CAF: An Intervention for Cardiac Arrest Survivors With Chronic Fatigue

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT02864719
Collaborator
(none)
18
1
51

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Energy Conservation+Problem Solving Therapy
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Intervention for Cardiac Arrest Survivors With Chronic Fatigue: A Feasibility Study
Study Start Date :
Jul 1, 2010
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Energy Conservation+Problem Solving Therapy

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.

Other: Energy Conservation+Problem Solving Therapy
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.

Outcome Measures

Primary Outcome Measures

  1. Number of people who completed their study participation [Week 5]

    Assessing the feasibility of recruitment and retention

  2. Number of participants who successfully identified and solved fatigue-related problems [Week 5]

    Assessing the feasibility of telephone intervention delivery

  3. Client Satisfaction Questionnaire - 8 [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 [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 Outcome Measures

  1. Modified Fatigue Impact Scale [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 [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 [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) [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 [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) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Pittsburgh

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Young J Kim, Research associate, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02864719
Other Study ID Numbers:
  • PRO09110375
First Posted:
Aug 12, 2016
Last Update Posted:
Aug 12, 2016
Last Verified:
Aug 1, 2016
Keywords provided by Young J Kim, Research associate, University of Pittsburgh
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2016