Heart FailureNCT03820674
A Telerehabilitation Intervention for People With Heart Failure and Chronic Fatigue
A study testing Energy Conservation plus Problem Solving Therapy and Health Education Intervention in people with Heart Failure, run by East Carolina University.
Trial summary
This study compares the effectiveness of a 6-week Energy Conservation + Problem Solving Therapy Intervention to Health Education Intervention for reducing the fatigue impact and fatigue level and improving the level of participation in instrumental, leisure, and social activities in people with heart failure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Energy Conservation plus Problem Solving Therapy and Health Education Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 17 Jun 2016to 1 May 2019
- 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
- a minimum 6 months since diagnosed with HF and 3 months post-hospitalization, (b) reporting of moderate to severe fatigue by scoring ≥4 according to Fatigue Severity Scale, (c) living in the community, (d) having access to the internet or telephone in the place of residence, (e) having functional English fluency, and (f) having functional vision to operate the tablet computer.
Who cannot join
- had a score of ≥9 in Short Blessed Test indicating cognitive impairment
- were classified as having New York Heart Association (NYHA) Functional Classification level IV on their medical record
About this study
Official title: A Telerehabilitation Intervention to Reduce the Impact of Fatigue in People With Congestive Heart Failure and Chronic Fatigue
This study compares the effectiveness of a 6-week Energy Conservation + Problem Solving Therapy Intervention to Health Education Intervention for reducing the fatigue impact and fatigue level and improving the level of participation in instrumental, leisure, and social activities in people with heart failure associated fatigue. Half of the participants received Energy Conservation + Problem Solving Therapy Intervention, and the other half received Health Education Intervention.
Read the detailed description
Energy Conservation+Problem Solving Therapy (EC+PST) Intervention: In this study, the EC+PST Intervention will ideally occur twice a week for 6 weeks with each session lasting approximately 30 minutes. The intervention will be individually delivered via telehealth; therefore, participants will receive the intervention in their home to minimize fatigue from the intervention.
Health Education Intervention: The Health Education Intervention will occur once a week for 6 weeks with each session lasting approximately 30 minutes. The Health Education Intervention will be delivered via telehealth; therefore, participants will receive the intervention at their convenient quiet place to minimize fatigue from the intervention.
- Conditions
- Heart Failure
- Being tested
- Energy Conservation plus Problem Solving Therapy, Health Education Intervention
- Keywords
- Heart Failure, Fatigue, Rehabilitation, Occupational Therapy
- Medical subject headings
- Heart Failure, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy Conservation plus Problem Solving TherapyOther
EC-PST is a client-centered intervention aiming to guide people with chronic fatigue to create their own solutions so that they can generalize those learned solutions and strategies to other fatigue-related problems even after completing the study participation. Some of the topics covered during the first two introductory sessions are facts regarding fatigue, budgeting and banking energy, and the introduction of EC+PST Intervention.
Health Education InterventionOther
The interventionist will be the PI, an occupational therapist (co-I), or OT graduate student who will be trained in the health education topics. During the Health Education sessions, participants will be educated on health-related topics relevant to CHF and EC strategies, although they will not learn how to apply the information to their daily life. Health Education Workbook containing information on the topics taught during the sessions will be provided during the Pretest visit and used throughout the Health Education sessions.
| Study group | Role | What they receive |
|---|---|---|
| Energy Conservation plus Problem Solving Therapy Intervention | Experimental | Receiving experimental intervention Receives: Other: Energy Conservation plus Problem Solving Therapy |
| Health Education Intervention | Active comparator | Receiving control intervention Receives: Other: Health Education Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Fatigue Impact Scale (FIS)
The FIS is a 40-item measure that assesses the impact of fatigue on daily life in three different dimensions: Cognitive (10 items), Physical (10 items), and Psychosocial functioning (20 items). Each item is rated on a 5-point scale ranging from 0 (no problem) to 4 (extreme problem), and the global score is the sum of 40 items, ranging from 0 to 160.
Measured: Pretest (Week 0), Posttest (Week 7)
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form Ver 1.0 Fatigue 8a
The PROMIS Fatigue 8a is a test measuring the experience and impact of fatigue. This assessment consists of 8 questions on fatigue experience and impact, and the raw score is converted to T-score (50% is the mean of the population). Higher the T-score, worse the fatigue.
Measured: Pretest (Week 0), Posttest (Week 7)
Changes in Activity Card Sort (ACS)
The ACS is a measure of the participation level in instrumental, leisure, and social activities. The ACS uses 89 photographs to calculate the percentage of retained activities since their diagnosis
Measured: Pretest (Week 0), Posttest (Week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start17 Jun 2016
- Primary completion2 May 2018
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both groups received 6-week interventions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Joo Kim, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820674
- Sponsor's protocol ID
- UMCIRB 16-000078
- Status last verified
- Jan 2020
- First submitted
- 24 Jan 2019
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim YJ, Radloff JC, Crane PA, Bolin LP. Rehabilitation Intervention for Individuals With Heart Failure and Fatigue to Reduce Fatigue Impact: A Feasibility Study. Ann Rehabil Med. 2019 Dec;43(6):686-699. doi: 10.5535/arm.2019.43.6.686. Epub 2019 Dec 31.
