Fatigue Management in HIV

Completed · Not applicable

Conditions studied: Fatigue

In brief

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.

Key facts

Study ID

NCT02126007

Run by

University of California, San Francisco

People needed

53

Starts

2014-10-01

Expected to finish

2015-12-01

Last updated by the study team

2016-06-02

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.).

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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