Coronary Heart DiseaseNCT02389153
Feasability of Collaborative Care in the Secondary Prevention of Coronary Heart Disease
A study testing collaborative care CHD in people with Coronary Heart Disease, run by University of Göttingen at 1 site in Germany.
Trial summary
The main focus of the pilot study is to evaluate the feasability and effectiveness of a collaborative care intervention for patients suffering from a coronary heart disease (CHD) with insufficient controlled health related risk factors in their lifestyle. The design of the study is a wait list control design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- collaborative care CHD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2014to Aug 2018
- 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
- both sexes
- coronary heart disease (angiographically oder clinically approved)
- sufficient knowledge of the german language
- at least one not sufficient controlled risk factor : Diabetes mellitus (HbA1c>7,5%), smoking, lack of physical activity (less than 60 minutes of light physical exercise per week), heightened stress level (PSS-4 >5), arterial hypertension (blood pressure despite medication repeatedly heightened >140/90 or in a 24-hour measurement >135/85 mmHg), hypercholesteremia (LDL >130 mg/dl)
- written informed consent to participate
Who cannot join
- no existence of an medically approved coronary heart disease
- insufficient knowledge of the german language and ulterior disabilities to complete the questionnaires or to understand the education about the Intervention
- existence of a psychosis
- drug dependency (except tobacco)
- dementia
- severe episode of Depression
Show all 11Show fewer
- current suicidal tendency
- cardiac insufficiency NYHA 4
- missing informed consent
- malign tumor (unless curative treated and without relapse)
- acute coronary syndrome or cardiosurgery within the last 3 months
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychosomatic Medicine and Psychotherapy, Univ. of Goettingen
Göttingen, 37075
About this study
Official title: Feasability and Effectiveness of a Collaborative Care Intervention in the Secondary Prevention of Coronary Heart Disease - A Pilot Study
The main focus of the pilot study is to evaluate the feasability and effectiveness of a collaborative care intervention for patients suffering from a coronary heart disease (CHD) with insufficient controlled health related risk factors in their lifestyle. The design of the study is a wait list control design. 30 patients will receive treatment immediately after submission, the other 30 after 6 months. An interdisciplinary team, including a care manager for each patient, will offer an individualized treatment plan, based on shared decision making for each patient to reduce risk factors and improve quality of life.
Read the detailed description
The following assumptions will be evaluated:
- The collaborative care concept is feasable in the context of the german health care system and leads to greater patient satisfaction
- The team-based intervention leads to a decrease of cardiovascular risk factors of patients in the intervention group compared to participants in the waitlist condition
- The collaborative care intervention leads to an improvement of quality of life as well as mental well being of participants in the intervention group compared to participants of the waitlist condition
- Conditions
- Coronary Heart Disease
- Being tested
- collaborative care CHD
- Keywords
- secondary prevention coronary heart disease, myocardial infarction, cardiovascular risk factors, collaborative care, quality of life, patients´ satisfaction with treatment
- Medical subject headings
- Coronary Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collaborative care CHDBehavioural
Over a time span of 6 months participants receive individualized treatment to reduce risk factors and improve quality of life, based on their preferences following a health plan, which they developed with their health coach.
| Study group | Role | What they receive |
|---|---|---|
| collaborative care, CHD | Experimental | Participants start with the collaborative care intervention at baseline directly after inclusion. Receives: Behavioral: collaborative care CHD |
| collaborative care CHD - waitlist | Active comparator | Participants start with the intervention 6 months after baseline, in the meantime they receive tau. Receives: Behavioral: collaborative care CHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients´ satisfaction with treatment between baseline and the up to 12 months follow-up
September 2014: baseline for both groups; first 30 participants start with the Intervention, march 2015: 6-months follow-up for intervention group, participants from the wait list group start with active intervention phase, September 2015: 12-months follow-up intervention group; 6-months follow-up participants wait list group, march 2016: 12-months follow-up participants wait list group
Measured: up to 12 months follow-up
Change in composite cardiovascular risk score
Change in cardiovascular risk factor score comprised of secondary outcomes mentioned below
Measured: Baseline to six months
Secondary outcomes (6)
Smoking
Actual smoking behavior:yes
Measured: Baseline and up to 12 months follow-up
Lack of physical exercise
Less than 60 minutes of light physical exercise per week
Measured: Baseline and up to 12 months follow-up
LDL cholesterol
A LDL value of >130mg/dl or higher
Measured: Baseline and up to 12 months follow-up
Hypertension
A blood pressure value of >140/90 mmHg or in a 24 hour measurement >135/85 mmHg
Measured: Baseline and up to 12 months follow-up
Increased HbA1c
A HbA1c value of >7,5% or higher
Measured: Baseline and up to 12 months follow-up
Heightened level of stress
A value in the PSS-4 >5 is an indicator for an heigtened stress level
Measured: Baseline and up to 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJul 2014
- Primary completionNov 2017
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Responsible party
- Principal investigator, Christoph Herrmann-Lingen, University of Göttingen
- Investigators
- Christoph Herrmann-Lingen, Prof. Dr., Study director, University of Goettingen, Department of Psychosomatic Medicine and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389153
- Sponsor's protocol ID
- Kollaborative Behandlung-01287
- Other IDs
- 01287 Kollaborative Behandlung
- Status last verified
- Oct 2018
- First submitted
- 2 Dec 2014
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Bosselmann L, Fangauf SV, Herbeck Belnap B, Chavanon ML, Nagel J, Neitzel C, Schertz A, Hummers E, Wachter R, Herrmann-Lingen C. Blended collaborative care in the secondary prevention of coronary heart disease improves risk factor control: Results of a randomised feasibility study. Eur J Cardiovasc Nurs. 2020 Feb;19(2):134-141. doi: 10.1177/1474515119880062. Epub 2019 Sep 28.
