Those individuals taking a PI-based treatment regimen reported higher than expected symptoms related to body change of weight gain in the stomach area, hump on back of the neck, skinny arms/legs, and prominent leg veins, as well as the gastrointestinal (GI)-related problem of gas/bloating. In individuals taking an NNRTI-based regimen, the symptom of prominent leg veins was also significantly higher.
Manual Helpfulness
For both the intervention and control groups, individuals who rated the manuals very helpful (scores of three or four) at one-and two-month follow-up assessments were significantly more likely to have lower symptom intensity scores, and scores that decreased at a higher rate over time, compared to those who rated the manuals with scores of one or two (t=2.57, P=0.01).
Manual Utilization Assessment
Comparison of the usefulness and the utilization rating of both the symptom management and nutrition manuals revealed a significantly higher usefulness rating for the symptom management manual for both the one-month follow-up assessment (t=3.27, P≤0.001), and for the two-month follow-up assessment (t=3.15, P=0.002). The report of use of the manuals on a weekly basis revealed that on average, the symptom management manual was used significantly more frequently than was the nutrition manual at the one-month follow-up assessment (t=3.13, P=0.002) and was again used more often at the two-month follow-up assessment (t=3.18, P≤0.002). The average monthly utilization comparison of the manuals showed no statistical difference for the first follow-up; however, on average, the symptom management manual was accessed significantly more frequently in month two (t=2.86, P≤0.005) (Table 4). At one month, males used the symptom management manuals more than did females (t=2.31, P=0.02), but there was no difference by gender for the two-month assessment.
Table 4. Symptom Intensity and Manual Usefulness Over Time
| Baseline (Time 0); Mean (SD) | Time 1; Mean (SD) | Time 2; Mean (SD) | ||
|---|---|---|---|---|
| SSC-HIVrev All groups—Total symptom intensity score (64 symptoms) | 39.6 (36.1) | 33.8 (33.8) | 28.2 (29.9) | |
| SSC-HIVrev All groups—Total symptom frequency score (64 symptoms) | 20.5 (19.6) | 18.2 (18.4) | 14.7 (15.8) | |
| Symptom/nutrition manual utilization | ||||
| Mean | SD | Range | t-Value | |
| Symptom manual usefulness rating time 1 | 2.61 | 0.9 | 1–4 | 3.27 (df=217); (P≤0.001) |
| Nutrition manual usefulness rating time 1 | 2.42 | 1.0 | 0–4 | |
| Symptom manual weekly use time 1 | 1.92 | 2.0 | 0–12 | 3.13 (df=212); (P=0.002) |
| Nutrition manual weekly use time 1 | 1.49 | 1.7 | 0–10 | |
| Symptom manual monthly use time 1 | 4.70 | 5.5 | 0–31 | 1.89 (df=207); (P=0.06) |
| Nutrition manual monthly use time 1 | 3.73 | 5.0 | 0–30 | |
| Symptom manual usefulness rating time 2 | 2.65 | 0.9 | 1–4 | 3.15 (df=214); (P=0.002) |
| Nutrition manual usefulness rating time 2 | 2.45 | 1.0 | 0–4 | |
| Symptom manual weekly use time 2 | 1.94 | 2.2 | 0–10 | 3.18 (df=197); (P≤0.002) |
| Nutrition manual weekly use time 2 | 1.45 | 1.7 | 0–7 | |
| Symptom manual monthly use time 2 | 4.80 | 5.9 | 0–30 | 2.86 (df=197); (P≤0.005) |
| Nutrition manual monthly use time 2 | 3.60 | 5.0 | 0–30 | |
Manual Efficacy Assessment
To test the efficacy of the symptom management manual compared to the nutrition manual in improving symptom intensity and frequency scores, the total symptom frequency score and the total symptom intensity score variables required normalization, as these variables were negatively skewed due to a high number of zeros (not having the symptom). Normalizing these variables was done by taking the square root of the total values for each variable. The transformed symptom intensity and frequency variables revealed a normal distribution and were used as the outcome (dependent) variables in the mixed models analyses.
