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

Cardiac Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04738383
• Other study ID #: 2019-28-MB
• Status: Completed
• Phase: N/A
• Start date: November 5, 2018
• Est. completion date: May 21, 2020

Study information

• Verified date: October 2020
• Source: Westfälische Wilhelms-Universität Münster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: May 21, 2020
• Est. primary completion date: December 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Germany	National Paralympic Committee Germany (NPCG)	Frechen	North-Rhine Westfalia
Germany	Behinderten-Sportverband Niedersachsen e.V.	Hannover	Lower Saxony
Germany	Sächsischer Behinderten- und Rehabilitationssportverband e. V.	Leipzig	Saxony
Germany	Instiute of Sport and Exercise Sciences	Münster	North-Rhine Westfalia

Sponsors (2)

Lead Sponsor	Collaborator
Westfälische Wilhelms-Universität Münster	National Paralympic Committee Germany (NPCG)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other questions on the implementation of the concept (M3)	The questionnaire containing the 4 primary outcome questions includes also other questions on the implementation of the concept, e.g. the supervision, the communication between actors and the activity of the exercise instructor. No score is calculated.	Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Other	Other questions on the implementation of the concept (M10)	The questionnaire containing the 4 primary outcome questions includes also other questions on the implementation of the concept, e.g. the supervision, the communication between actors and the activity of the exercise instructor. No score is calculated.	Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Primary	Trust at M3	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).	Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Primary	Trust at M10	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).	Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Primary	Willingness at M3	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".	Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Primary	Willingness at M10	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".	Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Primary	Potential at M3	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).	Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Primary	Potential at M10	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).	Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Primary	Costs at M3	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).	Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Primary	Costs at M10	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).	Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.