Fatigue Management in HIV

Study Overview
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Brief Summary
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This randomized clinical trial (RCT) pilot study as two main objectives: determine the overall feasibility of a behavioral intervention for managing fatigue among older adults with HIV infection. to estimate effect sizes for group differences at 1, 2, and 3 months on five dimensions of fatigue. The investigators hypothesize that adherence, satisfaction, and attrition will be similar for the active intervention group and the attention control group. The investigators also hypothesize that all five dimensions will improve in the intervention group compared to controls over time, and that Cohen's d (Standard Deviation units) will be greater than 0.5 SD units for all five fatigue dimensions at all three post-intervention time points.

Official Title
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Fatigue Management in HIV: A Sleep and Circadian Rhythm Pilot Intervention

Conditions
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Fatigue

Intervention / Treatment
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* Behavioral: Sleep and Rhythm Intervention
* Behavioral: Dietary Modifications


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of HIV infection Be at least 50 years of age Have a Fatigue Severity Score13 > 4.0 Be retired or on disability Be willing to wear a FitBit One Tracker and keep a 7-day diary at 4 time points (electronic, paper, or other convenient format) Be able to speak, understand, and read English Have a telephone, cell phone, computer access, or other means of communication Exclusion Criteria: Current temporary, part-time, or full-time employment Planning to travel or be away from home during the 3-month study time frame Being pre- or peri-menopausal because of fluctuations in vasomotor symptoms over time Taking hormones to treat symptoms of menopause Brief Interview for Mental Status score < 13 AIDS dementia diagnosis Diagnosed sleep disorder that would not be responsive to behavioral interventions (sleep apnea, restless legs, etc.).

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep and Rhythm Intervention<br>This arm receives a 4-week behavioral intervention aimed at improving sleep and circadian rhythms, and thereby reducing fatigue. | Behavioral: Sleep and Rhythm Intervention<br> <br> |
| Placebo Comparator: Dietary Modifications<br>This arm receives a 4-week placebo intervention focused on dietary modifications for reducing fatigue. | Behavioral: Dietary Modifications<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morning fatigue severity | self-report ratings of morning fatigue severity (Lee Fatigue Scale) | 3 months | 
| Evening fatigue severity | self-report ratings of evening fatigue severity (Lee Fatigue Scale) | 3 months | 
| Lack of energy - frequency | self-report rating of the frequency of a lack of energy in past week (single item from Memorial Symptom Assessment Scale) | 3 months | 
| Lack of energy - severity | self-report rating of the severity of a lack of energy in past week (single item from Memorial Symptom Assessment Scale) | 3 months | 
| Lack of energy - distress | self-report rating of the distress due to a lack of energy in past week (single item from Memorial Symptom Assessment Scale) | 3 months | 
| Attrition | Proportion of participants who do not complete the study | 3 months | 
| Satisfaction with the intervention | Ratings of participant satisfaction with the 6 intervention components | 3 months | 
| Adherence to intervention | Self-reported adherence to each of the 6 behavioral intervention components | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objectively measured sleep duration | Mean night-time sleep duration in minutes during the 7-day assessment period as estimated by FitBit monitor. | 3 months | 
| Objectively measured sleep quality | Mean number of night-time wakes during the 7-day assessment period as estimated by FitBit monitor. | 3 months | 
| Objectively-measured activity | Mean number of daily steps during 7-day assessment period | 3 months | 
| Sleep medication use | Self-reported use of sleep medication during the 7-day assessment period | 3 months | 
| Self-reported sleep quality | Pittsburgh Sleep Quality Index (PSQI) total score | 3 months | 
| Depressed mood | Hospital Anxiety and Depression Scale (HADS) - depression subscore | 3 months | 
| Anxious mood | Hospital Anxiety and Depression Scale (HADS) - anxiety subscore | 3 months | 
| Physical function | Short Form (SF)-36 physical function score | 3 months | 
| Cognitive function | SF-36 cognitive function score | 3 months | 
| Medication adherence | AIDS Clinical Trials Group (ACTG) Adherence score | 3 months | 
| Daytime sleepiness | Epworth Sleepiness Scale (ESS) - total score | 3 months | 
| Fatigue interference with daytime function | Fatigue Severity Scale - mean score | 3 months | 
| Sleep behavior | Sleep Behavior Self-Rating Scale (SBSRS) - total score | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatigue, HIV, behavioral intervention, sleep