Heart Rehabilitation for All: A Feasibility Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Participation in rehabilitation
研究概览
简要总结
Today, 50 % of cardiac patients do not participate in cardiac rehabilitation due difficulties in navigating and accessing rehabilitation activities.
HeRTA is a partnership project involving Center for Clinical Research and Prevention (CCRP), Hvidovre Hospital, Rehabilitation Center Albertslund and Copenhagen (municipalities), the Danish Heart Association, and local sports associations. A patient advisory board participate throughout the project to ensure a continued focus on patient interests.
The overall aim of HeRTA is to develop and test the feasibility of a new, sustainable model for rehabilitation supporting patients to take part in rehabilitation and promoting life-long activity for all patients with heart disease. To ensure equal access to rehabilitation some activities are open to all patients, while others are tailored specifically to patients with vulnerability.
The project unfolds in three phases: Development (1. January 1. 2020 - 14. November 2021): Partners and patients co-create content and procedures; Feasibility (15. November 2021 - 31. July 2023): The feasibility of the model is tested, and promising components are identified; Long-term follow-up and implementation (1. August 2023 - 31. December 2025): Long term effects are investigated and promising components are tested in new settings.
During the feasibility phase the investigators will examine whether the intervention activities are feasible, acceptable, and may have positive effects for patients with heart disease. The investigators use qualitative data on implementation and acceptability of intervention among partners and patients. An randomisered controlled trial (RCT) component will assess effects on patient participation rates, health, physical activity level, and life quality. Data is collected from practitioners and patients through focus groups, observations, field notes, questionnaires, and interviews.
Results will point to:
- innovative ways to organize integrated rehabilitation pathways.
- approaches to ensuring rehabilitation targeted at patient needs.
详细描述
1. Introduction
HeRTA is a partnership project conducted in close collaboration between hospital, municipality, patient organisation and local sports associations. A patient advisory board is involved throughout the project to ensure patient involvement including that decisions continuously focus on patient needs.
The overall aim of HeRTA is to develop and test the feasibility of a new, sustainable model for rehabilitation supporting vulnerable patients to take part in rehabilitation and promoting life-long activity for all patients with heart disease.
More specifically our goal is to:
- test if combined activities across sectors can increase the proportion of cardiac patients' participating in rehabilitation
- test if the model improves the maintenance of lifestyle changes and enhances physical and mental functioning, quality of life, and self-care capacity among cardiac patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Masking is not possible as the primary outcome is participation in rehabilitation activities. However, health professionals at the hospital are allocated to either intervention or control group, to minimise cross-contamination.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with ischaemic heart disease, cardiac valve surgery, persistent atrial fibrillation, or heart failure
- •Resident in Hvidovre Hospitals uptake area
- •Cognitively functional
- •Physically able to participate in rehabilitation activities
排除标准
- •Patients, who do not meet the inclusion criteria.
研究组 & 干预措施
Intervention arm
Usual rehabilitation: training (1 hour 2 times a week for 6 weeks), dietary training (2x3 hours), cardiac education (2x3 hours), referred to municipal rehabilitation: training (1 hour 2 times a week for 6-12 weeks), patient education (3x2 hours by a cardiac nurse and 1x2 hours by a dietician).
In addition:
- Information book on rehabilitation and physical activities in local community
- 1:1 conversation with patient supporters from the Heart Association
- Employer material on post-treatment and potential work adjustments
- Support café for relatives
- Supported transition to local sports associations
- Motivating phone calls from physiotherapists supporting physical activities.
In addition for patients with vulnerabilities:
- patient education in small groups
- pro-active counselling with a cardiac nurse, a psychologist, or a social worker from the Heart Association
- paid transportation to the municipal rehabilitation Center
干预措施: Patient-targeted rehabilitation offers (Other)
Control arm
Usual rehabilitation: training (1 hour 2 times a week for 6 weeks), dietary training (2x3 hours), cardiac education (2x3 hours), referred to municipal rehabilitation: training (1 hour 2 times a week for 6-12 weeks), patient education (3x2 hours by a cardiac nurse and 1x2 hours by a dietician).
结局指标
主要结局
Participation in rehabilitation
时间窗: Up to 20 months and two weeks
The study's primary outcome is participation defined in three graduated participation levels: 1. attending ≥ one activity (proactive counseling, patient education, smoking cessation, dietary counseling, physical exercise, local sports association activity). 2. attending ≥ two activities (proactive counseling, patient education, smoking cessation, dietary counseling, physical exercise, local sports association activity). 3. attending ≥ two activities (proactive counseling, patient education, smoking cessation, dietary counseling, physical exercise, local sports association activity) and reaching at least 50% turn up
次要结局
- Sustained physical activity in leisure time(Up to 44 months + two weeks)
- Location and setting for physical activity(Up to 44 months and two weeks)
- Health-related quality of life(Up to 44 months + two weeks)
- Patient involvement(Up to 20 months and two weeks)