PubMed 31564125
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasability and Effectiveness of a Collaborative Care Intervention in the Secondary Prevention of Coronary Heart Disease - A Pilot Study
- ClinicalTrials.gov ID
- NCT02389153
- Acronym / sponsor ID
- Kollaborative Behandlung-01287
- Conditions
- Coronary Heart Disease
- Keywords
- secondary prevention coronary heart disease, myocardial infarction, cardiovascular risk factors, collaborative care, quality of life, patients´ satisfaction with treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Study start
- Jul 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 17 Mar 2015 (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 main focus of the pilot study is to evaluate the feasability and effectiveness of a collaborative care intervention for patients suffering from a coronary heart disease (CHD) with insufficient controlled health related risk factors in their lifestyle. The design of the study is a wait list control design. 30 patients will receive treatment immediately after submission, the other 30 after 6 months. An interdisciplinary team, including a care manager for each patient, will offer an individualized treatment plan, based on shared decision making for each patient to reduce risk factors and improve quality of life.
Detailed description
The following assumptions will be evaluated:
- The collaborative care concept is feasable in the context of the german health care system and leads to greater patient satisfaction
- The team-based intervention leads to a decrease of cardiovascular risk factors of patients in the intervention group compared to participants in the waitlist condition
- The collaborative care intervention leads to an improvement of quality of life as well as mental well being of participants in the intervention group compared to participants of the waitlist condition
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| collaborative care, CHD | Experimental | Behavioral: collaborative care CHDParticipants start with the collaborative care intervention at baseline directly after inclusion. |
| collaborative care CHD - waitlist | Active comparator | Behavioral: collaborative care CHDParticipants start with the intervention 6 months after baseline, in the meantime they receive tau. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- both sexes
- coronary heart disease (angiographically oder clinically approved)
- sufficient knowledge of the german language
- at least one not sufficient controlled risk factor : Diabetes mellitus (HbA1c>7,5%), smoking, lack of physical activity (less than 60 minutes of light physical exercise per week), heightened stress level (PSS-4 >5), arterial hypertension (blood pressure despite medication repeatedly heightened >140/90 or in a 24-hour measurement >135/85 mmHg), hypercholesteremia (LDL >130 mg/dl)
- written informed consent to participate
Key exclusion criteria (11 listed)
- no existence of an medically approved coronary heart disease
- insufficient knowledge of the german language and ulterior disabilities to complete the questionnaires or to understand the education about the Intervention
- existence of a psychosis
- drug dependency (except tobacco)
- dementia
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 |
|---|---|---|
| collaborative care CHDOver a time span of 6 months participants receive individualized treatment to reduce risk factors and improve quality of life, based on their preferences following a health plan, which they developed with their health coach. | Behavioural | collaborative care CHD - waitlist, collaborative care, CHD |
Primary outcome
Patients´ satisfaction with treatment between baseline and the up to 12 months follow-up
Time frame: up to 12 months follow-up
September 2014: baseline for both groups; first 30 participants start with the Intervention, march 2015: 6-months follow-up for intervention group, participants from the wait list group start with active intervention phase, September 2015: 12-months follow-up intervention group; 6-months follow-up participants wait list group, march 2016: 12-months follow-up participants wait list group
Change in composite cardiovascular risk score
Time frame: Baseline to six months
Change in cardiovascular risk factor score comprised of secondary outcomes mentioned below
6 secondary outcomes
Smoking
Time frame: Baseline and up to 12 months follow-up
Lack of physical exercise
Time frame: Baseline and up to 12 months follow-up
LDL cholesterol
Time frame: Baseline and up to 12 months follow-up
Hypertension
Time frame: Baseline and up to 12 months follow-up
Increased HbA1c
Time frame: Baseline and up to 12 months follow-up
Heightened level of stress
Time frame: Baseline and up to 12 months follow-up
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 11 Oct 2018.
- Derived from this study: PubMed 31564125Bosselmann L, Fangauf SV, Herbeck Belnap B, Chavanon ML, Nagel J, Neitzel C, Schertz A, Hummers E, Wachter R, Herrmann-Lingen C. Blended collaborative care in the secondary prevention of coronary heart disease improves risk factor control: Results of a randomised feasibility study. Eur J Cardiovasc Nurs. 2020 Feb;19(2):134-141. doi: 10.1177/1474515119880062. Epub 2019 Sep 28.
Related trials for Coronary Heart Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Christoph Herrmann-Lingen, Prof. Dr. study director
University of Goettingen, Department of Psychosomatic Medicine and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collaborative care CHD in people with Coronary Heart Disease, run by University of Göttingen 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 5 inclusion and 11 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 11 Oct 2018. 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?
Patients´ satisfaction with treatment between baseline and the up to 12 months follow-up (time frame: up to 12 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02389153, which also lists 1 linked publication.
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 11 Oct 2018.