Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2014-10-31
2015-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Dietary Modifications
This arm receives a 4-week placebo intervention focused on dietary modifications for reducing fatigue.
Dietary Modifications
Sleep and Rhythm Intervention
This arm receives a 4-week behavioral intervention aimed at improving sleep and circadian rhythms, and thereby reducing fatigue.
Sleep and Rhythm Intervention
Interventions
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Sleep and Rhythm Intervention
Dietary Modifications
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.).
50 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Kathryn A Lee, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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References
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Lee KA, Jong S, Gay CL. Fatigue management for adults living with HIV: A randomized controlled pilot study. Res Nurs Health. 2020 Jan;43(1):56-67. doi: 10.1002/nur.21987. Epub 2019 Oct 14.
Other Identifiers
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HIV-fatigue
Identifier Type: -
Identifier Source: org_study_id
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