Clinical trial NCT05784272: Determinants of Progression From Phase III to IV Cardiac Rehabilitation
Official title: A Multi-centred Exploratory Study Investigating the Determinants of Progression From Phase III to Phase IV Cardiac Rehabilitation in Underrepresented Populations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Keywords: Cardiovascular
Rehabilitation
Underepresented groups
Lead sponsor: Manchester Metropolitan University
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2023-03-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All of those participating in phase III cardiac rehabilitation from underepresented populations

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Questionnaires
timeFrame: These will be distributed to participants approximately 2 weeks after Informed consent is obtained
Secondary outcomes:
measure: Semi-structured interviews
timeFrame: Within 2 weeks of return of the individual particiant's questionnaire response
Other outcomes:
Locations:
city: Caerleon
country: United Kingdom
facility: Aneurin Bevan University Hospital
state: Gwent
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Stockport
country: United Kingdom
facility: Stockport NHS Foundation Trust
Study officials:
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