Clinical trial NCT02389153: Feasability of Collaborative Care in the Secondary Prevention of Coronary Heart Disease
Official title: Feasability and Effectiveness of a Collaborative Care Intervention in the Secondary Prevention of Coronary Heart Disease - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Keywords: secondary prevention coronary heart disease
myocardial infarction
cardiovascular risk factors
collaborative care
quality of life
patients´ satisfaction with treatment
Lead sponsor: University of Göttingen
Sponsor class: OTHER
Collaborators: name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
First posted: 2015-03-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Patients´ satisfaction with treatment between baseline and the up to 12 months follow-up
timeFrame: up to 12 months follow-up
measure: Change in composite cardiovascular risk score
timeFrame: Baseline to six months
Secondary outcomes:
measure: Smoking
timeFrame: Baseline and up to 12 months follow-up
measure: Lack of physical exercise
timeFrame: Baseline and up to 12 months follow-up
measure: LDL cholesterol
timeFrame: Baseline and up to 12 months follow-up
measure: Hypertension
timeFrame: Baseline and up to 12 months follow-up
measure: Increased HbA1c
timeFrame: Baseline and up to 12 months follow-up
measure: Heightened level of stress
timeFrame: Baseline and up to 12 months follow-up
Other outcomes:
measure: Physical strain
timeFrame: Baseline and up to 12 months follow-up
measure: Fear and depression
timeFrame: Baseline and up to 12 months follow-up
measure: Self-efficacy
timeFrame: Baseline and up to 12 months follow-up
measure: Social support
timeFrame: Baseline and up to 12 months follow-up
measure: Health-related quality of life
timeFrame: Baseline and up to 12 months follow-up
Locations:
city: Göttingen
country: Germany
facility: Department of Psychosomatic Medicine and Psychotherapy, Univ. of Goettingen
Study officials:
affiliation: University of Goettingen, Department of Psychosomatic Medicine and Psychotherapy
name: Christoph Herrmann-Lingen, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: 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.