Feasability of Collaborative Care in the Secondary Prevention of Coronary Heart Disease

Study Overview
=================
Brief 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. 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

Official Title
-----------------
Feasability and Effectiveness of a Collaborative Care Intervention in the Secondary Prevention of Coronary Heart Disease - A Pilot Study

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Behavioral: collaborative care CHD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: collaborative care, CHD<br>Participants start with the collaborative care intervention at baseline directly after inclusion. | Behavioral: collaborative care CHD<br>* 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.<br>|
| Active Comparator: collaborative care CHD - waitlist<br>Participants start with the intervention 6 months after baseline, in the meantime they receive tau. | Behavioral: collaborative care CHD<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 12 months follow-up | 
| Change in composite cardiovascular risk score | Change in cardiovascular risk factor score comprised of secondary outcomes mentioned below | Baseline to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking | Actual smoking behavior:yes | Baseline and up to 12 months follow-up | 
| Lack of physical exercise | Less than 60 minutes of light physical exercise per week | Baseline and up to 12 months follow-up | 
| LDL cholesterol | A LDL value of >130mg/dl or higher | 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 | Baseline and up to 12 months follow-up | 
| Increased HbA1c | A HbA1c value of >7,5% or higher | 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 | Baseline and up to 12 months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
secondary prevention coronary heart disease, myocardial infarction, cardiovascular risk factors, collaborative care, quality of life, patients´ satisfaction with treatment