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

NCT ID: NCT04738383

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 446 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-05
• Study Completion Date: 2020-05-21

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Version 1: Paramedic

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

Group Type: EXPERIMENTAL

Version 1: Paramedic

Intervention Type: PROCEDURE

Instead of a physician, who is constantly present, a paramedic is present next to the instructor during the sessions, who can give first aid in case of an emergency and bridge the time until the ambulance arrives on site. The physician still acts as a supervisor visiting the group roughly every six weeks.

Version 2: Physician-on-call

Physician is not present, but is on call.

Group Type: EXPERIMENTAL

Version 2: Physician-on-call

Intervention Type: PROCEDURE

This version implicates that a physician is not physically present but is on call during the sessions and must be constantly accessible by phone and able to arrive within three minutes in case of an emergency. To ensure this, version two should be implemented in facilities, which are linked to cardiac or rehabilitation center.

Version 3: Trained instructor

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

Group Type: EXPERIMENTAL

Version 3: Trained instructor

Intervention Type: PROCEDURE

The sessions take place with the instructor only, who receives a comprehensive emergency training before and during the model phase and replaces the constantly present physician. Just like in the previous versions the physician still acts as a supervisor visiting the group roughly every six weeks.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Version 1: Paramedic

Instead of a physician, who is constantly present, a paramedic is present next to the instructor during the sessions, who can give first aid in case of an emergency and bridge the time until the ambulance arrives on site. The physician still acts as a supervisor visiting the group roughly every six weeks.

Intervention Type: PROCEDURE

Version 2: Physician-on-call

This version implicates that a physician is not physically present but is on call during the sessions and must be constantly accessible by phone and able to arrive within three minutes in case of an emergency. To ensure this, version two should be implemented in facilities, which are linked to cardiac or rehabilitation center.

Intervention Type: PROCEDURE

Version 3: Trained instructor

The sessions take place with the instructor only, who receives a comprehensive emergency training before and during the model phase and replaces the constantly present physician. Just like in the previous versions the physician still acts as a supervisor visiting the group roughly every six weeks.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Paralympic Committee Germany (NPCG)

UNKNOWN

Sponsor Role: collaborator

Universität Münster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benedikt Ewald

Role: STUDY_DIRECTOR

National Paralympic Committee Germany (NPCG)

Michael Brach, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universität Münster

Locations

Behinderten-Sportverband Niedersachsen e.V.

Hanover, Lower Saxony, Germany

National Paralympic Committee Germany (NPCG)

Frechen, North-Rhine Westfalia, Germany

Instiute of Sport and Exercise Sciences

Münster, North-Rhine Westfalia, Germany

Sächsischer Behinderten- und Rehabilitationssportverband e. V.

Leipzig, Saxony, Germany

Countries

Germany

Other Identifiers

2019-28-MB

Identifier Type: -

Identifier Source: org_study_id