Feasibility and Acceptance of Changes in Medical Supervision of Exercise Groups in Cardiac Rehabilitation

Universität Münster

Status: Completed

Conditions: Cardiac Rehabilitation; Feasibility Studies; Organization and Administration; Rehabilitation Exercise

Treatments: Procedure: Version 2: Physician-on-call; Procedure: Version 3: Trained instructor; Procedure: Version 1: Paramedic

Study type: Interventional

Funder types: Other

Identifiers

NCT04738383

2019-28-MB

Details and patient eligibility

About

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.

Full description

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.

Additionally, partially structured interviews with attending physicians are conducted according to an interview guide. The questions address the physicians' assessment of safety, acceptance and feasibility of the supervisor conception.The guidelines are developed by us and are used by us after approval by the client. We conduct the interviews ourselves by telephone and evaluate them.

Enrollment: 446 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• For participants: Participation in the heart sports group with the consent of the prescribing physician

Exclusion criteria

• None

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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446 participants in 4 patient groups

Version 1: Paramedic

Experimental group

Description:

Physician is replaced by a paramedic, but the physician still acts as a supervisor.

Treatment:

Procedure: Version 1: Paramedic

Version 2: Physician-on-call

Experimental group

Description:

Physician is not present, but is on call.

Treatment:

Procedure: Version 2: Physician-on-call

Version 3: Trained instructor

Experimental group

Description:

Physician acts as a supervisor, but is not constantly present. The instructor received a special training preparing for emergency cases.

Treatment:

Procedure: Version 3: Trained instructor

Control group

No Intervention group

Description:

The sessions take place in the usual way, meaning that a physician is present in every session.