Fatigue Management in HIV

NCT02126007 | Completed

• 1 other identifier: HIV-fatigue
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue

Keywords

fatigue; HIV; behavioral intervention; sleep

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (13)

• Objectively measured sleep duration

  3 months

• Objectively measured sleep quality

  3 months

• Objectively-measured activity

  3 months

• Sleep medication use

  3 months

• Self-reported sleep quality

  3 months

Study Arms (2)

Sleep and Rhythm Intervention

EXPERIMENTAL

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

Behavioral: Sleep and Rhythm Intervention

Dietary Modifications

PLACEBO COMPARATOR

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

Behavioral: Dietary Modifications

Interventions

Sleep and Rhythm Intervention BEHAVIORAL

Sleep and Rhythm Intervention

Dietary Modifications BEHAVIORAL

Dietary Modifications

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143-0606, United States

Location

Related Publications (1)

• 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.

  PMID: 31612533 DERIVED

MeSH Terms

Conditions

Fatigue

Interventions

Sleep; Diet Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutrition Therapy; Therapeutics

Study Officials

• Kathryn A Lee, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: April 29, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 2, 2016

Record last verified: 2016-06

Locations

US (1)