Heart FailureCREATE-HFNCT04276675
CR: Developing an Intervention to Improve Acceptance of Referral in HF
An observational study of Heart Failure and Frailty, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Background: There are proven benefits to people with chronic heart failure (CHF) participating in a cardiac rehabilitation (CR) programme, however uptake remains disappointingly low. Admission to hospital presents a significant opportunity to offer CR referral to such a patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Frailty
- How many people
- 68 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Feb 2020to 1 Nov 2022
- Phase
- Observational
- 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
Study population: Observational cohort: All patients admitted to the participating hospital with an episode of decompensated chronic heart failure and referred to the Heart Failure Nursing Service (HFNS) who are eligible for referral to cardiac rehabilitation. Semi-structured interviews: Participants of observational study; people with heart failure eligible for CR and referred to either the acute trust's heart failure nursing service and/ or cardiac rehabilitation team. Survey: Health care professionals involved in delivering or referring to cardiac rehabilitation to people with chronic heart failure.
Who may be able to join
- Clinical diagnosis of chronic heart failure confirmed by cardiac imaging.
- Current admission for which the primary reason was decompensated heart failure requiring IV diuretics
- Referred to the acute trusts heart failure nursing service
- Able to give informed consent
- Able to communicate in spoken English
- Patients with chronic heart failure who fulfil the criteria for referral to the cardiac rehabilitation service will be eligible to participate in the interviews if they are:
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- Age 18 years or over
- Have a clinical diagnosis of CHF confirmed by cardiac imaging.
- Referred to the acute trusts heart failure nursing service and/or cardiac rehabilitation team
- Able to give informed consent
- Able to communicate in spoken English
- Staff from study site who are involved in the provision of cardiac rehabilitation to people with heart failure will be eligible to participate in the focus group.
- Survey: convenience sampling
- Health care professionals who refer to or deliver cardiac rehabilitation.
Who cannot join
- Contraindications to participating in cardiac rehabilitation as detailed in ESC consensus statement e.g. uncontrolled hypertension severe aortic stenosis, unstable angina
- Moderate to severe cognitive impairment
- Patients with severe dependence prior to index admission (inability to carry out ADL)
- Admitted from a nursing home
- Resident 'out of area'
- Significant co-morbidities that would limit participation in a cardiac rehabilitation programme e.g. neurodegenerative conditions
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- Previous recruitment onto this study
- Semi-structured interviews: Purposive sampling
- Contraindications to participating in cardiac rehabilitation as detailed in ESC consensus statement (See Appendix D) e.g. uncontrolled hypertension, severe aortic stenosis, unstable angina
- Moderate to severe cognitive impairment
- Nursing home resident
- Significant co-morbidities that would limit participation in a cardiac rehabilitation programme e.g. neurodegenerative conditions
- Previous recruitment onto this study
- Focus groups: convenience sampling
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Glenfield Hospital
Leicester, Leicestershire, LE3 9QP
About this study
Official title: Cardiac Rehabilitation Programme in Patients Following Hospitalisation for Decompensated Chronic Heart Failure: the Development of an Intervention to Improve Patient Acceptance of Referral.
Background: There are proven benefits to people with chronic heart failure (CHF) participating in a cardiac rehabilitation (CR) programme, however uptake remains disappointingly low. Admission to hospital presents a significant opportunity to offer CR referral to such a patient population. It is believed that up to 75% of patients with CHF show signs of frailty at discharge which might impact on the rate of patients' acceptance of referral to CR.
Aim: To explore the impact of frailty on patient acceptance of referral to CR following admission to hospital with an episode of decompensated CHF.
Methods and expected outcome: We will conduct an observational study assessing the relationship between frailty and acceptance of referral to CR in this patient population. It will also explore what factors impact that relationship including demographic factors, measures of self-care and patient activation measure (PAM).
Read the detailed description
Trial Design: Mixed method approach to development of an intervention: observational cohort study, semi-structured interviews, focus groups, staff survey, theory informed intervention development using 'The Behaviour Change Wheel'.
Trial Participants:
- Patients admitted to hospital for an episode of decompensated heart failure who have been referred to the Heart Failure Nursing Service (HFNS) and are eligible for referral for cardiac rehabilitation.
- Patients who have been referred to cardiac rehabilitation from the HFNS, Cardiology outpatients and general practice.
- Health care professionals involved in the referral to or provision of cardiac rehabilitation services for people with chronic heart failure
Planned Sample Size:
203 patients in observational study; 8 to 40 participants in semi-structured interviews;10 to 15 health care professionals in focus groups; 40 health care professionals questionnaire
Follow-up duration:
Part 1 of the study: Observational Cohort: from discharge to 6 weeks post discharge; Part 2 of the study: Semi-structured interviews: participants have single semi-structured interview and given the opportunity to feedback on final proposed intervention Focus groups: cardiac rehabilitation team health care professionals participate in one focus group and feedback on final proposed intervention. Part 3 of study: Health care professional: single participation in survey and subgroup of HCP feedback on final proposed intervention
Planned Trial Period 24 months (including feasibility study of intervention)
Primary Objective: The primary objective of this study is to determine the key modifiable patient related factors associated with the acceptance of referral to cardiac rehabilitation in patients post discharge following an episode of decompensated chronic heart failure.
Secondary Objectives: Using the Behaviour Change wheel synthesize the data from the observational study, stakeholder perspectives and the literature on behaviour change interventions, develop a theory based intervention to increase the uptake of referral to cardiac rehabilitation in patients post discharge following an episode of decompensated chronic heart failure.
Primary Endpoint:
Observational study: Uptake of referral to cardiac rehabilitation by patients following an episode of decompensated heart failure at baseline visit.
Semi-structured interviews, focus groups and staff survey: Identify patient, and health care professional perceived barriers and facilitators to the uptake of referral to cardiac rehabilitation by patients following an episode of decompensated heart failure.
Secondary Endpoints:
Observational study: Uptake of referral to cardiac rehabilitation by patients following an episode of decompensated heart failure at 6 weeks post discharge.
Semi-structured interviews, focus groups and staff survey: Identify the impact of COVID 19 pandemic on the uptake of referral and participation in cardiac rehabilitation by patients following an episode of decompensated heart failure.
In consultation with experts in theory based interventions, data from all steps of the programme of study will be used to develop an intervention aimed at improving rate of acceptance of referral to CR in this patient population.
Further stakeholder involvement The intervention will be presented back in written form to interviewees and focus group members for further comment either written or via telephone contact. Health care professionals (HFNS team and CR team) will be invited for feedback on expected effectiveness and acceptability following which further adaptation of the intervention may occur
- Conditions
- Heart Failure, Frailty
- Medical subject headings
- Heart Failure, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of referral to cardiac rehabilitation
Identify whether participant has been referred to CR
Measured: Within 7 days from baseline visit
Qualitative evaluation of impact of offer of referral to cardiac rehabilitation service
Health care professionals offer referral to cardiac rehabilitation to people with heart failure as part of their ongoing treatment. Interviews and focus groups will be used to identify patient and health care professional perceived barriers and facilitators to the uptake of referral to cardiac rehabilitation by patients. Outcome measures from these cannot be counted and the data will be analysed using qualitative methods to identify themes representing the meanings associated with the participants' disclosures.
Measured: 6 weeks
Secondary outcomes (2)
Acceptance of referral to cardiac rehabilitation
Identify whether participant has been referred to CR
Measured: 6 weeks post discharge
Qualitative evaluation of impact of COVID 19 on acceptance of referral to cardiac rehabilitation service
This study was recruiting during the COVID 19 pandemic. Interviews and focus groups will be used to identify the impact of COVID 19 on the uptake of referral to cardiac rehabilitation by people with heart failure. Outcome measures from these cannot be counted and data will be analysed using qualitative methods to identify themes representing meanings associated with participants' disclosures.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start5 Feb 2020
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Hannah Waterhouse, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276675
- Sponsor's protocol ID
- 0739
- Acronym
- CREATE-HF
- Status last verified
- May 2022
- First submitted
- 11 Feb 2020
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rehabilitation Programme in Patients Following Hospitalisation for Decompensated Chronic Heart Failure: the Development of an Intervention to Improve Patient Acceptance of Referral.
- ClinicalTrials.gov ID
- NCT04276675
- Acronym / sponsor ID
- CREATE-HF / 0739
- Conditions
- Heart Failure, Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 19 Feb 2020 (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.
Background: There are proven benefits to people with chronic heart failure (CHF) participating in a cardiac rehabilitation (CR) programme, however uptake remains disappointingly low. Admission to hospital presents a significant opportunity to offer CR referral to such a patient population. It is believed that up to 75% of patients with CHF show signs of frailty at discharge which might impact on the rate of patients' acceptance of referral to CR.
Aim: To explore the impact of frailty on patient acceptance of referral to CR following admission to hospital with an episode of decompensated CHF.
Methods and expected outcome: We will conduct an observational study assessing the relationship between frailty and acceptance of referral to CR in this patient population. It will also explore what factors impact that relationship including demographic factors, measures of self-care and patient activation measure (PAM).
Detailed description
Trial Design: Mixed method approach to development of an intervention: observational cohort study, semi-structured interviews, focus groups, staff survey, theory informed intervention development using 'The Behaviour Change Wheel'.
Trial Participants:
- Patients admitted to hospital for an episode of decompensated heart failure who have been referred to the Heart Failure Nursing Service (HFNS) and are eligible for referral for cardiac rehabilitation.
- Patients who have been referred to cardiac rehabilitation from the HFNS, Cardiology outpatients and general practice.
- Health care professionals involved in the referral to or provision of cardiac rehabilitation services for people with chronic heart failure
Planned Sample Size:
203 patients in observational study; 8 to 40 participants in semi-structured interviews;10 to 15 health care professionals in focus groups; 40 health care professionals questionnaire
Follow-up duration:
Part 1 of the study: Observational Cohort: from discharge to 6 weeks post discharge; Part 2 of the study: Semi-structured interviews: participants have single semi-structured interview and given the opportunity to feedback on final proposed intervention Focus groups: cardiac rehabilitation team health care professionals participate in one focus group and feedback on final proposed intervention. Part 3 of study: Health care professional: single participation in survey and subgroup of HCP feedback on final proposed intervention
Planned Trial Period 24 months (including feasibility study of intervention)
Primary Objective: The primary objective of this study is to determine the key modifiable patient related factors associated with the acceptance of referral to cardiac rehabilitation in patients post discharge following an episode of decompensated chronic heart failure.
Secondary Objectives: Using the Behaviour Change wheel synthesize the data from the observational study, stakeholder perspectives and the literature on behaviour change interventions, develop a theory based intervention to increase the uptake of referral to cardiac rehabilitation in patients post discharge following an episode of decompensated chronic heart failure.
Primary Endpoint:
Observational study: Uptake of referral to cardiac rehabilitation by patients following an episode of decompensated heart failure at baseline visit.
Semi-structured interviews, focus groups and staff survey: Identify patient, and health care professional perceived barriers and facilitators to the uptake of referral to cardiac rehabilitation by patients following an episode of decompensated heart failure.
Secondary Endpoints:
Observational study: Uptake of referral to cardiac rehabilitation by patients following an episode of decompensated heart failure at 6 weeks post discharge.
Semi-structured interviews, focus groups and staff survey: Identify the impact of COVID 19 pandemic on the uptake of referral and participation in cardiac rehabilitation by patients following an episode of decompensated heart failure.
In consultation with experts in theory based interventions, data from all steps of the programme of study will be used to develop an intervention aimed at improving rate of acceptance of referral to CR in this patient population.
Further stakeholder involvement The intervention will be presented back in written form to interviewees and focus group members for further comment either written or via telephone contact. Health care professionals (HFNS team and CR team) will be invited for feedback on expected effectiveness and acceptability following which further adaptation of the intervention may occur
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Observational cohort: All patients admitted to the participating hospital with an episode of decompensated chronic heart failure and referred to the Heart Failure Nursing Service (HFNS) who are eligible for referral to cardiac rehabilitation. Semi-structured interviews: Participants of observational study; people with heart failure eligible for CR and referred to either the acute trust's heart failure nursing service and/ or cardiac rehabilitation team. Survey: Health care professionals involved in delivering or referring to cardiac rehabilitation to people with chronic heart failure.
Key inclusion criteria (14 listed)
- Clinical diagnosis of chronic heart failure confirmed by cardiac imaging.
- Current admission for which the primary reason was decompensated heart failure requiring IV diuretics
- Referred to the acute trusts heart failure nursing service
- Able to give informed consent
- Able to communicate in spoken English
Key exclusion criteria (14 listed)
- Contraindications to participating in cardiac rehabilitation as detailed in ESC consensus statement e.g. uncontrolled hypertension severe aortic stenosis, unstable angina
- Moderate to severe cognitive impairment
- Patients with severe dependence prior to index admission (inability to carry out ADL)
- Admitted from a nursing home
- Resident 'out of area'
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acceptance of referral to cardiac rehabilitation
Time frame: Within 7 days from baseline visit
Identify whether participant has been referred to CR
Qualitative evaluation of impact of offer of referral to cardiac rehabilitation service
Time frame: 6 weeks
Health care professionals offer referral to cardiac rehabilitation to people with heart failure as part of their ongoing treatment. Interviews and focus groups will be used to identify patient and health care professional perceived barriers and facilitators to the uptake of referral to cardiac rehabilitation by patients. Outcome measures from these cannot be counted and the data will be analysed using qualitative methods to identify themes representing the meanings associated with the participants' disclosures.
2 secondary outcomes
Acceptance of referral to cardiac rehabilitation
Time frame: 6 weeks post discharge
Qualitative evaluation of impact of COVID 19 on acceptance of referral to cardiac rehabilitation service
Time frame: 6 weeks
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 15 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
Hannah Waterhouse principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Frailty, run by University of Leicester at 1 site in United Kingdom.
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 14 inclusion and 14 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 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Acceptance of referral to cardiac rehabilitation (time frame: Within 7 days from baseline visit). The study lists 2 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 15 Sep 2023.