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临床试验/NCT04781699
NCT04781699Unknown不适用

Optimising Secondary Prevention and Quality of Life in Early Cardiac Rehabilitation

Sheffield Hallam University6 个研究点 分布在 1 个国家目标入组 498 人开始时间: 2021年3月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
498
试验地点
6
主要终点
Reasons people attend early cardiac rehabilitation (quantitative method).

研究概览

简要总结

The primary aim of this research is to explore the adherence and drop-out from early cardiac rehabilitation (CR), to inform interventions to support patient's adherence to CR and facilitate maintenance. The secondary aim is to understand which aspects of CR are essential for improving health-related quality of life in the short and long-term. This research will comprise four stages adopting a mixed-methods, quasi-experimental, repeated measures design.

详细描述

This study will explore the attitudes of patients and healthcare practitioners towards the components of CR (diet, smoking, and medication) and their relationship with improving patients' perceived health and wellbeing. We will apply user-centred approaches by working with patients and other stakeholders to develop the best solutions that help patients to adhere to relevant health behaviour changes. The proposed study will use a mix of surveys and interviews. This will conclude with a two-day workshop with patients and health care professionals to come up with recommendations for improving adherence to CR.

Stage 1: A bespoke survey has been designed to examine the perceptions of patients and health care professionals. The survey will include questions around, CR referral, uptake and adherence rates. Factors that hinder and improve attendance to CR will be explored. Surveys will be distributed amongst CR patients across six centres in the United Kingdom: Sheffield, London, North of England, Scotland, Wales, and Northern Ireland. The aim is to collect survey responses from 498 patients.

Stage 2: Qualitative interviews will be carried out with both patients and professionals. Topics will include factors that improve or hinder attendance and completion of CR. In addition, factors in CR which assist with improving quality of life will be explored. This will provide a more in-depth understanding of challenges to attendance identified in study 1. Up to 10 patients from each site will be interviewed, plus up to 20 health care professionals across all sites.

Stage 3: Up to 30 participants recruited across regions will be invited to take part in a two-day workshop. The two-day co-design workshop will involve patients, clinicians, CR providers, and researchers. The aim is to develop recommendations and approaches to improving attendance and completion of CR. This will include improvements to existing CR.

Study Conduct, Participant identification, inclusion, and exclusion

研究设计

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

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Reasons people attend early cardiac rehabilitation (quantitative method).

时间窗: Start of cardiac rehabilitation

Using a pre-developed questionnaire.

Attendance to early cardiac rehabilitation

时间窗: End of cardiac rehabilitation ~ 8 weeks.

Measured by number of patients referred to cardiac rehabilitation and proportion who take up cardiac rehabilitation.

Reasons people adhere to early cardiac rehabilitation (quantitative method).

时间窗: End of cardiac rehabilitation ~ 8 weeks

Using a pre-developed questionnaire.

Reasons people drop-out of cardiac rehabilitation (quantitative method).

时间窗: 6 months after completion of cardiac rehabilitation

Using a pre-developed questionnaire.

Reasons people adhere to cardiac rehabilitation (qualitative method).

时间窗: End of cardiac rehabilitation ~ 8 weeks

Using a semi-structured qualitative interview.

Reasons people adhere to components of cardiac rehabilitation in the long term (qualitative method).

时间窗: 6 months after completion of cardiac rehabilitation

Using a semi-structured qualitative interview.

Reasons people adhere to core components of cardiac rehabilitation (quantitative method).

时间窗: 6 months after completion of cardiac rehabilitation

Using a pre-developed questionnaire.

Drop-out of early cardiac rehabilitation (quantitative method)

时间窗: End of cardiac rehabilitation ~ 8 weeks.

Drop-out will be defined as attending less than 50% of sessions.

Reasons people drop-out of early cardiac rehabilitation (qualitative method)

时间窗: End of cardiac rehabilitation ~ 8 weeks.

Using a semi-structured qualitative interview.

次要结局

  • Patient perceptions on which components of cardiac rehabilitation improve health related quality of life (quantitative method).(6 months after completion of cardiac rehabilitation)
  • Patient perceptions on which components of cardiac rehabilitation improve health related quality of life (qualitative method).(6 months after completion of cardiac rehabilitation)
  • Professional perspectives of supporting adherence to core components of cardiac rehabilitation (qualitative method).(Within 5 months from study start date.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon Nichols

Senior Research Fellow

Sheffield Hallam University

研究点 (6)

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