An Intervention for Cardiac Arrest Survivors With Chronic Fatigue

Fatigue Clinical Trial

— CAF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864719
• Other study ID #: PRO09110375
• Status: Completed
• Phase: N/A
• First received: May 6, 2016
• Last updated: August 9, 2016
• Start date: July 2010
• Est. completion date: October 2014

Study information

• Verified date: August 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Fatigue
• Heart Arrest

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of people who completed their study participation	Assessing the feasibility of recruitment and retention	Week 5	No
Primary	Number of participants who successfully identified and solved fatigue-related problems	Assessing the feasibility of telephone intervention delivery	Week 5	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No