Cardiovascular EventsSINKONCT01589536
Social Medical Progression of Coronary Heart Disease With Associated Psychosocial Comorbidity -Interval Rehabilitation.
A study testing interval-rehabilitation in people with Cardiovascular Events, run by Clinic Roderbirken at 1 site in Germany.
Trial summary
The purpose of the study is to verfiy the hypothesis if a short intensive psychocardiological interval-intervention, combined with a structured follow up, decreases the rate of disability retirements caused by psychosocial co-morbidity of patients with coronary heart disease. Read more about this study
- Who is it for?
- Ages 18 to 58 years
- Conditions the study is for
- Cardiovascular Events
- What is being tested?
- interval-rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Dec 2016
- 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 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Coronary heart disease
- Disease-related psychosocial morbidity
- not a disability retirements
- Insured with the German Rheinland pension (deutsche Rentenversicherung Rheinland)
- Sufficient language skills
- Age 18-58
Who cannot join
- Acute cardiac decompensation
- consuming the underlying disease
- psychotic disorder
- Acute suicidality
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Clinic Roderbirken
Leichlingen, North Rhine-Westphalia, 42799
Sarah Neuhaeuser, :+ 49 (2175) 82 - 3352, sarah.neuhaeuser@klinik-roderbirken.de
Wolfgang Mayer-Berger, Dr. med., +49 (2175) 82-4010, wolfgang.mayer-berger@klinik-roderbirken.de
About this study
Official title: Improvement of the Social Medical Progression of Coronary Heart Disease With Associated Psychosocial Comorbidity by the Use of Interval Rehabilitation.
The purpose of the study is to verfiy the hypothesis if a short intensive psychocardiological interval-intervention, combined with a structured follow up, decreases the rate of disability retirements caused by psychosocial co-morbidity of patients with coronary heart disease.
Read the detailed description
The purpose of the study is to verfiy the hypothesis if a short intensive psychocardiological interval intervention, combined with a structured follow up, decreases the rate of disability retirements caused by psychosocial co-morbidity of patients with coronary heart disease.
- Conditions
- Cardiovascular Events
- Being tested
- interval-rehabilitation
- Keywords
- psychocardiological, interval intervention, disability pension, risk profile, mental comorbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interval-rehabilitationOther
Also called psychocardiological, interval rehabilitation, Roderbirken, comorbidity
The Patients in the intervention group receive a Stationary psychocardiological interval-rehabilitation.The Interval rehabilitation is divided into individual psychological therapy with focus of Behavior therapy and relaxation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Interventiongroup | Experimental | A Stationary psychocardiological interval-rehabilitation. Receives: Other: interval-rehabilitation |
| controlgroup | No intervention | The Patients in the control group receive a personal recommendation concerning psychotherapy outpatient counseling and therapy services at home and take therapeutic help. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the social medical progression of coronary heart disease with associated psychosocial comorbidity by the use of interval rehabilitaion
Reducing the rate of disability pension of 18%of 9% by interval-rehabilitation with aftercare.
Measured: 24 months after including study
Secondary outcomes (1)
Improvement of the social medical progression of coronary heart disease with associated psychosocial comorbidity by the use of interval rehabilitaion
Reduction of cardiovascular events, including deaths Improving the risk profile Improvement of health-related quality of life Improvement of mental comorbidity
Measured: 24 months after including study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startOct 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular EventsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinic Roderbirken
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wolfgang Mayer-Berger, MD, Principal investigator, Clinic Roderbirken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589536
- Sponsor's protocol ID
- 10001
- Acronym
- SINKO
- Status last verified
- Apr 2012
- First submitted
- 2 Mar 2012
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of the Social Medical Progression of Coronary Heart Disease With Associated Psychosocial Comorbidity by the Use of Interval Rehabilitation.
- ClinicalTrials.gov ID
- NCT01589536
- Acronym / sponsor ID
- SINKO / 10001
- Conditions
- Cardiovascular Events
- Keywords
- psychocardiological, interval intervention, disability pension, risk profile, mental comorbidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Clinic RoderbirkenUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 May 2012 (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.
The purpose of the study is to verfiy the hypothesis if a short intensive psychocardiological interval-intervention, combined with a structured follow up, decreases the rate of disability retirements caused by psychosocial co-morbidity of patients with coronary heart disease.
Detailed description
The purpose of the study is to verfiy the hypothesis if a short intensive psychocardiological interval intervention, combined with a structured follow up, decreases the rate of disability retirements caused by psychosocial co-morbidity of patients with coronary heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventiongroup | Experimental | Other: interval-rehabilitationA Stationary psychocardiological interval-rehabilitation. |
| controlgroup | No intervention | –The Patients in the control group receive a personal recommendation concerning psychotherapy outpatient counseling and therapy services at home and take therapeutic help. |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Coronary heart disease
- Disease-related psychosocial morbidity
- not a disability retirements
- Insured with the German Rheinland pension (deutsche Rentenversicherung Rheinland)
- Sufficient language skills
Key exclusion criteria (5 listed)
- Acute cardiac decompensation
- consuming the underlying disease
- psychotic disorder
- Acute suicidality
- pregnancy
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 |
|---|---|---|
| interval-rehabilitationAlso: psychocardiological, interval rehabilitation, Roderbirken, comorbidityThe Patients in the intervention group receive a Stationary psychocardiological interval-rehabilitation.The Interval rehabilitation is divided into individual psychological therapy with focus of Behavior therapy and relaxation therapy. | Other | Interventiongroup |
Primary outcome
Improvement of the social medical progression of coronary heart disease with associated psychosocial comorbidity by the use of interval rehabilitaion
Time frame: 24 months after including study
Reducing the rate of disability pension of 18%of 9% by interval-rehabilitation with aftercare.
1 secondary outcome
Improvement of the social medical progression of coronary heart disease with associated psychosocial comorbidity by the use of interval rehabilitaion
Time frame: 24 months after including study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
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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.
Wolfgang Mayer-Berger, MD principal investigator
Clinic Roderbirken
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interval-rehabilitation in people with Cardiovascular Events, run by Clinic Roderbirken 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 May 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of the social medical progression of coronary heart disease with associated psychosocial comorbidity by the use of interval rehabilitaion (time frame: 24 months after including study). 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 2 May 2012.