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Interactive Education of Patients With Coronary Heart Disease (INSERT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02185391
Recruitment Status : Completed
First Posted : July 9, 2014
Last Update Posted : March 30, 2016
The German Heart Foundation
Information provided by (Responsible Party):
Paracelsus Harz Clinic Bad Suderode.

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.

Condition or disease Intervention/treatment Phase
Coronary Disease Procedure: Audience Response System Behavioral: Telephone interview Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development of Sustainable Methods in Interactive Patient Education to Improve Adherence After Cardiac Rehabilitation
Study Start Date : May 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: fact-finding group
Intervention: Audience Response System and motivational telephone interview
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

No Intervention: control group

Primary Outcome Measures :
  1. Training content as a measure of success [ Time Frame: 3 - 4 weeks ]
    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 :
  1. BMI and / or abdominal circumference [ Time Frame: 12 months ]
    Change in BMI and / or abdominal circumference

  2. Blood Cholesterol Values [ Time Frame: 12 months ]
    Change in Blood Cholesterol Values

  3. Depression Score [ Time Frame: 12 months ]
    Change in Depression Score

  4. Health Related Quality of Living [ Time Frame: 12 months ]
    Change in Health Related Quality of Living

  5. Stroke [ Time Frame: 12 months ]
    Number of patients with a stroke

  6. Myocardial Infarction [ Time Frame: 12 months ]
    Number of patients with Myocardial Infarction

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Cardiovascular disease

Exclusion Criteria:

  • Inability or refusal to give written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02185391

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Paracelsus Harz Clinic Bad Suderode
Quedlinburg, Saxony-Anhalt, Germany, 06485
Sponsors and Collaborators
Paracelsus Harz Clinic Bad Suderode.
The German Heart Foundation

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Responsible Party: Paracelsus Harz Clinic Bad Suderode. Identifier: NCT02185391     History of Changes
Other Study ID Numbers: ParacelsusHCBS 2013-125
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: April 2015
Keywords provided by Paracelsus Harz Clinic Bad Suderode.:
Coronary Disease
Audience Response System
Additional relevant MeSH terms:
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Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases