An Intervention for Cardiac Arrest Survivors With Chronic Fatigue

Not Applicable

Completed

• Conditions: Heart Arrest; Fatigue; Cardiac Arrest
• Interventions: Other: Energy Conservation+Problem Solving Therapy

• Registration Number: NCT02864719
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2014-07
• Study Completion: 2014-10
• Study First Submitted: 2016-05-06
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-09
• Last Update Submitted: 2016-08-09
• Study First Posted: 2016-08-12
• Last Update Posted: 2016-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Energy Conservation+Problem Solving Therapy	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.

Primary Outcome Measures

Name	Time	Method
Number of participants who successfully identified and solved fatigue-related problems	Week 5	Assessing the feasibility of telephone intervention delivery
Number of people who completed their study participation	Week 5	Assessing the feasibility of recruitment and retention
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
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

Secondary Outcome Measures

Name	Time	Method
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
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
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).
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.
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.
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