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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02185391
Other study ID # ParacelsusHCBS 2013-125
Secondary ID
Status Completed
Phase N/A
First received June 23, 2014
Last updated March 29, 2016
Start date May 2014
Est. completion date November 2015

Study information

Verified date April 2015
Source Paracelsus Harz Clinic Bad Suderode.
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 260
Est. completion date November 2015
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Cardiovascular disease

Exclusion Criteria:

- Inability or refusal to give written informed consent

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Procedure:
Audience Response System
patients use during oral presentations an audience response system
Behavioral:
Telephone interview
patients receive motivational telephone interviews after their residence in rehabilitation clinics

Locations

Country Name City State
Germany Paracelsus Harz Clinic Bad Suderode Quedlinburg Saxony-Anhalt

Sponsors (2)

Lead Sponsor Collaborator
Paracelsus Harz Clinic Bad Suderode. The German Heart Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 - 4 weeks No
Secondary BMI and / or abdominal circumference Change in BMI and / or abdominal circumference 12 months No
Secondary Blood Cholesterol Values Change in Blood Cholesterol Values 12 months No
Secondary Depression Score Change in Depression Score 12 months No
Secondary Health Related Quality of Living Change in Health Related Quality of Living 12 months No
Secondary Stroke Number of patients with a stroke 12 months No
Secondary Myocardial Infarction Number of patients with Myocardial Infarction 12 months No
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