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CompletedNCT02864719CAFUpdated Aug 12, 2016

An Intervention for Cardiac Arrest Survivors With Chronic Fatigue

An interventional study of Energy Conservation+Problem Solving Therapy in Heart Arrest, Cardiac Arrest and Fatigue, sponsored by University of Pittsburgh. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-12.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Arrest
  • Cardiac Arrest
  • Fatigue

Keywords

  • Heart arrest
  • Cardiac arrest
  • Fatigue
03

In context

Heart Arrest

966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's enrollment of 18 is below the median of 100 across 557 interventional studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • 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

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.

06

What researchers measure

Primary outcomes

  1. Number of people who completed their study participation

    Assessing the feasibility of recruitment and retention

    Time frame: Week 5

  2. Number of participants who successfully identified and solved fatigue-related problems

    Assessing the feasibility of telephone intervention delivery

    Time frame: Week 5

  3. 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

    Time frame: Week 5

  4. 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

    Time frame: Week 5

Secondary outcomes

  1. 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

    Time frame: Week 0 and Week 5

  2. 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.

    Time frame: Week 0 and Week 5

  3. 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.

    Time frame: Week 0 and Week 5

  4. 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

    Time frame: Week 0 and Week 5

  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

    Time frame: Week 0 and Week 5

  6. 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).

    Time frame: Week 0 and Week 5

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02864719
Lead sponsor
University of Pittsburgh
Responsible party
Young J Kim (Research associate, University of Pittsburgh) — Principal investigator
First posted
Aug 12, 2016
Start date
Jul 2010
Primary completion
Jul 2014
Completion
Oct 2014
Last update
Aug 12, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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