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An Intervention for Cardiac Arrest Survivors With Chronic Fatigue (CAF)

Primary Purpose

Heart Arrest, Cardiac Arrest, Fatigue

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Energy Conservation+Problem Solving Therapy
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Arrest focused on measuring Heart arrest, Cardiac arrest, Fatigue

Eligibility Criteria

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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Energy Conservation+Problem Solving Therapy

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Number of people who completed their study participation
    Assessing the feasibility of recruitment and retention
    Number of participants who successfully identified and solved fatigue-related problems
    Assessing the feasibility of telephone intervention delivery
    Client Satisfaction Questionnaire - 8
    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
    Understanding of Materials Scale
    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 Outcome Measures

    Modified Fatigue Impact Scale
    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
    Fatigue Severity Scale
    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.
    Patient-Reported Outcomes Measurement Information System Fatigue Scale
    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.
    Performance Assessment of Self-Care Skills - Self-report (PASS-SR)
    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
    Functional Activities Questionnaire
    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
    Participation Objective, Participation Subjective (POPS)
    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).

    Full Information

    First Posted
    May 6, 2016
    Last Updated
    August 9, 2016
    Sponsor
    University of Pittsburgh
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02864719
    Brief Title
    An Intervention for Cardiac Arrest Survivors With Chronic Fatigue
    Acronym
    CAF
    Official Title
    An Intervention for Cardiac Arrest Survivors With Chronic Fatigue: A Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2010 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pittsburgh

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Arrest, Cardiac Arrest, Fatigue
    Keywords
    Heart arrest, Cardiac arrest, Fatigue

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Energy Conservation+Problem Solving Therapy
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Energy Conservation+Problem Solving Therapy
    Intervention Description
    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 Outcome Measure Information:
    Title
    Number of people who completed their study participation
    Description
    Assessing the feasibility of recruitment and retention
    Time Frame
    Week 5
    Title
    Number of participants who successfully identified and solved fatigue-related problems
    Description
    Assessing the feasibility of telephone intervention delivery
    Time Frame
    Week 5
    Title
    Client Satisfaction Questionnaire - 8
    Description
    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
    Time Frame
    Week 5
    Title
    Understanding of Materials Scale
    Description
    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
    Time Frame
    Week 5
    Secondary Outcome Measure Information:
    Title
    Modified Fatigue Impact Scale
    Description
    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
    Time Frame
    Week 0 and Week 5
    Title
    Fatigue Severity Scale
    Description
    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.
    Time Frame
    Week 0 and Week 5
    Title
    Patient-Reported Outcomes Measurement Information System Fatigue Scale
    Description
    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.
    Time Frame
    Week 0 and Week 5
    Title
    Performance Assessment of Self-Care Skills - Self-report (PASS-SR)
    Description
    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
    Time Frame
    Week 0 and Week 5
    Title
    Functional Activities Questionnaire
    Description
    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
    Time Frame
    Week 0 and Week 5
    Title
    Participation Objective, Participation Subjective (POPS)
    Description
    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).
    Time Frame
    Week 0 and Week 5

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    An Intervention for Cardiac Arrest Survivors With Chronic Fatigue

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