Clinical trial NCT02126007: Fatigue Management in HIV
Official title: Fatigue Management in HIV: A Sleep and Circadian Rhythm Pilot Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Keywords: fatigue
HIV
behavioral intervention
sleep
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 53
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.).

Primary outcomes:
measure: Morning fatigue severity
timeFrame: 3 months
measure: Evening fatigue severity
timeFrame: 3 months
measure: Lack of energy - frequency
timeFrame: 3 months
measure: Lack of energy - severity
timeFrame: 3 months
measure: Lack of energy - distress
timeFrame: 3 months
measure: Attrition
timeFrame: 3 months
measure: Satisfaction with the intervention
timeFrame: 3 months
measure: Adherence to intervention
timeFrame: 3 months
Secondary outcomes:
measure: Objectively measured sleep duration
timeFrame: 3 months
measure: Objectively measured sleep quality
timeFrame: 3 months
measure: Objectively-measured activity
timeFrame: 3 months
measure: Sleep medication use
timeFrame: 3 months
measure: Self-reported sleep quality
timeFrame: 3 months
measure: Depressed mood
timeFrame: 3 months
measure: Anxious mood
timeFrame: 3 months
measure: Physical function
timeFrame: 3 months
measure: Cognitive function
timeFrame: 3 months
measure: Medication adherence
timeFrame: 3 months
measure: Daytime sleepiness
timeFrame: 3 months
measure: Fatigue interference with daytime function
timeFrame: 3 months
measure: Sleep behavior
timeFrame: 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Kathryn A Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.