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

University of Göttingen

Status: Completed

Conditions: Coronary Heart Disease

Treatments: Behavioral: collaborative care CHD

Study type: Interventional

Funder types: Other

Identifiers

NCT02389153

01287 Kollaborative Behandlung (Other Identifier)

Kollaborative Behandlung-01287

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

collaborative care, CHD

Experimental group

Description:

Participants start with the collaborative care intervention at baseline directly after inclusion.

Treatment:

Behavioral: collaborative care CHD

collaborative care CHD - waitlist

Active Comparator group

Description:

Participants start with the intervention 6 months after baseline, in the meantime they receive tau.

Treatment:

Behavioral: collaborative care CHD