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

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ClinicalTrials.gov Identifier: NCT02389153
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Information provided by (Responsible Party):
Christoph Herrmann-Lingen, University of Göttingen

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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Behavioral: collaborative care CHD Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasability and Effectiveness of a Collaborative Care Intervention in the Secondary Prevention of Coronary Heart Disease - A Pilot Study
Study Start Date : July 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389153


Locations
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Germany
Department of Psychosomatic Medicine and Psychotherapy, Univ. of Goettingen
Göttingen, Germany, 37075
Sponsors and Collaborators
University of Göttingen
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators
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Study Director: Christoph Herrmann-Lingen, Prof. Dr. University of Goettingen, Department of Psychosomatic Medicine and Psychotherapy

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Responsible Party: Christoph Herrmann-Lingen, Prof. Dr., University of Göttingen
ClinicalTrials.gov Identifier: NCT02389153     History of Changes
Other Study ID Numbers: Kollaborative Behandlung-01287
01287 Kollaborative Behandlung ( Other Identifier: IFS GmbH )
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Keywords provided by Christoph Herrmann-Lingen, University of Göttingen:
secondary prevention coronary heart disease
myocardial infarction
cardiovascular risk factors
collaborative care
quality of life
patients´ satisfaction with treatment

Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases