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

NCT02389153 | Completed

• 2 other identifiers: Kollaborative Behandlung-0128701287 Kollaborative Behandlung
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Keywords

secondary prevention coronary heart disease; myocardial infarction; cardiovascular risk factors; collaborative care; quality of life; patients´ satisfaction with treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Smoking

  Baseline and up to 12 months follow-up

• Lack of physical exercise

  Baseline and up to 12 months follow-up

• LDL cholesterol

  Baseline and up to 12 months follow-up

• Hypertension

  Baseline and up to 12 months follow-up

• Increased HbA1c

  Baseline and up to 12 months follow-up

Other Outcomes (5)

• Physical strain

  Baseline and up to 12 months follow-up

• Fear and depression

  Baseline and up to 12 months follow-up

• Self-efficacy

  Baseline and up to 12 months follow-up

Study Arms (2)

collaborative care, CHD

EXPERIMENTAL

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

Behavioral: collaborative care CHD

collaborative care CHD - waitlist

ACTIVE COMPARATOR

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

Behavioral: collaborative care CHD

Interventions

collaborative care CHD 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; collaborative care, CHD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Göttingen: lead
• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK): collaborator

Study Sites (1)

Department of Psychosomatic Medicine and Psychotherapy, Univ. of Goettingen

Göttingen, 37075, Germany

Location

Related Publications (1)

• 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.

  PMID: 31564125 DERIVED

MeSH Terms

Conditions

Coronary Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Christoph Herrmann-Lingen, Prof. Dr.

  University of Goettingen, Department of Psychosomatic Medicine and Psychotherapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: March 17, 2015
• Study Start: July 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: August 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

DE (1)