An Intervention for Cardiac Arrest Survivors With Chronic Fatigue

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Arrest, Cardiac Arrest, Fatigue

Intervention / Treatment
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* Other: Energy Conservation+Problem Solving Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Energy Conservation+Problem Solving Therapy<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Heart arrest, Cardiac arrest