Mixed Model Growth Analysis
This section reports on four models describing the iterative process in model assessment using mixed models growth analysis. For both the symptom frequency and intensity variables, the modeled trajectories of change over time and the dependent variables contributing to change over time had very similar effects. Hence, only the symptom intensity models and not the symptom frequency models are presented. The first model (Table 5, Model A) tested each individual's initial symptom intensity status at baseline and its associated variation from the mean symptom intensity value. This model is designed to show the variation in the initial symptom intensity scores only and to quantify the total variation in the symptom intensity scores. The model showed a mean symptom intensity score of 26.7 (5.17)2 with significant variation in an individual's initial status of symptom intensity scores at baseline (5.93). The estimate of the proportion of total symptom intensity variation between individuals (intraclass correlation coefficient) for the within-person and between-person variation was calculated to be 0.67 (5.93/5.93+2.90), indicating that two-thirds of the total variation in symptom intensity is attributable to differences among the participants.15
Table 5. Dependent Variable (DV): Square Root of Total Symptom Intensity Score
| Fixed Effects | Unconditional Means Model | Unconditional Growth Model | Growth Model I/C | Growth Model with I/C and Level 2 Characteristics | Guide to Coefficients in Model D |
|---|---|---|---|---|---|
| Model A | Model B | Model C | Model D | ||
| Initial status—Intercept (Standard error SE) | 5.17 (0.098)a | 5.55 (0.11)a | 5.59 (0.16)a | 4.31 (0.23)a | 1 |
| Initial status—intervention/control | −0.07 (0.21) | −0.02 (0.21) | 2 | ||
| Initial status—PI-based ARV regimen | 0.53 (0.15)a | 3 | |||
| Initial status—Comorbid illness | 0.96 (0.20)a | 4 | |||
| Initial status—Hispanic | 1.18 (0.23)a | 5 | |||
| Rate of Change—Intercept | −0.48 (0.05)a | −0.35 (0.07)a | −0.22 (0.09)a | 6 | |
| Rate of Change—Intervention/Control | −0.25 (0.11)a | −0.28 (0.11)a | 7 | ||
| Rate of Change—PI-based ARV regimen | 0.19 (0.11) | 8 | |||
| Rate of Change—Hispanic | −0.34 (0.12)a | 9 | |||
| Variance components | |||||
| Level 1 Within person | 2.90 (0.13)a | 2.40 (0.15)a | 2.40 (0.15)a | 2.40 (0.15)a | 10 |
| Level 2 In initial status | 5.93 (0.39)a | 6.73 (0.48)a | 6.74 (0.48)a | 6.0 (0.46)a | 11 |
| Level 2 In rate of change | 0.294 (0.13)a | 0.285 (0.13)a | 0.237 (0.13) | 12 | |
| Pseudo R2 statistics (variance change from prior model) | |||||
| Level 1—Within person variation | 0.17 | — | — | — | |
| Level 2—Initial status variation | — | 0.11 | 13 | ||
| Level 2—Rate of change variation | 0.03 | 0.17 | 14 | ||
| Goodness of fit (lower is better) | |||||
| Deviance statistic | 8,293.6 | 8,201.9 | 8,198.2 | 7,823.2 | 15 |
| Akaike Information Criterion (AIC) | 8,297.6 | 8,209.9 | 8,206.2 | 7,831.2 | 15 |
| Bayesian Information Criterion (BIC) | 8,308.5 | 8,231.9 | 8,228.2 | 7,852.9 | 15 |
1.Significant variation in individual baseline symptom intensity status estimate =18.41 (4.31)22.No difference between baseline symptom intensity for intervention and control groups 3.Persons taking PI-based ARV regimens have significantly higher initial average symptom intensity scores than do those not taking PIs or ARVs 4.Persons reporting comorbid illness have significantly higher initial average symptom intensity scores 5.Persons with Hispanic race have significantly higher initial average symptom intensity scores than nonHispanics 6.Both intervention and control groups show significant decline in report of symptom intensity over time 7.The intervention group showed a steeper and significant decline in report of symptom intensity over time than did the control group 8.Persons taking PI-based ARV regimens have higher average symptom intensity scores over time than do those not taking PIs or ARVs 9.Persons with Hispanic race significantly reduced their average symptom intensity scores more than did nonHispanics 10.There is significant remaining unexplained variation in the individual symptom trajectories 11.There is significant remaining unexplained variation in the initial symptom intensity scores 12.There is unexplained variation in the rates of change in symptom intensity over time but not significantly so. 13.There is 11 additional explained variance in initial symptom intensity by adding the level 2 predictors to the model 14.There is 17 additional explained variance in change in symptom intensity by adding the level 2 predictors to the model 15.The addition of predictor variables improved the model fit. | |||||
aP |
