Interactive Education of Patients With Coronary Heart Disease (INSERT)
Primary Purpose
Coronary Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Audience Response System
Telephone interview
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Disease focused on measuring Coronary Disease, Audience Response System
Eligibility Criteria
Inclusion Criteria:
- Cardiovascular disease
Exclusion Criteria:
- Inability or refusal to give written informed consent
Sites / Locations
- Paracelsus Harz Clinic Bad Suderode
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
fact-finding group
control group
Arm Description
Intervention: Audience Response System and motivational telephone interview
Outcomes
Primary Outcome Measures
Training content as a measure of success
Reaching a total score (70 points) with respect to the training content as a measure of success of the current interactive patient education
Secondary Outcome Measures
BMI and / or abdominal circumference
Change in BMI and / or abdominal circumference
Blood Cholesterol Values
Change in Blood Cholesterol Values
Depression Score
Change in Depression Score
Health Related Quality of Living
Change in Health Related Quality of Living
Stroke
Number of patients with a stroke
Myocardial Infarction
Number of patients with Myocardial Infarction
Full Information
NCT ID
NCT02185391
First Posted
June 23, 2014
Last Updated
March 29, 2016
Sponsor
Paracelsus Harz Clinic Bad Suderode.
Collaborators
The German Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02185391
Brief Title
Interactive Education of Patients With Coronary Heart Disease
Acronym
INSERT
Official Title
Development of Sustainable Methods in Interactive Patient Education to Improve Adherence After Cardiac Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Paracelsus Harz Clinic Bad Suderode.
Collaborators
The German Heart Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Coronary Heart Diseases are responsible for a high number of deaths in Germany. To determine the risk factors secondary prevention is of great importance. After their residence in rehabilitation centers patients often get rid of newly required skills. In addition to that parameters like BMI, blood pressure and cholesterol level return to their initial value.
Using an Audience Response System (ARS) during oral presentations in rehabilitation centers should improve the learning effect of patients. Furthermore patients will receive motivating telephone calls in the follow-up. These methods should lead to a sustainable improvement of learning effects, health care behavior and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Coronary Disease, Audience Response System
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fact-finding group
Arm Type
Experimental
Arm Description
Intervention: Audience Response System and motivational telephone interview
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Audience Response System
Intervention Description
patients use during oral presentations an audience response system
Intervention Type
Behavioral
Intervention Name(s)
Telephone interview
Intervention Description
patients receive motivational telephone interviews after their residence in rehabilitation clinics
Primary Outcome Measure Information:
Title
Training content as a measure of success
Description
Reaching a total score (70 points) with respect to the training content as a measure of success of the current interactive patient education
Time Frame
3 - 4 weeks
Secondary Outcome Measure Information:
Title
BMI and / or abdominal circumference
Description
Change in BMI and / or abdominal circumference
Time Frame
12 months
Title
Blood Cholesterol Values
Description
Change in Blood Cholesterol Values
Time Frame
12 months
Title
Depression Score
Description
Change in Depression Score
Time Frame
12 months
Title
Health Related Quality of Living
Description
Change in Health Related Quality of Living
Time Frame
12 months
Title
Stroke
Description
Number of patients with a stroke
Time Frame
12 months
Title
Myocardial Infarction
Description
Number of patients with Myocardial Infarction
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cardiovascular disease
Exclusion Criteria:
Inability or refusal to give written informed consent
Facility Information:
Facility Name
Paracelsus Harz Clinic Bad Suderode
City
Quedlinburg
State/Province
Saxony-Anhalt
ZIP/Postal Code
06485
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Interactive Education of Patients With Coronary Heart Disease
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