NCT02864719

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
Last Updated

August 12, 2016

Status Verified

August 1, 2016

Enrollment Period

4 years

First QC Date

May 6, 2016

Last Update Submit

August 9, 2016

Conditions

Heart ArrestCardiac ArrestFatigue

Keywords

Heart arrestCardiac arrestFatigue

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • Modified Fatigue Impact Scale

    Week 0 and Week 5

  • Fatigue Severity Scale

    Week 0 and Week 5

  • Patient-Reported Outcomes Measurement Information System Fatigue Scale

    Week 0 and Week 5

  • Performance Assessment of Self-Care Skills - Self-report (PASS-SR)

    Week 0 and Week 5

  • Functional Activities Questionnaire

    Week 0 and Week 5

  • +1 more secondary outcomes

Study Arms (1)

Energy Conservation+Problem Solving Therapy

EXPERIMENTAL

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

Interventions

Energy Conservation+Problem Solving TherapyOTHER

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.

Energy Conservation+Problem Solving Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart ArrestFatigue

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research associate

Study Record Dates

First Submitted

May 6, 2016

First Posted

August 12, 2016

Study Start

July 1, 2010

Primary Completion

July 1, 2014

Study Completion

October 1, 2014

Last Updated

August 12, 2016

Record last verified: 2016-08