PubMed 31918531
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Telerehabilitation Intervention to Reduce the Impact of Fatigue in People With Congestive Heart Failure and Chronic Fatigue
- ClinicalTrials.gov ID
- NCT03820674
- Acronym / sponsor ID
- UMCIRB 16-000078
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Fatigue, Rehabilitation, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 17 Jun 2016 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 29 Jan 2019 (actual)
- 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.
This study compares the effectiveness of a 6-week Energy Conservation + Problem Solving Therapy Intervention to Health Education Intervention for reducing the fatigue impact and fatigue level and improving the level of participation in instrumental, leisure, and social activities in people with heart failure associated fatigue. Half of the participants received Energy Conservation + Problem Solving Therapy Intervention, and the other half received Health Education Intervention.
Detailed description
Energy Conservation+Problem Solving Therapy (EC+PST) Intervention: In this study, the EC+PST Intervention will ideally occur twice a week for 6 weeks with each session lasting approximately 30 minutes. The intervention will be individually delivered via telehealth; therefore, participants will receive the intervention in their home to minimize fatigue from the intervention.
Health Education Intervention: The Health Education Intervention will occur once a week for 6 weeks with each session lasting approximately 30 minutes. The Health Education Intervention will be delivered via telehealth; therefore, participants will receive the intervention at their convenient quiet place to minimize fatigue from the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Both groups received 6-week interventions.
| Arm | Type | Receives |
|---|---|---|
| Energy Conservation plus Problem Solving Therapy Intervention | Experimental | Other: Energy Conservation plus Problem Solving TherapyReceiving experimental intervention |
| Health Education Intervention | Active comparator | Other: Health Education InterventionReceiving control intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- a minimum 6 months since diagnosed with HF and 3 months post-hospitalization, (b) reporting of moderate to severe fatigue by scoring ≥4 according to Fatigue Severity Scale, (c) living in the community, (d) having access to the internet or telephone in the place of residence, (e) having functional English fluency, and (f) having functional vision to operate the tablet computer.
Key exclusion criteria (2 listed)
- had a score of ≥9 in Short Blessed Test indicating cognitive impairment
- were classified as having New York Heart Association (NYHA) Functional Classification level IV on their medical record
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 plus Problem Solving TherapyEC-PST is a client-centered intervention aiming to guide people with chronic fatigue to create their own solutions so that they can generalize those learned solutions and strategies to other fatigue-related problems even after completing the study participation. Some of the topics covered during the first two introductory sessions are facts regarding fatigue, budgeting and banking energy, and the introduction of EC+PST Intervention. | Other | Energy Conservation plus Problem Solving Therapy Intervention |
| Health Education InterventionThe interventionist will be the PI, an occupational therapist (co-I), or OT graduate student who will be trained in the health education topics. During the Health Education sessions, participants will be educated on health-related topics relevant to CHF and EC strategies, although they will not learn how to apply the information to their daily life. Health Education Workbook containing information on the topics taught during the sessions will be provided during the Pretest visit and used throughout the Health Education sessions. | Other | Health Education Intervention |
Primary outcome
Changes in Fatigue Impact Scale (FIS)
Time frame: Pretest (Week 0), Posttest (Week 7)
The FIS is a 40-item measure that assesses the impact of fatigue on daily life in three different dimensions: Cognitive (10 items), Physical (10 items), and Psychosocial functioning (20 items). Each item is rated on a 5-point scale ranging from 0 (no problem) to 4 (extreme problem), and the global score is the sum of 40 items, ranging from 0 to 160.
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form Ver 1.0 Fatigue 8a
Time frame: Pretest (Week 0), Posttest (Week 7)
The PROMIS Fatigue 8a is a test measuring the experience and impact of fatigue. This assessment consists of 8 questions on fatigue experience and impact, and the raw score is converted to T-score (50% is the mean of the population). Higher the T-score, worse the fatigue.
Changes in Activity Card Sort (ACS)
Time frame: Pretest (Week 0), Posttest (Week 7)
The ACS is a measure of the participation level in instrumental, leisure, and social activities. The ACS uses 89 photographs to calculate the percentage of retained activities since their diagnosis
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 29 Jan 2020.
- Derived from this study: PubMed 31918531Kim YJ, Radloff JC, Crane PA, Bolin LP. Rehabilitation Intervention for Individuals With Heart Failure and Fatigue to Reduce Fatigue Impact: A Feasibility Study. Ann Rehabil Med. 2019 Dec;43(6):686-699. doi: 10.5535/arm.2019.43.6.686. Epub 2019 Dec 31.
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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 plus Problem Solving Therapy and Health Education Intervention in people with Heart Failure, run by East Carolina University.
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 1 inclusion and 2 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 29 Jan 2020. 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?
Changes in Fatigue Impact Scale (FIS) (time frame: Pretest (Week 0), Posttest (Week 7)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03820674, which also lists 1 linked publication.
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 29 Jan 2020.