Fatigue Management in HIV

Not Applicable

Completed

Interventions: Behavioral: Sleep and Rhythm Intervention
Behavioral: Dietary Modifications

Brief Summary: 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.

Recruitment & Eligibility

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.).

Arm && Interventions

Group	Intervention	Description
Sleep and Rhythm Intervention	Sleep and Rhythm Intervention	This arm receives a 4-week behavioral intervention aimed at improving sleep and circadian rhythms, and thereby reducing fatigue.
Dietary Modifications	Dietary Modifications	This arm receives a 4-week placebo intervention focused on dietary modifications for reducing fatigue.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations (1): University of California, San Francisco
🇺🇸
San Francisco, California, United States