Randomized Control Trial to Evaluate Effectiveness of a Case Managment Program Regarding Psychosocial Well-being and Disease Symptoms Health for Patients With Multimorbid Coronary Heart Disease (CHD) Patients (KHK ProMA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
pfm medical Institute gGmbH, Germany
Mannheim Institute of Public Health, Social and Preventive Medicine, Medical Faculty Mannheim, Heidelberg University
Information provided by (Responsible Party):
Genossenschaft Gesundheitsprojekt Mannheim e.G
ClinicalTrials.gov Identifier:
NCT01725074
First received: November 8, 2012
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

This randomized controlled trial (RCT) will examine a case management program for patients suffering from coronary heart disease with multimorbidity in Mannheim, Germany. The trail consists of 3 treatment arms: 1) intensified case management; 2) social interaction alone 3) standard care. The main objectives are to evaluate how case management and social interaction alone compared to standard medical care affect the primary and secondary outcomes: physical health, quality of life, loneliness, depression, self-efficacy, outcome expectancies, social support, health locus of control, lifestyle behavior, social network, vulnerability, intention, severity, health worries and cognitive functions.


Condition Intervention
Coronary Heart Disease
Multimorbidity
Behavioral: Case Management "CM CHD"
Behavioral: Social Interaction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Koronare Herzkrankheit Projekt Mannheim

Resource links provided by NLM:


Further study details as provided by Genossenschaft Gesundheitsprojekt Mannheim e.G:

Primary Outcome Measures:
  • Change in health outcomes [ Time Frame: Measured at baseline, 6 and 12 months follow-up ] [ Designated as safety issue: No ]

    This includes biomarkers (blood pressure, BMI, weight, blood lipids), physical balance performance (semi tandem stand), care utilization and medication usage, clinical assessments and need for (medical) treatment (like dyspnea, fatigue, care, vomitus, thirst, lack of appetite, nausea, disorientation).

    Within the intervention group CM CHD weight and blood pressure is self-reported by patients biweekly within the first six months and monthly within the second six months.


  • Change in quality of life [ Time Frame: Measured at baseline, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    We will measure this variable using the "EQ-5D" and two additional items.


Secondary Outcome Measures:
  • Change in Loneliness [ Time Frame: Measured at baseline, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    We will measure this variable using the "Hamburger Einsamkeits-Skala (HES)" a German version of the UCLA-Loneliness Scale.

  • Change in Depression [ Time Frame: Measured at baseline, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    We will measure this variable using the "Patient Health Questionnaire - 9 item (PHQ-9) instrument".

  • Change in self-efficacy [ Time Frame: Measured at baseline, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    We will measure this variable using the "SWE" questionnaire as well as items of self-efficacy regarding sports, quit smoking and healthier eating behavior.

  • Change in social support [ Time Frame: Measured at baseline, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    We will measure this variable using the "Skala sozialer Unterstützung bei Krankheit (SSUK)". This instrument consists of two subscales, supportive behavior as well as stressful interactions.

  • Change in health locus of control [ Time Frame: Measured at baseline, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    We will measure this variable using the "MHLC-C". This instrument consists of four subscales, internal, chance, doctors and other people.

  • Change in lifestyle behavior [ Time Frame: Measured at baseline, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    This includes smoking, alcohol consumption, eating habits and physical activity.

  • Change in social network of family and friends [ Time Frame: Measured at baseline, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    This includes the number of closer family members and friends and the amount of contact with them.

  • Change in outcome expectancies [ Time Frame: Measured at baseline, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    This includes items regarding sports, quit smoking and healthier eating behavior.

  • Change in vulnerability [ Time Frame: Measured at baseline, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    This includes the total vulnerability regarding specific diseases for one's own person as well as for a peer/other person. Thus the relative vulnerability can be determined.

  • Change in intention [ Time Frame: Measured at baseline, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    This includes items of intentions for a healthier lifestyle like more physical activity, quit smoking and healthier eating behaviors.

  • Change in severity [ Time Frame: Measured at baseline, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    This includes the estimated severity of different cardiovascular diseases in general as well as their severity for the own individual.

  • Change in health worries [ Time Frame: Measured at baseline, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    This includes worries about the own health in general as well as regarding specific health problems like blood pressure, high cholesterol or the risk of a myocardial infarction.

