Feasibility and Acceptance of Changes in Medical Supervision of Exercise Groups in Cardiac Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 446
- 试验地点
- 8
- 主要终点
- Trust at M10
研究概览
简要总结
Exercise groups are a form of rehabilitation sport that is offered to cardiac patients (e.g. after a heart attack) in long-term rehabilitation. In Germany, the constant presence of a physician is mandatory. In order to meet the increasing demand for heart groups, the present study implements emergency care during the heart group sessions with three alternatives: paramedics, physician-on-call or specially trained instructors.
In the present study the investigators compare these alternatives (three experimental conditions) with the conventional way (control condition). Perceived safety, trust, acceptance and organisational feasibility are the main outcomes of the study. The methods used are questionnaires to the participants, instructors, organizers and, if applicable, paramedics. Additionally, partially structured interviews with attending physicians are conducted according to an interview guide.
详细描述
Exercise groups are a form of rehabilitation sport that is offered to cardiac patients (e.g. after a heart attack) in long-term rehabilitation. In Germany it is paid for by the health insurance, when certain quality criteria are fulfilled. Among others, the constant presence of a physician is mandatory. In order to meet the increasing demand for heart groups, the National Paralympic Committee Germany (NPCG) received a special permit to try other forms of medical care during a pilot project. In this so-called "supervisor conception" the physician focuses on higher-level supervision for several exercise groups. Emergency care during the heart group sessions is ensured with three alternatives: by paramedics, by a physician-on-call or by specially trained instructors.
In the present study the investigators compare these alternatives (three experimental conditions) with the conventional way (control condition). Before the start of the research project, the different versions were defined and approved by the NPCG and other responsible actors in German rehabilitation sport. The project is implemented for 12 months.
The objectives of the evaluation are:
- Safety and acceptance of the participants, instructors and supervisors with regard to medical care, consultation and cooperation, feasibility and communication between the interfaces.
- Learning effects and implementation of the training measures for emergency management and health education measures
- Implementability of the supervisor conception in the clubs and regional associations of the three model regions and transferability on the clubs and state associations of the NPCG.
The methods used are questionnaires to the participants, instructors, organizers and, if applicable, paramedics, in which the assessment of the respondents is measured for perceived safety, acceptance and feasibility. The questionnaires to the participants and instructors are carried out during a session by employees of the participating sports clubs. The organizers fill out their questionnaires at a self-chosen time point. The questionnaires were developed by the university and were sent out after the client has given his/her informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •For participants: Participation in the heart sports group with the consent of the prescribing physician
排除标准
- 未提供
结局指标
主要结局
Trust at M10
时间窗: Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Trust of the participants, instructors, organizers and paramedics towards the three alternative versions in cardiac rehabilitation. It is measured with one question offering a six-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 5 or 6 (strong rejection/ no trust).
Willingness at M10
时间窗: Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Willingness of the participants, instructors and organizers to implement the versions of the supervisor conception. It is assessed with a "yes-no-question" in the questionnaire. The feasibility criterion is met, if 50% or less of the respondents answer "no".
Potential at M10
时间窗: Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Assessment of the organizers, instructors and paramedics if the supervisor conception has the potential to be able to offer more cardiac rehabilitation groups. It is measured with one question offering a six-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 5 or 6 (strong rejection/ no potential).
Potential at M3
时间窗: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Assessment of the organizers, instructors and paramedics if the supervisor conception has the potential to be able to offer more cardiac rehabilitation groups. It is measured with one question offering a six-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 5 or 6 (strong rejection/ no potential).
Trust at M3
时间窗: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Trust of the participants, instructors, organizers and paramedics towards the three alternative versions in cardiac rehabilitation. It is measured with one question offering a six-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 5 or 6 (strong rejection/ no trust).
Willingness at M3
时间窗: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Willingness of the participants, instructors and organizers to implement the versions of the supervisor conception. It is assessed with a "yes-no-question" in the questionnaire. The feasibility criterion is met, if 50% or less of the respondents answer "no".
Costs at M3
时间窗: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Organizers are asked if the supervisor conception causes more, less or the same amount of costs compared to the conventional cardiac rehabilitation group. It is measured with one question offering a seven-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 6 or 7 (more or much more costs).
Costs at M10
时间窗: Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Organizers are asked if the supervisor conception causes more, less or the same amount of costs compared to the conventional cardiac rehabilitation group. It is measured with one question offering a seven-point Likert scale. The feasibility criterion is met, if 50% or less of the respondents tick box 6 or 7 (more or much more costs).
次要结局
未报告次要终点