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

University of Göttingen40 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Coronary Heart Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: up to 12 months follow-up

Change in composite cardiovascular risk score

Change in cardiovascular risk factor score comprised of secondary outcomes mentioned below

Time frame: Baseline to six months

Secondary Outcomes

Smoking

Actual smoking behavior:yes

Time frame: Baseline and up to 12 months follow-up

Lack of physical exercise

Less than 60 minutes of light physical exercise per week

Time frame: Baseline and up to 12 months follow-up

LDL cholesterol

A LDL value of \>130mg/dl or higher

Time frame: 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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes