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

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

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.

Study Overview

• Status: Completed
• Conditions: Fatigue; Heart Arrest; Cardiac Arrest
• Intervention / Treatment: Other: Energy Conservation+Problem Solving Therapy

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Week 0 and Week 5
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.	Week 0 and Week 5
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.	Week 0 and Week 5
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	Week 0 and Week 5
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	Week 0 and Week 5
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).	Week 0 and Week 5

Collaborators and Investigators

• Sponsor: University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimate): August 12, 2016

Study Record Updates

• Last Update Posted (Estimate): August 12, 2016
• Last Update Submitted That Met QC Criteria: August 9, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Fatigue; Cardiac arrest; Heart arrest
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Fatigue; Heart Arrest
• Other Study ID Numbers: PRO09110375