The second model (Table 5, Model B) estimated the combined intervention and control group sample to obtain the individual growth trajectories from baseline, as well as the between-person variation in trajectories. In this model, the mean symptom intensity total score at baseline was 30.80 (5.55),2 and over time, on average, both the intervention and control combined groups, showed a steady decrease in symptom intensity scores to 25.70 (5.55–0.48)2 at the one-month follow-up assessment and 21.10 (5.55–0.96)2 at the two-month follow-up assessment. The significant variances associated with each individual's baseline intercept trajectories of symptom change over the three months showed significant variation indicating symptom changes are differing for each person. This is evidenced by the between-person variability in initial status (6.73) and rate of change (0.294). The addition of the change-over-time variable reduced 17% of the variation in the initial status scores, indicating that there was some similarity in trajectories between individuals but significant variation still remained. The smaller goodness-of-fit statistics relative to model A show that the growth model is a better fit. The estimates of variation from these two unconditional models were used for subsequent model comparisons to assess any reduction in variance and improved model fit by adding Level 2 variables to further describe the sample and reduce variation.
The third model (Table 5, Model C) shows results of testing for differences in the initial report of symptom intensities and change over time by treatment arm. The mean initial symptom intensity score for the intervention group was 30.50 and was 31.25 for the control group, (t=−0.320, P=0.75), showing no significant difference in the symptom intensity scores between groups at baseline. This model again shows that, over time, the average combined groups again showed a significant decrease in symptom intensity scores to 27.45 (5.59–0.35)2 at one month and 23.91 (5.59–0.70)2 at two months. Importantly, this model reveals that the participants in the intervention group had a significantly higher decline in symptom intensity scores 24.20 (5.59–0.07–0.35–0.25),2 compared to the control group 26.73 (5.59–0.07–0.35),2 at one-month follow-up and a significantly larger decline at two-month follow-up (mean intervention=18.67, mean control=23.23, t=2.36, P=0.018) (Fig. 2). The addition of the treatment arm variable did not further explain any variation for within-person symptom status or in initial status, although the variation in the rate of change was decreased by an additional 3%. The smaller goodness-of-fit statistics relative to Models A and B show that the growth model using the intervention and control variable is a better fit.
Fig. 2
Rate of symptom intensity score change over time for the intervention and control groups. Means estimated from Table 5. Analytical Model C.
The final model (Table 5, Model D) shows the effects of adding the dependent variables to help to explain the variation in initial status and rate of change over time. Again, there was no significant difference in the baseline average symptom intensity scores between groups (mean intervention symptom score=18.41, mean control symptom score=18.58; t=−0.08, P=0.935). Individuals taking an ARV regimen that included a PI demonstrated a significantly increased initial average symptom score at baseline (0.53, t=3.56, P=0.001) and this increase in average symptom intensity was maintained over time, although not significantly (0.19, t=1.62, P=0.10). Having a comorbid illness also increased the mean symptom intensity score significantly, with a mean increase of 0.96, (t=4.89, P≤0.001). Individuals reporting their ethnicity as Hispanic and receiving care in the United States demonstrated a significantly increased mean initial symptom intensity (1.18, t=5.33, P≤0.001) and a significantly steeper decline in intensity over time, compared to nonHispanics in the sample (−0.34, t=2.89, P=0.004). The improvement in variance components by the addition of the Level 2 descriptive variables of taking a PI-based regimen, having a comorbid illness diagnosis, and being Hispanic and receiving care in the United States explained an additional 17% of the variance. A total of 20% of the variance in the final model, out of the possible 67% of the variation in symptom intensity, was identified as being attributable to differences among the participants at the outset of the analysis. The amount of unexplained variance in the Level 2 rate of change was no longer significant, indicating that the model is fairly representative to explain predictors of change in symptom intensity (and frequency) in this sample, adding evidence that this is the best model to be achieved.
