Feasability of Collaborative Care in the Secondary Prevention of Coronary Heart Disease
- Conditions
- Coronary Heart Disease
- Interventions
- Behavioral: collaborative care CHD
- Registration Number
- NCT02389153
- Lead Sponsor
- University of Göttingen
- 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:
1. The collaborative care concept is feasable in the context of the german health care system and leads to greater patient satisfaction
2. 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
3. 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description collaborative care CHD - waitlist collaborative care CHD Participants start with the intervention 6 months after baseline, in the meantime they receive tau. collaborative care, CHD collaborative care CHD Participants start with the collaborative care intervention at baseline directly after inclusion.
- Primary Outcome Measures
Name Time Method Change in composite cardiovascular risk score Baseline to six months Change in cardiovascular risk factor score comprised of secondary outcomes mentioned below
Patients´ satisfaction with treatment between baseline and the up to 12 months follow-up 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
- Secondary Outcome Measures
Name Time Method Smoking Baseline and up to 12 months follow-up Actual smoking behavior:yes
Lack of physical exercise Baseline and up to 12 months follow-up Less than 60 minutes of light physical exercise per week
Increased HbA1c Baseline and up to 12 months follow-up A HbA1c value of \>7,5% or higher
Hypertension Baseline and up to 12 months follow-up A blood pressure value of \>140/90 mmHg or in a 24 hour measurement \>135/85 mmHg
Heightened level of stress Baseline and up to 12 months follow-up A value in the PSS-4 \>5 is an indicator for an heigtened stress level
LDL cholesterol Baseline and up to 12 months follow-up A LDL value of \>130mg/dl or higher
Trial Locations
- Locations (1)
Department of Psychosomatic Medicine and Psychotherapy, Univ. of Goettingen
🇩🇪Göttingen, Germany