Coronary Heart Disease
Conditions
Keywords
secondary prevention coronary heart disease, myocardial infarction, cardiovascular risk factors, collaborative care, quality of life, patients´ satisfaction with treatment
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
Interventions
BEHAVIORALcollaborative care CHD
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.
Sponsors
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
University of Göttingen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in composite cardiovascular risk score | Baseline to six months | Change in cardiovascular risk factor score comprised of secondary outcomes mentioned below |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lack of physical exercise | Baseline and up to 12 months follow-up | Less than 60 minutes of light physical exercise per week |
| Smoking | Baseline and up to 12 months follow-up | Actual smoking behavior:yes |
| LDL cholesterol | Baseline and up to 12 months follow-up | A LDL value of \>130mg/dl 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 |
| Increased HbA1c | Baseline and up to 12 months follow-up | A HbA1c value of \>7,5% or higher |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Social support | Baseline and up to 12 months follow-up | Social Support is measured with the ESSI-D, Cordes et al., 2009 |
| Health-related quality of life | Baseline and up to 12 months follow-up | Quality of life is measured with the SF-12, Radoschewski & Bellach,1999 |
| Fear and depression | Baseline and up to 12 months follow-up | Fear and Depression is measured with the HADS-D; Herrmann-Lingen, Buss & Snaith, 1995 |
| Physical strain | Baseline and up to 12 months follow-up | Physical strain is measured with the 6-minutes walking test |
| Self-efficacy | Baseline and up to 12 months follow-up | Self-efficacy is measured with the GSW-6; Romppel et al., 2006 |
Countries
Germany
Outcome results
None listed