Fatigue Management in HIV

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02126007
First received: April 25, 2014
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Fatigue
Behavioral: Sleep and Rhythm Intervention
Behavioral: Dietary Modifications

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Fatigue Management in HIV: A Sleep and Circadian Rhythm Pilot Intervention

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Morning fatigue severity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    self-report ratings of morning fatigue severity (Lee Fatigue Scale)

  • Evening fatigue severity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    self-report ratings of evening fatigue severity (Lee Fatigue Scale)

  • Lack of energy - frequency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    self-report rating of the distress due to a lack of energy in past week (single item from Memorial Symptom Assessment Scale)

  • Attrition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Proportion of participants who do not complete the study

  • Satisfaction with the intervention [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Ratings of participant satisfaction with the 6 intervention components

  • Adherence to intervention [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Self-reported adherence to each of the 6 behavioral intervention components


Secondary Outcome Measures:
  • Objectively measured sleep duration [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Mean night-time sleep duration in minutes during the 7-day assessment period as estimated by FitBit monitor.

  • Objectively measured sleep quality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Mean number of night-time wakes during the 7-day assessment period as estimated by FitBit monitor.

  • Objectively-measured activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Mean number of daily steps during 7-day assessment period

  • Sleep medication use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Self-reported use of sleep medication during the 7-day assessment period

  • Self-reported sleep quality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Pittsburgh Sleep Quality Index (PSQI) total score

  • Depressed mood [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale (HADS) - depression subscore

  • Anxious mood [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale (HADS) - anxiety subscore

  • Physical function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Short Form (SF)-36 physical function score

  • Cognitive function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    SF-36 cognitive function score

  • Medication adherence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    AIDS Clinical Trials Group (ACTG) Adherence score

  • Daytime sleepiness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Epworth Sleepiness Scale (ESS) - total score

  • Fatigue interference with daytime function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Fatigue Severity Scale - mean score

  • Sleep behavior [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Sleep Behavior Self-Rating Scale (SBSRS) - total score


Estimated Enrollment: 60
Study Start Date: November 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02126007

Contacts
Contact: Kathryn A Lee, PhD 415-476-4442 kathyn.lee@nursing.ucsf.edu

Locations
United States, California
University of California, San Francisco Not yet recruiting
San Francisco, California, United States, 94143-0606
Contact: Caryl Gay    650-208-5733    carylgay@yahoo.com   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Kathryn A Lee, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02126007     History of Changes
Other Study ID Numbers: HIV-fatigue
Study First Received: April 25, 2014
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
fatigue
HIV
behavioral intervention
sleep

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014