CREATE-HF: CR: Developing an Intervention to Improve Acceptance of Referral in HF

Sponsor
University of Leicester (Other)
Overall Status
Recruiting
CT.gov ID
NCT04276675
Collaborator
British Heart Foundation (Other)
203
1
22.9
8.9

Study Details

Study Description

Brief 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. 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).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Trial Design: Mixed method approach to development of an intervention: observational cohort study, focus groups, staff survey, theory informed intervention development using 'The Behaviour Change Wheel'.

    Trial Participants:
    1. Patients admitted to hospital for an episode of decompensated HFrEF who have been referred to the Heart Failure Nursing Service (HFNS) and are eligible for referral for cardiac rehabilitation.

    2. Carers of patient participants

    3. 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; 50 participants in focus groups; 40 health care professionals

    Follow-up duration:

    Part 1 of the study: Observational Cohort: from discharge to 6 weeks post discharge; Part 2 of the study: Focus groups: participation in 1 focus group not before their 6 week follow up from observational study. Feedback on final proposed intervention. Carers: participate in one focus group not before patient's 6 week follow up visit. ; 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.

    Secondary Endpoints:

    Observational study: Uptake of referral to cardiac rehabilitation by patients following an episode of decompensated heart failure at 6 weeks post discharge.

    Focus groups and staff survey: Identify patient, carer 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.

    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 focus groups 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

    Study Type:
    Observational
    Anticipated Enrollment :
    203 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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.
    Actual Study Start Date :
    Feb 5, 2020
    Anticipated Primary Completion Date :
    Jan 1, 2022
    Anticipated Study Completion Date :
    Jan 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Acceptance of referral to cardiac rehabilitation [Pre-discharge]

      Identify whether participant has been referred to CR

    Secondary Outcome Measures

    1. Acceptance of referral to cardiac rehabilitation [6 weeks post discharge]

      Identify whether participant has been referred to CR

    Other Outcome Measures

    1. Identify patient, carer and health care professional perceived barriers and facilitators to referral to Cardiac Rehabilitation [18 months]

      Qualitative data analysis of focus groups and staff survey data to identify themes indicating what the barriers and facilitators to acceptance of referral to CR are.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Observational study:
    Inclusion Criteria:
    • Clinical diagnosis of HFrEF confirmed by cardiac imaging within 3 years.

    • 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

    Exclusion Criteria:
    • 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

    • Previous recruitment onto this study

    Focus groups:
    Inclusion criteria:

    Participants of the observational study and their carers

    Survey:
    Inclusion criteria:

    Health care professionals who refer to or deliver cardiac rehabilitation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Glenfield Hospital Leicester Leicestershire United Kingdom LE3 9QP

    Sponsors and Collaborators

    • University of Leicester
    • British Heart Foundation

    Investigators

    • Principal Investigator: Hannah Waterhouse, University of Leicester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Leicester
    ClinicalTrials.gov Identifier:
    NCT04276675
    Other Study ID Numbers:
    • 0739
    First Posted:
    Feb 19, 2020
    Last Update Posted:
    May 3, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 3, 2021