  • Change in cognitive functions [ Time Frame: Measured at baseline, 6 and 12 months follow-up ] [ Designated as safety issue: No ]
    This will be measured using the Mini-mental Status Exam and the Clock Drawing Test.


Enrollment: 320
Study Start Date: July 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Case Management "CM CHD"
The intervention consists of a biweekly telephone or personal contact by trained case managers over the first 6-months and monthly contact over the second 6-months to assess well-being, everyday life (positive, neutral and negative daily events), and to inquire after health and personal problems on which basis the case manager offers practical or emotional support or a referral to the general practitioner if deemed necessary. During the contacts also medical control measures like blood pressure or weight are taken, and other study outcome measures like need for medical treatment.
Behavioral: Case Management "CM CHD"

Patients, who are randomized to the intervention group, will receive case management from a trained and experienced physician assistant. The case manager will carry out following tasks:

  • Biweekly/monthly telephone consultations or home visits
  • Identification of health or personal problems of the patient
  • Monitoring of medical parameters
  • Coordination of contact with health care providers if necessary
  • Support to the patient related to health status and environmental changes
  • Promote disease-self management through coaching
  • Counseling, that is focused on emotional support and active listening
Experimental: Social Interaction
Identical as the CM CHD group, but with exclusion of medical control measures.
Behavioral: Social Interaction
Identical as the CM CHD group, but with exclusion of medical control measures and the medical aspects.
No Intervention: Control Group
Patients assigned to the control group received usual care (no additional contact/support) and therefore stays under the standard supervision of the general practitioner i.e. as participant in the normal disease management program for CHD (quarterly check-ups).

Detailed Description:

This randomized controlled trial (RCT) will examine a case management program for 320 male and female patients suffering from coronary heart disease with multimorbidity in Mannheim, Germany. The main objectives are to evaluate how case management and social interaction alone compared to standard medical care affect the primary and secondary outcomes: physical health, quality of life, loneliness, depression, self-efficacy, outcome expectancies, social support, health locus of control, lifestyle behavior, social network, vulnerability, intention, severity, health worries and cognitive functions.

Additionally, the secondary outcomes are studied as factors that mediate the effects of case management and social interaction alone compared to standard medical care on the primary outcomes.

The trail consists of 3 treatment arms: 1) intensified case management; 2) social interaction alone 3) usual care. The intervention consists of a biweekly contact by trained case managers over the first 6-months and a monthly contact over the subsequent 6-months. Each contact involves an assessment of well-being, daily life, problems and offering emotional support and solutions or refer to the general practitioner if necessary (both intervention groups).

For patients assigned to the "CM CHD" the contacts include medical control (like blood pressure or weight) and well-being as well as an additional core set of relevant outcome measures (e.g. need for treatment of fatigue).

Patients assigned to the control group received usual care (no CM or contact). An additional fourth group is monitored. This group is consisting of patients who refused to take part in the study but gave consent to collect their practice data (not randomized).

Each patient will be followed for 12 months. Extensive assessments and self-administered questionnaires take place at baseline, 6-month and 12-month for all patients in the three randomized groups.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed CHD

    • participation in the Disease Management Program (DMP) of CHD or
    • a risk score (Framingham or Procam) higher than 20%
  • two additional chronic diseases (multimorbid)

Exclusion Criteria:

  • Patients living in institutionalized care
  • Patients having dementia
  • Patients associated with a life expectancy of less than one year
  • Patients who are not able to communicate in German language
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725074

Locations
Germany
Genossenschaft Gesundheitsprojekt Mannheim e.G.
Mannheim, BW, Germany, 68259
Sponsors and Collaborators
Genossenschaft Gesundheitsprojekt Mannheim e.G
Merck Sharp & Dohme Corp.
pfm medical Institute gGmbH, Germany
Mannheim Institute of Public Health, Social and Preventive Medicine, Medical Faculty Mannheim, Heidelberg University
  More Information

No publications provided

Responsible Party: Genossenschaft Gesundheitsprojekt Mannheim e.G
ClinicalTrials.gov Identifier: NCT01725074     History of Changes
Other Study ID Numbers: KHK ProMA
Study First Received: November 8, 2012
Last Updated: November 9, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Genossenschaft Gesundheitsprojekt Mannheim e.G:
Coronary Heart Disease, multimorbidity, primary care, case management, loneliness, depression, social support

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

ClinicalTrials.gov processed this record on August 19, 2014