Clinical trial NCT04738383: Feasibility and Acceptance of Changes in Medical Supervision of Exercise Groups in Cardiac Rehabilitation
Official title: Feasibility and Acceptance of Changes in Medical Supervision of Exercise Groups in Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Rehabilitation
Rehabilitation Exercise
Organization and Administration
Feasibility Studies
Keywords: perceived safety
cardiac rehabilitation
exercise
medical supervision
Lead sponsor: Universität Münster
Sponsor class: OTHER
Collaborators: name: National Paralympic Committee Germany (NPCG)
First posted: 2021-02-04
Enrollment: 446
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control group and 3 different forms of medical supervision
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Trust at M3
timeFrame: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
measure: Trust at M10
timeFrame: Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
measure: Willingness at M3
timeFrame: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
measure: Willingness at M10
timeFrame: Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
measure: Potential at M3
timeFrame: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
measure: Potential at M10
timeFrame: Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
measure: Costs at M3
timeFrame: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
measure: Costs at M10
timeFrame: Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Secondary outcomes:
Other outcomes:
measure: Other questions on the implementation of the concept (M3)
timeFrame: Month 3 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
measure: Other questions on the implementation of the concept (M10)
timeFrame: Month 10 of the intervention. The clubs received the questionnaires by mail and had one month to fill them out and send them back.
Locations:
city: Hannover
country: Germany
facility: Behinderten-Sportverband Niedersachsen e.V.
state: Lower Saxony
city: Frechen
country: Germany
facility: National Paralympic Committee Germany (NPCG)
state: North-Rhine Westfalia
city: Münster
country: Germany
facility: Instiute of Sport and Exercise Sciences
state: North-Rhine Westfalia
city: Leipzig
country: Germany
facility: Sächsischer Behinderten- und Rehabilitationssportverband e. V.
state: Saxony
Study officials:
affiliation: National Paralympic Committee Germany (NPCG)
name: Benedikt Ewald
role: STUDY_DIRECTOR
affiliation: Universität Münster
name: Michael Brach, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: