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Fatigue Management in HIV

Primary Purpose

Fatigue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep and Rhythm Intervention
Dietary Modifications
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring fatigue, HIV, behavioral intervention, sleep

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.).

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sleep and Rhythm Intervention

Dietary Modifications

Arm Description

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

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

Outcomes

Primary Outcome Measures

Morning fatigue severity
self-report ratings of morning fatigue severity (Lee Fatigue Scale)
Evening fatigue severity
self-report ratings of evening fatigue severity (Lee Fatigue Scale)
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)
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)
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)
Attrition
Proportion of participants who do not complete the study
Satisfaction with the intervention
Ratings of participant satisfaction with the 6 intervention components
Adherence to intervention
Self-reported adherence to each of the 6 behavioral intervention components

Secondary Outcome Measures

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

Full Information

First Posted
April 25, 2014
Last Updated
June 1, 2016
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02126007
Brief Title
Fatigue Management in HIV
Official Title
Fatigue Management in HIV: A Sleep and Circadian Rhythm Pilot Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
fatigue, HIV, behavioral intervention, sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep and Rhythm Intervention
Arm Type
Experimental
Arm Description
This arm receives a 4-week behavioral intervention aimed at improving sleep and circadian rhythms, and thereby reducing fatigue.
Arm Title
Dietary Modifications
Arm Type
Placebo Comparator
Arm Description
This arm receives a 4-week placebo intervention focused on dietary modifications for reducing fatigue.
Intervention Type
Behavioral
Intervention Name(s)
Sleep and Rhythm Intervention
Intervention Type
Behavioral
Intervention Name(s)
Dietary Modifications
Primary Outcome Measure Information:
Title
Morning fatigue severity
Description
self-report ratings of morning fatigue severity (Lee Fatigue Scale)
Time Frame
3 months
Title
Evening fatigue severity
Description
self-report ratings of evening fatigue severity (Lee Fatigue Scale)
Time Frame
3 months
Title
Lack of energy - frequency
Description
self-report rating of the frequency of a lack of energy in past week (single item from Memorial Symptom Assessment Scale)
Time Frame
3 months
Title
Lack of energy - severity
Description
self-report rating of the severity of a lack of energy in past week (single item from Memorial Symptom Assessment Scale)
Time Frame
3 months
Title
Lack of energy - distress
Description
self-report rating of the distress due to a lack of energy in past week (single item from Memorial Symptom Assessment Scale)
Time Frame
3 months
Title
Attrition
Description
Proportion of participants who do not complete the study
Time Frame
3 months
Title
Satisfaction with the intervention
Description
Ratings of participant satisfaction with the 6 intervention components
Time Frame
3 months
Title
Adherence to intervention
Description
Self-reported adherence to each of the 6 behavioral intervention components
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Objectively measured sleep duration
Description
Mean night-time sleep duration in minutes during the 7-day assessment period as estimated by FitBit monitor.
Time Frame
3 months
Title
Objectively measured sleep quality
Description
Mean number of night-time wakes during the 7-day assessment period as estimated by FitBit monitor.
Time Frame
3 months
Title
Objectively-measured activity
Description
Mean number of daily steps during 7-day assessment period
Time Frame
3 months
Title
Sleep medication use
Description
Self-reported use of sleep medication during the 7-day assessment period
Time Frame
3 months
Title
Self-reported sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI) total score
Time Frame
3 months
Title
Depressed mood
Description
Hospital Anxiety and Depression Scale (HADS) - depression subscore
Time Frame
3 months
Title
Anxious mood
Description
Hospital Anxiety and Depression Scale (HADS) - anxiety subscore
Time Frame
3 months
Title
Physical function
Description
Short Form (SF)-36 physical function score
Time Frame
3 months
Title
Cognitive function
Description
SF-36 cognitive function score
Time Frame
3 months
Title
Medication adherence
Description
AIDS Clinical Trials Group (ACTG) Adherence score
Time Frame
3 months
Title
Daytime sleepiness
Description
Epworth Sleepiness Scale (ESS) - total score
Time Frame
3 months
Title
Fatigue interference with daytime function
Description
Fatigue Severity Scale - mean score
Time Frame
3 months
Title
Sleep behavior
Description
Sleep Behavior Self-Rating Scale (SBSRS) - total score
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn A Lee, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0606
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31612533
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.
Results Reference
derived

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Fatigue Management in HIV

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