Interactive Education of Patients With Coronary Heart Dis... | NCT02185391

Studies
Interactive Education of Patients With Coronary Heart Disease

NCT02185391

Sponsor

Paracelsus Harz Clinic Bad Suderode.

Status

Completed

Last Update Posted

Mar 30, 2016Estimated

Enrollment

260Actual

Phase

Not Applicable

Conditions

Coronary Disease

Interventions

Audience Response System
Telephone interview

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2015Actual

First Submitted Date

Jun 23, 2014

First Submission Date that Met QC Criteria

Jul 3, 2014

First Posted Date

Jul 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2016

Last Update Posted Date

Mar 30, 2016Estimated

Name	Class
The German Heart Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

260Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fact-finding group	Experimental	Intervention: Audience Response System and motivational telephone interview	Procedure: Audience Response System Behavioral: Telephone interview
control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Audience Response System	Procedure	patients use during oral presentations an audience response system	fact-finding group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
BMI and / or abdominal circumference	Change in BMI and / or abdominal circumference	12 months
Blood Cholesterol Values	Change in Blood Cholesterol Values

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cardiovascular disease

Exclusion Criteria:

Inability or refusal to give written informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Paracelsus Harz Clinic Bad Suderode		Quedlinburg	Saxony-Anhalt	06485	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007407	Interviews as Topic

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided