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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Behavioral: collaborative care CHD

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Göttingen, Germany, 37075
    • Department of Psychosomatic Medicine and Psychotherapy, Univ. of Goettingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: collaborative care, CHD; Participants start with the collaborative care intervention at baseline directly after inclusion.	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.
Active Comparator: collaborative care CHD - waitlist; Participants start with the intervention 6 months after baseline, in the meantime they receive tau.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in composite cardiovascular risk score	Change in cardiovascular risk factor score comprised of secondary outcomes mentioned below	Baseline to six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking	Actual smoking behavior:yes	Baseline and up to 12 months follow-up
Lack of physical exercise	Less than 60 minutes of light physical exercise per week	Baseline and up to 12 months follow-up
LDL cholesterol	A LDL value of >130mg/dl or higher	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	Baseline and up to 12 months follow-up
Increased HbA1c	A HbA1c value of >7,5% or higher	Baseline and up to 12 months follow-up
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical strain	Physical strain is measured with the 6-minutes walking test	Baseline and up to 12 months follow-up
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
Self-efficacy	Self-efficacy is measured with the GSW-6; Romppel et al., 2006	Baseline and up to 12 months follow-up
Social support	Social Support is measured with the ESSI-D, Cordes et al., 2009	Baseline and up to 12 months follow-up
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

Collaborators and Investigators

• Sponsor: University of Göttingen
• Collaborators: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
• Investigators: Study Director: Christoph Herrmann-Lingen, Prof. Dr., University of Goettingen, Department of Psychosomatic Medicine and Psychotherapy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: December 2, 2014
• First Submitted That Met QC Criteria: March 9, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: quality of life; myocardial infarction; cardiovascular risk factors; collaborative care; secondary prevention coronary heart disease; patients´ satisfaction with treatment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: Kollaborative Behandlung-01287; 01287 Kollaborative Behandlung (Other Identifier: IFS GmbH)