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NCT Number: NCT02389153

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychosomatic Medicine and Psychotherapy, Univ. of Goettingen

Göttingen, 37075, Germany

About this study

The following assumptions will be evaluated:

  • The collaborative care concept is feasable in the context of the german health care system and leads to greater patient satisfaction
  • 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
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Patients´ satisfaction with treatment between baseline and the up to 12 months follow-up

    Time frame: 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

  2. Change in composite cardiovascular risk score

    Time frame: Baseline to six months

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

Secondary outcomes

  1. Smoking

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

    Actual smoking behavior:yes

  2. Lack of physical exercise

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

    Less than 60 minutes of light physical exercise per week

  3. LDL cholesterol

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

    A LDL value of >130mg/dl or higher

  4. Hypertension

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

    A blood pressure value of >140/90 mmHg or in a 24 hour measurement >135/85 mmHg

  5. Increased HbA1c

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

    A HbA1c value of >7,5% or higher

  6. Heightened level of stress

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

    A value in the PSS-4 >5 is an indicator for an heigtened stress level

Other outcomes

  1. Physical strain

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

    Physical strain is measured with the 6-minutes walking test

  2. Fear and depression

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

    Fear and Depression is measured with the HADS-D; Herrmann-Lingen, Buss & Snaith, 1995

  3. Self-efficacy

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

    Self-efficacy is measured with the GSW-6; Romppel et al., 2006

  4. Social support

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

    Social Support is measured with the ESSI-D, Cordes et al., 2009

  5. Health-related quality of life

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

    Quality of life is measured with the SF-12, Radoschewski & Bellach,1999

Sponsors and collaborators

Lead sponsor

University of Göttingen

Other

Collaborators

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Mar 17, 2015
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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