Fatigue
Conditions
Keywords
fatigue, HIV, behavioral intervention, sleep
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.
Interventions
BEHAVIORALSleep and Rhythm Intervention
BEHAVIORALDietary Modifications
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morning fatigue severity | 3 months | self-report ratings of morning fatigue severity (Lee Fatigue Scale) |
| 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) |
| 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) |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Self-reported sleep quality | 3 months | Pittsburgh Sleep Quality Index (PSQI) total score |
| Medication adherence | 3 months | AIDS Clinical Trials Group (ACTG) Adherence score |
| Cognitive function | 3 months | SF-36 cognitive function score |
| Fatigue interference with daytime function | 3 months | Fatigue Severity Scale - mean score |
| Sleep behavior | 3 months | Sleep Behavior Self-Rating Scale (SBSRS) - total score |
| Daytime sleepiness | 3 months | Epworth Sleepiness Scale (ESS) - total score |
| Depressed mood | 3 months | Hospital Anxiety and Depression Scale (HADS) - depression subscore |
| Anxious mood | 3 months | Hospital Anxiety and Depression Scale (HADS) - anxiety subscore |
| Physical function | 3 months | Short Form (SF)-36 physical function score |
| Objectively measured sleep duration | 3 months | Mean night-time sleep duration in minutes during the 7-day assessment period as estimated by FitBit monitor. |
| Objectively measured sleep quality | 3 months | Mean number of night-time wakes during the 7-day assessment period as estimated by FitBit monitor. |
| Objectively-measured activity | 3 months | Mean number of daily steps during 7-day assessment period |
| Sleep medication use | 3 months | Self-reported use of sleep medication during the 7-day assessment period |
Countries
United States
Outcome results
None listed