Determinants of Progression From Phase III to IV Cardiac Rehabilitation

March 11, 2024 updated by: Stefan Birkett, Manchester Metropolitan University

A Multi-centred Exploratory Study Investigating the Determinants of Progression From Phase III to Phase IV Cardiac Rehabilitation in Underrepresented Populations

This study will determine the limiting factors in progression from phase III to IV cardiac rehabilitation in underepresented populations (as defined by the National Audit of Cardiac Rehab, NACR). This will be done by recruiting participants from phase III cardiac rehab programmes and issuing questionnaires (either a non-initiator questionnire, or an initiator questionnaire based on if the participant is intiating into phase IV cardiac rehab. The questionnaires will assess reasons for/against progression as well as collecting some demographic and data indicative of socioeconomic status. Semi-structured interviews will then be conducted to assess reasons/barriers for progression to phase IV in a convenience sample of both initiators and non-initiators.

Study Overview

Status

Recruiting

Conditions

Detailed Description

In the United Kingdom (UK) >2.3 million people are living with coronary heart disease (CHD) (1). Cardiac rehabilitation (CR) is a core component of secondary prevention that reduces hospitalisations, cardiovascular mortality and improves quality of life (2). Traditionally, CR has four phases: Phase I (in-hospital), Phase II (early outpatient), Phase III (early CR typically 8-11 weeks in duration) and Phase IV, the long-term maintenance programme which aims to further build on the success of Phase III (3). As longer-term CR programmes (beyond 11 weeks) are associated with reductions in mortality, greater gains in fitness and improvement in risk factors (4-6), it is important that patients are encouraged to continue to take part in CR for as long as possible. Despite the associated benefits of CR, pre-Covid-19, only 50% of those eligible in the UK accessed Phase III (7) with this percentage further decreasing during the pandemic to 36%. A major concern was that there was a further reduction of 11% and 6% in ethnic minorities and female participation, two groups already significantly underrepresented in CR (7). Consequently, the most recent National Audit of Cardiac Rehabilitation (NACR) report (2021) stated that the development and implementation of strategies to halt the widening gap is a key priority. Data regarding uptake for long-term phase IV CR are limited (8).

Patient Identification Patients who are currently attending a Phase III cardiac rehabilitation programme at the aforementioned centres and who meet the inclusion criteria will be approached by members of the cardiac rehabilitation team at each site. If patients agree verbal and written information will be provided.

Consent The phase III CR team from each centre will explain what participating in this study would involve and give them a participant information sheet. The potential participant will then be given the opportunity to ask the phase III staff member and questions they may have. If the phase III staff member is not sure, the research team will be contacted, and clarification will be provided. Only those capable of giving informed consent will be eligible to participate. This includes being able to understand and communicate in English language well enough to give informed consent as no translation will be available in this study. Verbal and written informed consent to partake in the study and to be contacted by the research team will be attained at the patients Phase III discharge assessment by a member of the cardiac rehabilitation team. Institutional email addresses will be used to inform the research team of patients who have given informed consent (NHS email addresses from the rehabilitation team sending to Manchester Metropolitan University email addresses of the research team). The informed consent documents will be scanned and emailed to the research team and then the physical copies will be destroyed at the Trust's site. The research team will then hold these documents in a password protected folder on Manchester Metropolitan University's secure dropbox system. In compliance with the Welsh Language Act 1993, where participant information sheets and informed consent forms will be translated into Welsh where this is requested by a participant.

Study procedures At least one week prior to their Phase III discharge assessment, eligible patient will be given a patient information sheet. They will have the opportunity to ask any questions relating to the study. At their final phase III assessment, they will be asked if they would like to participate and informed consent and consent to contact will be obtained. Consented CR participants will be contacted by the research team and asked to complete a digital or paper form questionnaire based on their choice to initiate or not to initiate Phase IV CR. The questionnaires will aim to collect data in both quantitative (1-5 Likert scale style responses) and qualitative forms with questions including demographic and reasons for progressing or not progressing to phase IV CR. A convenience sample will be asked to complete a semi-structured interview over the phone or via Microsoft teams, which will last around 20 minutes.

An initiator will be defined as a participant who has attended at least three phase IV CR sessions, and a non-initiator defined as a participant who is either not going to do any exercise post phase III, or to exercise from home on their own. For this study, we will define phase IV CR as any referral to a long-term structured or unstructured maintenance programme of regular exercise/physical activity organised by a third part

The semi-structured interview approach will include core questions that we ask to each interviewee, flexible probing questions to encourage elaboration, and clarification questions that can be used in instances where a participant's answer is unclear. This semi-structured approach will allow individuals to discuss areas of perceived importance (15) whilst allowing us to collect data that are relevant to the research questions. The interviews will be conducted face-to-face when possible and appropriate or via Microsoft Teams® in situations where logistics or COVID precautions prevent in person discussions. Interviews will be recorded using a Dictaphone or the record function on Microsoft Teams®. Care will be taken to report enough information that allows the findings of the study to resonate with readers while protecting the participants' confidentiality.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All of those participating in phase III cardiac rehabilitation from underepresented populations

Description

Inclusion Criteria:

  • • Those participating in phase III cardiac rehabilitation and nearing successful completion of the programme

    • Subjects capable of giving informed consent
    • >18 years old
    • Clinically stable
    • Successful completion of an NHS commissioned hospital or community based phase III programme
    • Belong to one of the groups being investigated: Underrepresented groups based on the NACR report, i.e. females and ethnic minorities (defined as all people except those in the "White" ethnic group in Great Britain) (22)

Exclusion Criteria:

  • • Unstable/uncontrolled coronary heart disease

    • Those presenting with any significant comorbidities or contraindications to exercise testing or training in accordance with the American College of Sports Medicine (11)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Initiators
These will be the participants who initiate into phase IV cardiac reahb
Non-initiators
These will be the participants who do not initiate into phase IV cardiac reahb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaires
Time Frame: These will be distributed to participants approximately 2 weeks after Informed consent is obtained
The questionnaires issued to all participants, these will collect qualitative and quantitative data.
These will be distributed to participants approximately 2 weeks after Informed consent is obtained

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semi-structured interviews
Time Frame: Within 2 weeks of return of the individual particiant's questionnaire response
These will be informal conversations conducted in approximately 1/3 of all participants
Within 2 weeks of return of the individual particiant's questionnaire response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manchester Metropolitan University

Collaborators

British Heart Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS: 322092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared with other researchers outside of this project.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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