Fatigue Management in HIV

University of California, San Francisco53 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Fatigue

Interventions

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.).

Outcomes

Primary Outcomes

Morning fatigue severity

self-report ratings of morning fatigue severity (Lee Fatigue Scale)

Time frame: 3 months

Evening fatigue severity

self-report ratings of evening fatigue severity (Lee Fatigue Scale)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 3 months

Attrition

Proportion of participants who do not complete the study

Time frame: 3 months

Satisfaction with the intervention

Ratings of participant satisfaction with the 6 intervention components

Time frame: 3 months

Adherence to intervention

Self-reported adherence to each of the 6 behavioral intervention components

Time frame: 3 months

Secondary Outcomes

Objectively measured sleep duration

Mean night-time sleep duration in minutes during the 7-day assessment period as estimated by FitBit monitor.

Time frame: 3 months

Objectively measured sleep quality

Mean number of night-time wakes during the 7-day assessment period as estimated by FitBit monitor.

Time frame: 3 months

Objectively-measured activity

Mean number of daily steps during 7-day assessment period

Time frame: 3 months

Sleep medication use

Self-reported use of sleep medication during the 7-day assessment period

Time frame: 3 months

Self-reported sleep quality

Pittsburgh Sleep Quality Index (PSQI) total score

Time frame: 3 months

Depressed mood

Hospital Anxiety and Depression Scale (HADS) - depression subscore

Time frame: 3 months

Anxious mood

Hospital Anxiety and Depression Scale (HADS) - anxiety subscore

Time frame: 3 months

Physical function

Short Form (SF)-36 physical function score

Time frame: 3 months

Cognitive function

SF-36 cognitive function score

Time frame: 3 months

Medication adherence

AIDS Clinical Trials Group (ACTG) Adherence score

Time frame: 3 months

Daytime sleepiness

Epworth Sleepiness Scale (ESS) - total score

Time frame: 3 months

Fatigue interference with daytime function

Fatigue Severity Scale - mean score

Time frame: 3 months

Sleep behavior

Sleep Behavior Self-Rating Scale (SBSRS) - total score

Time frame: 3 months

Fatigue Management in HIV

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes