NCT05784272

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

March 13, 2023

Last Update Submit

March 11, 2024

Conditions

Keywords

CardiovascularRehabilitationUnderepresented groups

Outcome Measures

Primary Outcomes (1)

  • Questionnaires

    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 Outcomes (1)

  • Semi-structured interviews

    Within 2 weeks of return of the individual particiant's questionnaire response

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aneurin Bevan University Hospital

Caerleon, Gwent, NP18 3XQ, United Kingdom

NOT YET RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

Stockport NHS Foundation Trust

Stockport, SK2 7JE, United Kingdom

NOT YET RECRUITING

Related Publications (23)

  • BHF. UK statistics 2021.

    BACKGROUND
  • Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.

    PMID: 34741536BACKGROUND
  • Thomas RJ, King M, Lui K, Oldridge N, Pina IL, Spertus J; American Association of Cardiovascular and Pulmonary Rehabilitation/American College of Cardiology/American Heart Association Cardiac Rehabilitation/Secondary Prevention Performance Measures Writing Committee. AACVPR/ACC/AHA 2007 performance measures on cardiac rehabilitation for referral to and delivery of cardiac rehabilitation/secondary prevention services. Circulation. 2007 Oct 2;116(14):1611-42. doi: 10.1161/CIRCULATIONAHA.107.185734. Epub 2007 Sep 20. No abstract available.

    PMID: 17885210BACKGROUND
  • Thomas RJ, King M, Lui K, Oldridge N, Pina IL, Spertus J, Bonow RO, Estes NA 3rd, Goff DC, Grady KL, Hiniker AR, Masoudi FA, Radford MJ, Rumsfeld JS, Whitman GR; AACVPR; ACC; AHA; American College of Chest Physicians; American College of Sports Medicine; American Physical Therapy Association; Canadian Association of Cardiac Rehabilitation; European Association for Cardiovascular Prevention and Rehabilitation; Inter-American Heart Foundation; National Association of Clinical Nurse Specialists; Preventive Cardiovascular Nurses Association; Society of Thoracic Surgeons. AACVPR/ACC/AHA 2007 performance measures on cardiac rehabilitation for referral to and delivery of cardiac rehabilitation/secondary prevention services endorsed by the American College of Chest Physicians, American College of Sports Medicine, American Physical Therapy Association, Canadian Association of Cardiac Rehabilitation, European Association for Cardiovascular Prevention and Rehabilitation, Inter-American Heart Foundation, National Association of Clinical Nurse Specialists, Preventive Cardiovascular Nurses Association, and the Society of Thoracic Surgeons. J Am Coll Cardiol. 2007 Oct 2;50(14):1400-33. doi: 10.1016/j.jacc.2007.04.033. No abstract available.

    PMID: 17903645BACKGROUND
  • Squires RW, Montero-Gomez A, Allison TG, Thomas RJ. Long-term disease management of patients with coronary disease by cardiac rehabilitation program staff. J Cardiopulm Rehabil Prev. 2008 May-Jun;28(3):180-6; quiz 187-8. doi: 10.1097/01.HCR.0000320068.35728.12.

    PMID: 18496316BACKGROUND
  • Sandercock G, Hurtado V, Cardoso F. Changes in cardiorespiratory fitness in cardiac rehabilitation patients: a meta-analysis. Int J Cardiol. 2013 Aug 10;167(3):894-902. doi: 10.1016/j.ijcard.2011.11.068. Epub 2011 Dec 27.

    PMID: 22206636BACKGROUND
  • Taylor C, Tsakirides C, Moxon J, Moxon JW, Dudfield M, Witte K, Ingle L, Carroll S. Exercise dose and all-cause mortality within extended cardiac rehabilitation: a cohort study. Open Heart. 2017 Jul 28;4(2):e000623. doi: 10.1136/openhrt-2017-000623. eCollection 2017.

    PMID: 28878950BACKGROUND
  • NACR. Quality and Outcomes Report 2019.

    BACKGROUND
  • Ozemek C, Squires RW. Enrollment and Adherence to Early Outpatient and Maintenance Cardiac Rehabilitation Programs. J Cardiopulm Rehabil Prev. 2021 Nov 1;41(6):367-374. doi: 10.1097/HCR.0000000000000645.

