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Completed

NCT Number: NCT02864719

An Intervention for Cardiac Arrest Survivors With Chronic Fatigue

The primary aim was to examine the feasibility of an Energy Conservation + Problem Solving Therapy (EC+PST) intervention delivered over the telephone and to evaluate the preliminary intervention effect on fatigue impact in daily activities in post-cardiac arrest (CA) adults with chronic fatigue.

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Key information

Conditions

Heart Arrest Cardiac Arrest Cardiovascular Diseases Fatigue Heart Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The primary aim was to examine the feasibility of recruiting and retaining participants for an Energy Conservation + Problem Solving Therapy (EC+PST) intervention delivered over the telephone, to evaluate the acceptability of the intervention, and to assess the appropriateness of the outcome measures. The secondary aim was to evaluate the preliminary intervention effect on fatigue impact, activity performance, and participation in daily activities in post-cardiac arrest (CA) adults with chronic fatigue.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 3 months post-cardiac arrest
  • Presence of moderate-to-severe fatigue: ≥ 4 score on the Fatigue Severity Scale
  • Availability of landline telephone or cell phone
  • Living within 150 miles of the University of Pittsburgh, Oakland
  • Functional English fluency and literacy
  • Intact cognition
  • Community living

Treatment and study plan

Energy Conservation+Problem Solving Therapy

Other

The intervention was delivered by telephone. Each EC+PST intervention session was planned to last approximately 45 minutes and occur twice a week for up to 4 weeks. Sessions terminated when the participants identified and solved two fatigue-related problems of their choice or had participated in the intervention for eight sessions. A Participant Workbook was used throughout the intervention. During eight intervention sessions, participants identified two fatigue-related problems and solutions for them, implemented the solution plans, and reviewed the implementations.

Primary outcomes

  1. Number of people who completed their study participation

    Time frame: Week 5

    Assessing the feasibility of recruitment and retention

  2. Number of participants who successfully identified and solved fatigue-related problems

    Time frame: Week 5

    Assessing the feasibility of telephone intervention delivery

  3. Client Satisfaction Questionnaire - 8

    Time frame: Week 5

    • Assessing the participants' satisfaction and the acceptability of the intervention
    • Four-point scale ranging from 1 to 4, and a total score ranging from 8 - 32 with higher scores indicating greater satisfaction

  4. Understanding of Materials Scale

    Time frame: Week 5

    • Assessing the clarity of the Participant Workbook and the acceptability of the intervention
    • Five-point scale ranging from 1 (strongly disagree) to 5 (strongly agree), and a total score ranging from 0 to 50, with higher scores indicating greater understanding of the workbook

Secondary outcomes

  1. Modified Fatigue Impact Scale

    Time frame: Week 0 and Week 5

    • Assessing how fatigue has impacted performance in functional activities
    • 21 items in three subscales with scores ranging from 0 to 84: physical, cognitive, and psychosocial subscales. The higher the total scores, the greater the impact of fatigue

  2. Fatigue Severity Scale

    Time frame: Week 0 and Week 5

    • Measuring the severity of fatigue by self-report
    • Total score is the mean of scores ranging from 1 to 7, and a higher score indicates having more severe fatigue.

  3. Patient-Reported Outcomes Measurement Information System Fatigue Scale

    Time frame: Week 0 and Week 5

    • Measuring overall fatigue by self-report and computerized adaptive test
    • Total score ranging from 10 to 90 with the average score of the US general population is 50. The higher the total score, the worse the fatigue.

  4. Performance Assessment of Self-Care Skills - Self-report (PASS-SR)

    Time frame: Week 0 and Week 5

    • Measuring perceived performance in activities of daily living by self-report
    • The total mean scores (habit and skill separately) ranging from 3 to 0, and the higher mean score indicates less difficulty in performing activities of daily living

  5. Functional Activities Questionnaire

    Time frame: Week 0 and Week 5

    • Measuring perceived performance in higher level instrumental activities of daily living by self-report
    • A total score ranging from 0 to 30, and a higher total score indicates having more difficulty performing daily activities

  6. Participation Objective, Participation Subjective (POPS)

    Time frame: Week 0 and Week 5

    • Measuring participation in activities of daily living by self-report
    • Participation Objective sub-scale score ranges from -3 (the least proportion, frequency, or hours) to +3 (the greatest proportion, frequency, or hours); Participation Subjective sub-scale score ranges from -4 (participating in the most important area, but wanting to engage either more or less) to +4 (participating in the most important area with satisfaction).

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

An Intervention for Cardiac Arrest Survivors With Chronic Fatigue: A Feasibility Study

Acronym: CAF

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 12, 2016
Registry last updated
Aug 12, 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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