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Fatigue | Fatigue Management in HIV

Fatigue research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Fatigue

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Sleep and Rhythm Intervention

Behavioral:Dietary Modifications

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Completed

Start Date: October 2014

Completed Date: December 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Morning fatigue severity

Secondary Outcome: Objectively measured sleep duration

Study sponsors, principal investigator, and references

Principal Investigator: Kathryn A Lee, PhD

Lead Sponsor: University of California, San Francisco

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02126007

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