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

NCT ID: NCT02389153

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2018-08-31

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

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

collaborative care, CHD

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

Group Type: EXPERIMENTAL

collaborative care CHD

Intervention Type: BEHAVIORAL

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.

collaborative care CHD - waitlist

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

Group Type: ACTIVE_COMPARATOR

collaborative care CHD

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

OTHER

Sponsor Role: collaborator

University of Göttingen

OTHER

Sponsor Role: lead

Responsible Party

Christoph Herrmann-Lingen

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christoph Herrmann-Lingen, Prof. Dr.

Role: STUDY_DIRECTOR

University of Goettingen, Department of Psychosomatic Medicine and Psychotherapy

Locations

Department of Psychosomatic Medicine and Psychotherapy, Univ. of Goettingen

Göttingen, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 31564125 (View on PubMed)

Other Identifiers

01287 Kollaborative Behandlung

Identifier Type: OTHER

Identifier Source: secondary_id

Kollaborative Behandlung-01287

Identifier Type: -

Identifier Source: org_study_id