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Fatigue Management in HIV

NCT02126007 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2016-06-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Sleep and Rhythm Intervention

BEHAVIORAL

Dietary Modifications

Sponsors & Collaborators

Principal Investigators

  • Kathryn A Lee, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-09-30
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02126007 on ClinicalTrials.gov