Determinants of Progression From Phase III to IV Cardiac Rehabilitation

Sponsor

Manchester Metropolitan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05784272

Collaborator

British Heart Foundation (Other)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases

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 Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Questionnaires [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.

Secondary Outcome Measures

Semi-structured interviews [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aneurin Bevan University Hospital	Caerleon	Gwent	United Kingdom	NP18 3XQ
2	Leeds Teaching Hospitals NHS Trust	Leeds		United Kingdom	LS9 7TF
3	Stockport NHS Foundation Trust	Stockport		United Kingdom	SK2 7JE

Sponsors and Collaborators

Manchester Metropolitan University
British Heart Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Stefan Birkett, Senior Lecturer in Cardiovascular Rehabilitation, Manchester Metropolitan University

ClinicalTrials.gov Identifier:

NCT05784272

Other Study ID Numbers:

IRAS: 322092

First Posted:

Mar 24, 2023

Last Update Posted:

Mar 24, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Stefan Birkett, Senior Lecturer in Cardiovascular Rehabilitation, Manchester Metropolitan University

Cardiovascular

Rehabilitation

Underepresented groups

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Mar 24, 2023