Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04738383
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2021-01-25
Brief Title:
Feasibility and Acceptance of Changes in Medical Supervision of Exercise Groups in Cardiac Rehabilitation
Sponsor:
Universität Münster
Organization:
Universität Münster
Study Overview
Official Title:
Feasibility and Acceptance of Changes in Medical Supervision of Exercise Groups in Cardiac Rehabilitation
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Exercise groups are a form of rehabilitation sport that is offered to cardiac patients eg 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
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 eg 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 hisher 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 conceptionThe 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
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 hisher 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 conceptionThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None