Coronary DiseaseINSERTNCT02185391
Interactive Education of Patients With Coronary Heart Disease
A study testing Audience Response System and Telephone interview in people with Coronary Disease, run by Paracelsus Harz Clinic Bad Suderode. at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Audience Response System and Telephone interview
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiovascular disease
Who cannot join
- Inability or refusal to give written informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Paracelsus Harz Clinic Bad Suderode
Quedlinburg, Saxony-Anhalt, 06485
About this study
Official title: 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.
- Conditions
- Coronary Disease
- Being tested
- Audience Response System, Telephone interview
- Keywords
- Coronary Disease, Audience Response System
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audience Response SystemProcedure or surgery
patients use during oral presentations an audience response system
Telephone interviewBehavioural
patients receive motivational telephone interviews after their residence in rehabilitation clinics
| Study group | Role | What they receive |
|---|---|---|
| fact-finding group | Experimental | Intervention: Audience Response System and motivational telephone interview Receives: Procedure: Audience Response System; Behavioral: Telephone interview |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 - 4 weeks
Secondary outcomes (6)
BMI and / or abdominal circumference
Change in BMI and / or abdominal circumference
Measured: 12 months
Blood Cholesterol Values
Change in Blood Cholesterol Values
Measured: 12 months
Depression Score
Change in Depression Score
Measured: 12 months
Health Related Quality of Living
Change in Health Related Quality of Living
Measured: 12 months
Stroke
Number of patients with a stroke
Measured: 12 months
Myocardial Infarction
Number of patients with Myocardial Infarction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paracelsus Harz Clinic Bad Suderode.
- Sponsor type
- University, hospital or other
- Collaborators
- The German Heart Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185391
- Sponsor's protocol ID
- ParacelsusHCBS 2013-125
- Acronym
- INSERT
- Status last verified
- Apr 2015
- First submitted
- 23 Jun 2014
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Sustainable Methods in Interactive Patient Education to Improve Adherence After Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT02185391
- Acronym / sponsor ID
- INSERT / ParacelsusHCBS 2013-125
- Conditions
- Coronary Disease
- Keywords
- Coronary Disease, Audience Response System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Paracelsus Harz Clinic Bad Suderode.University, hospital or other
- Collaborators
- The German Heart Foundation
- Study start
- May 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fact-finding group | Experimental | Procedure: Audience Response System, Behavioral: Telephone interviewIntervention: Audience Response System and motivational telephone interview |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiovascular disease
Key exclusion criteria (1 listed)
- Inability or refusal to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audience Response Systempatients use during oral presentations an audience response system | Procedure or surgery | fact-finding group |
| Telephone interviewpatients receive motivational telephone interviews after their residence in rehabilitation clinics | Behavioural | fact-finding group |
Primary outcome
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
6 secondary outcomes
BMI and / or abdominal circumference
Time frame: 12 months
Blood Cholesterol Values
Time frame: 12 months
Depression Score
Time frame: 12 months
Health Related Quality of Living
Time frame: 12 months
Stroke
Time frame: 12 months
Myocardial Infarction
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audience Response System and Telephone interview in people with Coronary Disease, run by Paracelsus Harz Clinic Bad Suderode. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Training content as a measure of success (time frame: 3 - 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2016.