Heart ArrestCAFNCT02864719
An Intervention for Cardiac Arrest Survivors With Chronic Fatigue
A study testing Energy Conservation+Problem Solving Therapy in people with Heart Arrest and Cardiac Arrest, run by University of Pittsburgh.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest, Cardiac Arrest, Fatigue
- What is being tested?
- Energy Conservation+Problem Solving Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
About this study
Official title: An Intervention for Cardiac Arrest Survivors With Chronic Fatigue: A Feasibility Study
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.
- Conditions
- Heart Arrest, Cardiac Arrest, Fatigue
- Being tested
- Energy Conservation+Problem Solving Therapy
- Keywords
- Heart arrest, Cardiac arrest, Fatigue
- Medical subject headings
- Heart Arrest, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Energy Conservation+Problem Solving Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of people who completed their study participation
Assessing the feasibility of recruitment and retention
Measured: Week 5
Number of participants who successfully identified and solved fatigue-related problems
Assessing the feasibility of telephone intervention delivery
Measured: 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
Measured: 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
Measured: Week 5
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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).
Measured: Week 0 and Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startJul 2010
- Primary completionJul 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young J Kim, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864719
- Sponsor's protocol ID
- PRO09110375
- Acronym
- CAF
- Status last verified
- Aug 2016
- First submitted
- 6 May 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention for Cardiac Arrest Survivors With Chronic Fatigue: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02864719
- Acronym / sponsor ID
- CAF / PRO09110375
- Conditions
- Heart Arrest, Cardiac Arrest, Fatigue
- Keywords
- Heart arrest, Cardiac arrest, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Energy Conservation+Problem Solving Therapy | Experimental | Other: Energy Conservation+Problem Solving TherapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy Conservation+Problem Solving TherapyThe 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 |
Primary outcome
Number of people who completed their study participation
Time frame: Week 5
Assessing the feasibility of recruitment and retention
Number of participants who successfully identified and solved fatigue-related problems
Time frame: Week 5
Assessing the feasibility of telephone intervention delivery
Client Satisfaction Questionnaire - 8
Time frame: Week 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 Scale
Time frame: Week 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
6 secondary outcomes
Modified Fatigue Impact Scale
Time frame: Week 0 and Week 5
Fatigue Severity Scale
Time frame: Week 0 and Week 5
Patient-Reported Outcomes Measurement Information System Fatigue Scale
Time frame: Week 0 and Week 5
Performance Assessment of Self-Care Skills - Self-report (PASS-SR)
Time frame: Week 0 and Week 5
Functional Activities Questionnaire
Time frame: Week 0 and Week 5
Participation Objective, Participation Subjective (POPS)
Time frame: Week 0 and Week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Energy Conservation+Problem Solving Therapy in people with Heart Arrest and Cardiac Arrest, run by University of Pittsburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of people who completed their study participation (time frame: Week 5). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2016.