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An Intervention for Cardiac Arrest Survivors With Chronic Fatigue

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02864719
Acronym
CAF
Enrollment
18
Registered
2016-08-12
Start date
2010-07-31
Completion date
2014-10-31
Last updated
2016-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Fatigue, Heart Arrest

Keywords

Heart arrest, Cardiac arrest, Fatigue

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.

Interventions

OTHEREnergy 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.

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Number of people who completed their study participationWeek 5Assessing the feasibility of recruitment and retention
Number of participants who successfully identified and solved fatigue-related problemsWeek 5Assessing the feasibility of telephone intervention delivery
Client Satisfaction Questionnaire - 8Week 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
Understanding of Materials ScaleWeek 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

MeasureTime frameDescription
Functional Activities QuestionnaireWeek 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 ScaleWeek 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 ScaleWeek 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 ScaleWeek 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026