    PMID: 34727555BACKGROUND
  • Brawner CA, Girdano D, Ehrman JK, Keteyian SJ. Association Between Phase 3 Cardiac Rehabilitation and Clinical Events. J Cardiopulm Rehabil Prev. 2017 Mar;37(2):111-118. doi: 10.1097/HCR.0000000000000201.

    PMID: 27676465BACKGROUND
  • Dohnke B, Nowossadeck E, Muller-Fahrnow W. Motivation and participation in a phase III cardiac rehabilitation programme: an application of the health action process approach. Res Sports Med. 2010 Oct;18(4):219-35. doi: 10.1080/15438627.2010.510032.

    PMID: 21058208BACKGROUND
  • American College of Sports Medicine. (2022). Guidelines for Exercise Testing and Prescription (G. Ligouri, Ed.; Eleventh). Wolters Kluwer.

    BACKGROUND
  • Beswick AD, Rees K, Griebsch I, Taylor FC, Burke M, West RR, Victory J, Brown J, Taylor RS, Ebrahim S. Provision, uptake and cost of cardiac rehabilitation programmes: improving services to under-represented groups. Health Technol Assess. 2004 Oct;8(41):iii-iv, ix-x, 1-152. doi: 10.3310/hta8410.

    PMID: 15461879BACKGROUND
  • Karmali KN, Davies P, Taylor F, Beswick A, Martin N, Ebrahim S. Promoting patient uptake and adherence in cardiac rehabilitation. Cochrane Database Syst Rev. 2014 Jun 25;(6):CD007131. doi: 10.1002/14651858.CD007131.pub3.

    PMID: 24963623BACKGROUND
  • Herber OR, Bucker B, Metzendorf MI, Barroso J. A qualitative meta-summary using Sandelowski and Barroso's method for integrating qualitative research to explore barriers and facilitators to self-care in heart failure patients. Eur J Cardiovasc Nurs. 2017 Dec;16(8):662-677. doi: 10.1177/1474515117711007. Epub 2017 May 16.

    PMID: 28509565BACKGROUND
  • Sparkes, A. C., & Smith, B. (2014). Qualitative research methods in sport, exercise and health: From process to product. Routledge/Taylor & Francis Group.

    BACKGROUND
  • QSR International Pty Ltd. (2020) NVivo (released in March 2020), https://www.qsrinternational.com/nvivo-qualitative-data-analysis-software/home

    BACKGROUND
  • Braun V, Clarke V. Novel insights into patients' life-worlds: the value of qualitative research. Lancet Psychiatry. 2019 Sep;6(9):720-721. doi: 10.1016/S2215-0366(19)30296-2. Epub 2019 Jul 23. No abstract available.

    PMID: 31350207BACKGROUND
  • Merriam, S. B., & Tisdell, E. J. (2016). Qualitative Research: A Guide to Design and Implementation (4th ed.). San Francisco, CA: Jossey Bass.

    BACKGROUND
  • Denzin, N. K. (1978). Triangulation: A Case for Methodological Evaluation and Combination. Sociological Methods, 339-357.

    BACKGROUND
  • Patton, M. Q. (2015). Qualitative research and evaluation methods: Theory and practice; Fourth Edition. In SAGE Publications, Inc.

    BACKGROUND
  • Ethnic diversity in politics and public life - House of Commons Library. (n.d.). Retrieved October 10, 2022, from https://commonslibrary.parliament.uk/research-briefings/sn01156/

    BACKGROUND
  • Ryba, T. V., Haapanen, S., Mosek, S., & Ng, K. (2012). Toward a conceptual understanding of acute cultural adaptation: A preliminary examination of ACA in female swimming. Qualitative Research in Sport, Exercise and Health, 4(1), 80-97. https://doi.org/10.1080/2159676X.2011.653498

    BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Stefan Birkett, PhD

CONTACT

Jay Railton-Sowerby, BSc (Hons)

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Cardiovascular Rehabilitation

Study Record Dates

First Submitted

March 13, 2023

First Posted

March 24, 2023

Study Start

March 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

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

Locations