Fatigue Management in HIV

Fatigue Management in HIV: A Sleep and Circadian Rhythm Pilot Intervention

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.

Study Overview

• Status: Completed
• Conditions: Fatigue
• Intervention / Treatment: Behavioral: Sleep and Rhythm Intervention; Behavioral: Dietary Modifications

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143-0606
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep and Rhythm Intervention; This arm receives a 4-week behavioral intervention aimed at improving sleep and circadian rhythms, and thereby reducing fatigue.	Behavioral: Sleep and Rhythm Intervention
Placebo Comparator: Dietary Modifications; This arm receives a 4-week placebo intervention focused on dietary modifications for reducing fatigue.	Behavioral: Dietary Modifications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morning fatigue severity	self-report ratings of morning fatigue severity (Lee Fatigue Scale)	3 months
Evening fatigue severity	self-report ratings of evening fatigue severity (Lee Fatigue Scale)	3 months
Lack of energy - frequency	self-report rating of the frequency of a lack of energy in past week (single item from Memorial Symptom Assessment Scale)	3 months
Lack of energy - severity	self-report rating of the severity of a lack of energy in past week (single item from Memorial Symptom Assessment Scale)	3 months
Lack of energy - distress	self-report rating of the distress due to a lack of energy in past week (single item from Memorial Symptom Assessment Scale)	3 months
Attrition	Proportion of participants who do not complete the study	3 months
Satisfaction with the intervention	Ratings of participant satisfaction with the 6 intervention components	3 months
Adherence to intervention	Self-reported adherence to each of the 6 behavioral intervention components	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objectively measured sleep duration	Mean night-time sleep duration in minutes during the 7-day assessment period as estimated by FitBit monitor.	3 months
Objectively measured sleep quality	Mean number of night-time wakes during the 7-day assessment period as estimated by FitBit monitor.	3 months
Objectively-measured activity	Mean number of daily steps during 7-day assessment period	3 months
Sleep medication use	Self-reported use of sleep medication during the 7-day assessment period	3 months
Self-reported sleep quality	Pittsburgh Sleep Quality Index (PSQI) total score	3 months
Depressed mood	Hospital Anxiety and Depression Scale (HADS) - depression subscore	3 months
Anxious mood	Hospital Anxiety and Depression Scale (HADS) - anxiety subscore	3 months
Physical function	Short Form (SF)-36 physical function score	3 months
Cognitive function	SF-36 cognitive function score	3 months
Medication adherence	AIDS Clinical Trials Group (ACTG) Adherence score	3 months
Daytime sleepiness	Epworth Sleepiness Scale (ESS) - total score	3 months
Fatigue interference with daytime function	Fatigue Severity Scale - mean score	3 months
Sleep behavior	Sleep Behavior Self-Rating Scale (SBSRS) - total score	3 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Kathryn A Lee, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 25, 2014
• First Submitted That Met QC Criteria: April 28, 2014
• First Posted (Estimate): April 29, 2014

Study Record Updates

• Last Update Posted (Estimate): June 2, 2016
• Last Update Submitted That Met QC Criteria: June 1, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: fatigue; sleep; HIV; behavioral intervention
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: HIV-fatigue