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

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
collaborative care CHD
Sponsored by
University of Göttingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Heart Disease focused on measuring secondary prevention coronary heart disease, myocardial infarction, cardiovascular risk factors, collaborative care, quality of life, patients´ satisfaction with treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychosomatic Medicine and Psychotherapy, Univ. of Goettingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

collaborative care, CHD

collaborative care CHD - waitlist

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Smoking
Actual smoking behavior:yes
Lack of physical exercise
Less than 60 minutes of light physical exercise per week
LDL cholesterol
A LDL value of >130mg/dl or higher
Hypertension
A blood pressure value of >140/90 mmHg or in a 24 hour measurement >135/85 mmHg
Increased HbA1c
A HbA1c value of >7,5% or higher
Heightened level of stress
A value in the PSS-4 >5 is an indicator for an heigtened stress level

Full Information

First Posted
December 2, 2014
Last Updated
October 9, 2018
Sponsor
University of Göttingen
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
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1. Study Identification

Unique Protocol Identification Number
NCT02389153
Brief Title
Feasability of Collaborative Care in the Secondary Prevention of Coronary Heart Disease
Official Title
Feasability and Effectiveness of a Collaborative Care Intervention in the Secondary Prevention of Coronary Heart Disease - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Göttingen
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
secondary prevention coronary heart disease, myocardial infarction, cardiovascular risk factors, collaborative care, quality of life, patients´ satisfaction with treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
collaborative care, CHD
Arm Type
Experimental
Arm Description
Participants start with the collaborative care intervention at baseline directly after inclusion.
Arm Title
collaborative care CHD - waitlist
Arm Type
Active Comparator
Arm Description
Participants start with the intervention 6 months after baseline, in the meantime they receive tau.
Intervention Type
Behavioral
Intervention Name(s)
collaborative care CHD
Intervention Description
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 Measure Information:
Title
Patients´ satisfaction with treatment between baseline and the up to 12 months follow-up
Description
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
Time Frame
up to 12 months follow-up
Title
Change in composite cardiovascular risk score
Description
Change in cardiovascular risk factor score comprised of secondary outcomes mentioned below
Time Frame
Baseline to six months
Secondary Outcome Measure Information:
Title
Smoking
Description
Actual smoking behavior:yes
Time Frame
Baseline and up to 12 months follow-up
Title
Lack of physical exercise
Description
Less than 60 minutes of light physical exercise per week
Time Frame
Baseline and up to 12 months follow-up
Title
LDL cholesterol
Description
A LDL value of >130mg/dl or higher
Time Frame
Baseline and up to 12 months follow-up
Title
Hypertension
Description
A blood pressure value of >140/90 mmHg or in a 24 hour measurement >135/85 mmHg
Time Frame
Baseline and up to 12 months follow-up
Title
Increased HbA1c
Description
A HbA1c value of >7,5% or higher
Time Frame
Baseline and up to 12 months follow-up
Title
Heightened level of stress
Description
A value in the PSS-4 >5 is an indicator for an heigtened stress level
Time Frame
Baseline and up to 12 months follow-up
Other Pre-specified Outcome Measures:
Title
Physical strain
Description
Physical strain is measured with the 6-minutes walking test
Time Frame
Baseline and up to 12 months follow-up
Title
Fear and depression
Description
Fear and Depression is measured with the HADS-D; Herrmann-Lingen, Buss & Snaith, 1995
Time Frame
Baseline and up to 12 months follow-up
Title
Self-efficacy
Description
Self-efficacy is measured with the GSW-6; Romppel et al., 2006
Time Frame
Baseline and up to 12 months follow-up
Title
Social support
Description
Social Support is measured with the ESSI-D, Cordes et al., 2009
Time Frame
Baseline and up to 12 months follow-up
Title
Health-related quality of life
Description
Quality of life is measured with the SF-12, Radoschewski & Bellach,1999
Time Frame
Baseline and up to 12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Herrmann-Lingen, Prof. Dr.
Organizational Affiliation
University of Goettingen, Department of Psychosomatic Medicine and Psychotherapy
Official's Role
Study Director
Facility Information:
Facility Name
Department of Psychosomatic Medicine and Psychotherapy, Univ. of Goettingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
31564125
Citation
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.
Results Reference
derived

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

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