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Completed

NCT Number: NCT02126007

Fatigue Management in HIV

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.

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Key information

Conditions

Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143-0606, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Sleep and Rhythm Intervention

Behavioral

Dietary Modifications

Behavioral

Primary outcomes

  1. Morning fatigue severity

    Time frame: 3 months

    self-report ratings of morning fatigue severity (Lee Fatigue Scale)

  2. Evening fatigue severity

    Time frame: 3 months

    self-report ratings of evening fatigue severity (Lee Fatigue Scale)

  3. Lack of energy - frequency

    Time frame: 3 months

    self-report rating of the frequency of a lack of energy in past week (single item from Memorial Symptom Assessment Scale)

  4. Lack of energy - severity

    Time frame: 3 months

    self-report rating of the severity of a lack of energy in past week (single item from Memorial Symptom Assessment Scale)

  5. Lack of energy - distress

    Time frame: 3 months

    self-report rating of the distress due to a lack of energy in past week (single item from Memorial Symptom Assessment Scale)

  6. Attrition

    Time frame: 3 months

    Proportion of participants who do not complete the study

  7. Satisfaction with the intervention

    Time frame: 3 months

    Ratings of participant satisfaction with the 6 intervention components

  8. Adherence to intervention

    Time frame: 3 months

    Self-reported adherence to each of the 6 behavioral intervention components

Secondary outcomes

  1. Objectively measured sleep duration

    Time frame: 3 months

    Mean night-time sleep duration in minutes during the 7-day assessment period as estimated by FitBit monitor.

  2. Objectively measured sleep quality

    Time frame: 3 months

    Mean number of night-time wakes during the 7-day assessment period as estimated by FitBit monitor.

  3. Objectively-measured activity

    Time frame: 3 months

    Mean number of daily steps during 7-day assessment period

  4. Sleep medication use

    Time frame: 3 months

    Self-reported use of sleep medication during the 7-day assessment period

  5. Self-reported sleep quality

    Time frame: 3 months

    Pittsburgh Sleep Quality Index (PSQI) total score

  6. Depressed mood

    Time frame: 3 months

    Hospital Anxiety and Depression Scale (HADS) - depression subscore

  7. Anxious mood

    Time frame: 3 months

    Hospital Anxiety and Depression Scale (HADS) - anxiety subscore

  8. Physical function

    Time frame: 3 months

    Short Form (SF)-36 physical function score

  9. Cognitive function

    Time frame: 3 months

    SF-36 cognitive function score

  10. Medication adherence

    Time frame: 3 months

    AIDS Clinical Trials Group (ACTG) Adherence score

  11. Daytime sleepiness

    Time frame: 3 months

    Epworth Sleepiness Scale (ESS) - total score

  12. Fatigue interference with daytime function

    Time frame: 3 months

    Fatigue Severity Scale - mean score

  13. Sleep behavior

    Time frame: 3 months

    Sleep Behavior Self-Rating Scale (SBSRS) - total score

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 29, 2014
Registry last updated
Jun 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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