Fatigue Management in HIV

University of California San Francisco (UCSF)

Status: Completed

Conditions: Fatigue

Treatments: Behavioral: Sleep and Rhythm Intervention; Behavioral: Dietary Modifications

Study type: Interventional

Funder types: Other

Identifiers

NCT02126007

HIV-fatigue

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups, including a placebo group

Sleep and Rhythm Intervention

Experimental group

Description:

This arm receives a 4-week behavioral intervention aimed at improving sleep and circadian rhythms, and thereby reducing fatigue.

Treatment:

Behavioral: Sleep and Rhythm Intervention

Dietary Modifications

Placebo Comparator group

Description:

This arm receives a 4-week placebo intervention focused on dietary modifications for reducing fatigue.

Treatment:

Behavioral: Dietary Modifications