NCT02185391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 30, 2016

Status Verified

April 1, 2015

Enrollment Period

6 months

First QC Date

June 23, 2014

Last Update Submit

March 29, 2016

Conditions

Keywords

Coronary DiseaseAudience Response System

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • BMI and / or abdominal circumference

    12 months

  • Blood Cholesterol Values

    12 months

  • Depression Score

    12 months

  • Health Related Quality of Living

    12 months

  • Stroke

    12 months

  • +1 more secondary outcomes

Study Arms (2)

fact-finding group

EXPERIMENTAL

Intervention: Audience Response System and motivational telephone interview

Procedure: Audience Response SystemBehavioral: Telephone interview

control group

NO INTERVENTION

Interventions

patients use during oral presentations an audience response system

fact-finding group

patients receive motivational telephone interviews after their residence in rehabilitation clinics

fact-finding group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiovascular disease

You may not qualify if:

  • Inability or refusal to give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paracelsus Harz Clinic Bad Suderode

Quedlinburg, Saxony-Anhalt, 06485, Germany

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2014

First Posted

July 9, 2014

Study Start

May 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2015

Last Updated

March 30, 2016

Record last verified: 2015-04

Locations