Fatigue Management in HIV
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 6/3/2016 |
| Start Date: | October 2014 |
| End Date: | December 2015 |
Fatigue Management in HIV: A Sleep and Circadian Rhythm Pilot Intervention
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.
- 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.
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.).
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