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

Coronary Heart Disease Clinical Trial

Official title:

Feasability and Effectiveness of a Collaborative Care Intervention in the Secondary Prevention of Coronary Heart Disease - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02389153
• Other study ID #: Kollaborative Behandlung-01287
• Secondary ID: 01287 Kollaborat
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: August 2018

Study information

• Verified date: October 2018
• Source: University of Göttingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Behavioral:
• collaborative 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.

Locations

Country	Name	City	State
Germany	Department of Psychosomatic Medicine and Psychotherapy, Univ. of Goettingen	Göttingen

Sponsors (2)

Lead Sponsor	Collaborator
University of Göttingen	Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical strain	Physical strain is measured with the 6-minutes walking test	Baseline and up to 12 months follow-up
Other	Fear and depression	Fear and Depression is measured with the HADS-D; Herrmann-Lingen, Buss & Snaith, 1995	Baseline and up to 12 months follow-up
Other	Self-efficacy	Self-efficacy is measured with the GSW-6; Romppel et al., 2006	Baseline and up to 12 months follow-up
Other	Social support	Social Support is measured with the ESSI-D, Cordes et al., 2009	Baseline and up to 12 months follow-up
Other	Health-related quality of life	Quality of life is measured with the SF-12, Radoschewski & Bellach,1999	Baseline and up to 12 months follow-up
Primary	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	up to 12 months follow-up
Primary	Change in composite cardiovascular risk score	Change in cardiovascular risk factor score comprised of secondary outcomes mentioned below	Baseline to six months
Secondary	Smoking	Actual smoking behavior:yes	Baseline and up to 12 months follow-up
Secondary	Lack of physical exercise	Less than 60 minutes of light physical exercise per week	Baseline and up to 12 months follow-up
Secondary	LDL cholesterol	A LDL value of >130mg/dl or higher	Baseline and up to 12 months follow-up
Secondary	Hypertension	A blood pressure value of >140/90 mmHg or in a 24 hour measurement >135/85 mmHg	Baseline and up to 12 months follow-up
Secondary	Increased HbA1c	A HbA1c value of >7,5% or higher	Baseline and up to 12 months follow-up
Secondary	Heightened level of stress	A value in the PSS-4 >5 is an indicator for an heigtened stress level	Baseline and up to 12 months follow-up