Discussion
At baseline, both the intervention and control groups reported an average symptom intensity rating score of 30.25 and 31.5, respectively, out of a possible score of 192. Both groups showed a decline in intensity scores over the three-month study period, with the intervention group showing a steeper decline in symptom intensity and frequency scores.
A series of statistical models were run to test for explanatory differences in the initial report of symptom intensities and change over time between the two groups. The final model showed that, while holding all other variables constant, individuals taking an ARV regimen that included a PI had an increased initial average symptom score at baseline that was 28% higher than those not taking ARVs or not on a PI-based regimen. This increase in symptom intensity was maintained, but not significantly so, over the three-month study period. Those individuals taking a PI-based treatment regimen reported higher than expected symptoms related to body change of weight gain in the stomach area, hump on back of the neck, skinny arms/legs, and prominent leg veins as well as gas/bloating.
In individuals taking an NNRTI-based regimen, the symptom of prominent leg veins was also significantly higher. These ARV-related symptom findings are supported in prior research, as lipodystrophy was first reported in 1996 when a number of people taking protease inhibitors (PIs) began noticing abnormal changes in body shape and size. Some patients who never took a PI-based regimen but had taken an NNRTI reported similar body-shape changes.17, 18, 19 Individuals having a comorbid diagnosis that included either hypertension, hepatitis B or C, a diagnosis of depression, or diabetes showed nearly double the mean symptom intensity score at baseline, and showed higher though nonsignificant rates of change. This is expected, as the various comorbid illnesses have sequelae that are captured in the SSC-HIVrev symptom checklist. Individuals reporting Hispanic ethnicity showed a significantly increased mean initial symptom intensity, averaging nearly 2.5 times higher than nonHispanics, and also showed a steeper decline in symptom intensity that was 12% greater over the three-month periods compared to nonHispanics in the sample.
To date, the HIV literature is not conclusive regarding ethnic differences and symptoms. One study by Israelski et al. showed that Hispanics in the United States reported fewer symptoms compared to African Americans and whites with HIV/AIDS.20 However, the higher mean total symptom intensity score for individuals reporting Hispanic ethnicity from Puerto Rico compared to Hispanic ethnicity in the United States is consistent with evidence reported in earlier studies.21, 22 An important significantly lower average symptom intensity was noted in participants reporting African American ethnicity, when compared to those who identified themselves as African from the African study sites. This may be due to cultural influences related to poverty and the perception that the presence and intensity of various symptoms are placed in a lower priority in the context of need for food and shelter, and concern about illness. This subject requires further exploration in future research.
For both groups combined, individuals who rated the manuals very helpful (scores 3 and 4) at one-month and two-month follow-up assessments were significantly more likely to have lower symptom intensity scores and scores that decreased at a higher rate over time compared to those who rated the manuals lower (t=2.57, P=0.01). This suggests an expectation that the manuals are helpful, implying that there may be a measure of optimism in using the manuals or that the symptom management was perceived as being more helpful when other resources were not. These individuals may have a higher degree of self-efficacy in their illness management and perceive the manuals as support for the efficacious behaviors in self-care management.
The study limitations include the self-report description of the assessment and the recruitment of the study participants by a variety of strategies (self-administered questionnaire, read to participant). In addition, the majority of participants were from the United States, which may bias the self-report of symptoms and self-care strategies to those of a Western culture. The study did not include validation of medical comorbidities, including psychiatric diagnoses. Despite the limitations, the study has notable strengths, including the international sample, adequate power, and the use of validated instruments.
Conclusions
These data support the use of an HIV symptom manual with self-care symptom management strategies for individuals living with HIV/AIDS. Overall, our results show that participants who used either manual (symptom management or nutrition) were likely to have a decrease in symptom frequency and symptom intensity over time. Importantly, the findings from this randomized controlled trial show that the effects of using targeted symptom-specific strategies were statistically superior to general nutrition information in producing a greater reduction in symptom frequency and intensity. The improvement in symptom scores for both groups provides evidence to test an intervention focusing on improved self-care efficacy to help individuals gain further from these tailored self-care measures.
The chronic and uncertain nature of HIV disease may lead to a number of physiological and psychological symptoms that potentially impact the lives of persons living with HIV/AIDS. Many of these HIV-related symptoms frequently go unrecognized by health care providers and are often underreported, minimized, or normalized by persons with HIV/AIDS. The information provided in this study will help health care providers become more aware of self-management strategies that persons with HIV/AIDS feel are most effective in managing a large number of symptoms and also help them to assist patients in making informed choices. These strategies can be provided to the patient along with medication and other treatments in the event of intense, disabling symptoms. Cross-cultural differences and analyses of strategies for self-managing HIV-related symptoms are important areas for further research, particularly as the disease and its treatment increases in areas of the world where self-care is the primary approach to managing HIV. Although ARV medications are critical to combating the disease, self-care strategies offer important and successful approaches to limiting the negative effects of HIV.
References
- . The revised Sign and Symptom Check-List for HIV (SSC-HIVrev). J Assoc Nurses AIDS Care. 2001;12:60–70
- . Symptom management in HIV-infected patients. J Assoc Nurses AIDS Care. 2004;15:7S–13S
- . The use of highly active antiretroviral therapy (HAART) in patients with advanced HIV infection: impact on medical, palliative care, and quality of life outcomes. J Pain Symptom Manage. 2001;21:41–51
- . Symptom status and quality of life in HIV disease. Paper presented at the Fifteenth annual ANAC Conference. San Francisco: California; 2002;
- . The influence of symptoms on quality of life among HIV-infected women. West J Nurs Res. 2004;26:9–23discussion 24–30
- Validation of the Sign and Symptom Checklist for Persons with HIV Disease (SSC-HIV). J Adv Nurs. 1999;30:1041–1049
- . Suggestions for clinical nursing research: symptom management in AIDS patients. J Assoc Nurses AIDS Care. 1993;4:13–17
- . Investigating chronic symptoms in HIV: an opportunity for collaborative nursing research. J Assoc Nurses AIDS Care. 1995;6:13–17
- . Daily life for eight urban gay men with HIV/AIDS. Am J Occup Ther. 2000;54:197–206
- . Changes in symptoms and health-related quality of life in a nationally representative sample of adults in treatment for HIV. Qual Life Res. 2006;15:951–958
- Strategies for self-management of HIV-related anxiety. AIDS Care. 2006;18:597–607
- Prayer as a complementary health strategy for managing HIV-related symptoms among ethnically diverse patients. Holist Nurs Pract. 2006;20:65–72
- . Living well with HIV/AIDS. A manual on nutritional care and support for people living with HIV/AIDS. Rome: WHO/FAO; 2002;
- . SPSS Base 13.0 for Windows User's Guide. Chicago: SPSS Inc.; 2004;
- . Applied longitudinal data analysis: modeling change and event occurrence. New York, NY: Oxford University Press; 2003;
- . Limitations of ordinary least squares models in analyzing repeated measures data. Med Sci Sports Exerc. 2004;36:2144–2148
- Lipodystrophy-associated morphological, cholesterol and triglyceride abnormalities in a population-based HIV/AIDS treatment database. AIDS. 2001;15:231–239
- Preliminary guidelines for the evaluation and management of dyslipidemia in adults infected with human immunodeficiency virus and receiving antiretroviral therapy: recommendations of the Adult AIDS Clinical Trial Group Cardiovascular Disease Focus Group. Clin Infect Dis. 2000;31:1216–1224
- Increased fat accumulation in the liver in HIV-infected patients with antiretroviral therapy-associated lipodystrophy. AIDS. 2002;16:2183–2193
- Psychiatric co-morbidity in vulnerable populations receiving primary care for HIV/AIDS. AIDS Care. 2007;19:220–225
- . Somatic complaints in primary care: further examining the validity of the Patient Health Questionnaire (PHQ-15). Psychosomatics. 2006;47:392–398
- . Manifestation of depressive symptoms among adolescents. A comparison of Mexican Americans with the majority and other minority populations. J Nerv Ment Dis. 1992;180:627–633
PII: S0885-3924(08)00133-4
doi:10.1016/j.jpainsymman.2007.10.011
© 2008 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.
Volume 36, Issue 3 , Pages 235-246, September 2008
