Fatigue Management in HIV

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126007
• Other study ID #: HIV-fatigue
• Status: Completed
• Phase: N/A
• First received: April 25, 2014
• Last updated: June 1, 2016
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue

Intervention

Behavioral:
• Sleep and Rhythm Intervention

• Dietary Modifications

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morning fatigue severity	self-report ratings of morning fatigue severity (Lee Fatigue Scale)	3 months	No
Primary	Evening fatigue severity	self-report ratings of evening fatigue severity (Lee Fatigue Scale)	3 months	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Attrition	Proportion of participants who do not complete the study	3 months	No
Primary	Satisfaction with the intervention	Ratings of participant satisfaction with the 6 intervention components	3 months	No
Primary	Adherence to intervention	Self-reported adherence to each of the 6 behavioral intervention components	3 months	No
Secondary	Objectively measured sleep duration	Mean night-time sleep duration in minutes during the 7-day assessment period as estimated by FitBit monitor.	3 months	No
Secondary	Objectively measured sleep quality	Mean number of night-time wakes during the 7-day assessment period as estimated by FitBit monitor.	3 months	No
Secondary	Objectively-measured activity	Mean number of daily steps during 7-day assessment period	3 months	No
Secondary	Sleep medication use	Self-reported use of sleep medication during the 7-day assessment period	3 months	No
Secondary	Self-reported sleep quality	Pittsburgh Sleep Quality Index (PSQI) total score	3 months	No
Secondary	Depressed mood	Hospital Anxiety and Depression Scale (HADS) - depression subscore	3 months	No
Secondary	Anxious mood	Hospital Anxiety and Depression Scale (HADS) - anxiety subscore	3 months	No
Secondary	Physical function	Short Form (SF)-36 physical function score	3 months	No
Secondary	Cognitive function	SF-36 cognitive function score	3 months	No
Secondary	Medication adherence	AIDS Clinical Trials Group (ACTG) Adherence score	3 months	No
Secondary	Daytime sleepiness	Epworth Sleepiness Scale (ESS) - total score	3 months	No
Secondary	Fatigue interference with daytime function	Fatigue Severity Scale - mean score	3 months	No
Secondary	Sleep behavior	Sleep Behavior Self-Rating Scale (SBSRS) - total score	3 months	No