Interactive Education of Patients With Coronary Heart Disease (INSERT)

March 29, 2016 updated by: Paracelsus Harz Clinic Bad Suderode.

Development of Sustainable Methods in Interactive Patient Education to Improve Adherence After Cardiac Rehabilitation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxony-Anhalt
      • Quedlinburg, Saxony-Anhalt, Germany, 06485
        • Paracelsus Harz Clinic Bad Suderode

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cardiovascular disease

Exclusion Criteria:

  • Inability or refusal to give written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 - 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI and / or abdominal circumference
Time Frame: 12 months
Change in BMI and / or abdominal circumference
12 months
Blood Cholesterol Values
Time Frame: 12 months
Change in Blood Cholesterol Values
12 months
Depression Score
Time Frame: 12 months
Change in Depression Score
12 months
Health Related Quality of Living
Time Frame: 12 months
Change in Health Related Quality of Living
12 months
Stroke
Time Frame: 12 months
Number of patients with a stroke
12 months
Myocardial Infarction
Time Frame: 12 months
Number of patients with Myocardial Infarction
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paracelsus Harz Clinic Bad Suderode.

Collaborators

The German Heart Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

July 3, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

March 30, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ParacelsusHCBS 2013-125

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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