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临床试验/NCT04276675
NCT04276675已完成不适用

Cardiac Rehabilitation Programme in Patients Following Hospitalisation for Decompensated Chronic Heart Failure: the Development of an Intervention to Improve Patient Acceptance of Referral.

University of Leicester1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
Acceptance of referral to cardiac rehabilitation

研究概览

简要总结

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).

详细描述

Trial Design: Mixed method approach to development of an intervention: observational cohort study, semi-structured interviews, 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 heart failure who have been referred to the Heart Failure Nursing Service (HFNS) and are eligible for referral for cardiac rehabilitation.
  2. Patients who have been referred to cardiac rehabilitation from the HFNS, Cardiology outpatients and general practice.
  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; 8 to 40 participants in semi-structured interviews;10 to 15 health care professionals in focus groups; 40 health care professionals questionnaire

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of chronic heart failure confirmed by cardiac imaging.
  • 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

排除标准

  • 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
  • Semi-structured interviews: Purposive sampling
  • Inclusion criteria:
  • Patients with chronic heart failure who fulfil the criteria for referral to the cardiac rehabilitation service will be eligible to participate in the interviews if they are:
  • Age 18 years or over
  • Have a clinical diagnosis of CHF confirmed by cardiac imaging.
  • Referred to the acute trusts heart failure nursing service and/or cardiac rehabilitation team
  • 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 (See Appendix D) e.g. uncontrolled hypertension, severe aortic stenosis, unstable angina
  • Moderate to severe cognitive impairment
  • Nursing home resident
  • Significant co-morbidities that would limit participation in a cardiac rehabilitation programme e.g. neurodegenerative conditions
  • Previous recruitment onto this study
  • Focus groups: convenience sampling
  • Inclusion criteria:
  • Staff from study site who are involved in the provision of cardiac rehabilitation to people with heart failure will be eligible to participate in the focus group.
  • Survey: convenience sampling
  • Inclusion criteria:
  • Health care professionals who refer to or deliver cardiac rehabilitation.

结局指标

主要结局

Acceptance of referral to cardiac rehabilitation

时间窗: Within 7 days from baseline visit

Identify whether participant has been referred to CR

Qualitative evaluation of impact of offer of referral to cardiac rehabilitation service

时间窗: 6 weeks

Health care professionals offer referral to cardiac rehabilitation to people with heart failure as part of their ongoing treatment. Interviews and focus groups will be used to identify patient and health care professional perceived barriers and facilitators to the uptake of referral to cardiac rehabilitation by patients. Outcome measures from these cannot be counted and the data will be analysed using qualitative methods to identify themes representing the meanings associated with the participants' disclosures.

次要结局

  • Qualitative evaluation of impact of COVID 19 on acceptance of referral to cardiac rehabilitation service(6 weeks)
  • Acceptance of referral to cardiac rehabilitation(6 weeks post discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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