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)

NCT ID: NCT01725074

Last Updated: 2012-11-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-03-31

Brief Summary

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.

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.

Conditions

Coronary Heart Disease; Multimorbidity

Keywords

Coronary Heart Disease, multimorbidity, primary care, case management, loneliness, depression, social support

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Case Management "CM CHD"

Intervention Type: BEHAVIORAL

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

Social Interaction

Identical as the CM CHD group, but with exclusion of medical control measures.

Group Type: EXPERIMENTAL

Social Interaction

Intervention Type: BEHAVIORAL

Identical as the CM CHD group, but with exclusion of medical control measures and the medical aspects.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Social Interaction

Identical as the CM CHD group, but with exclusion of medical control measures and the medical aspects.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

pfm medical Institute gGmbH, Germany

UNKNOWN

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: collaborator

Genossenschaft Gesundheitsprojekt Mannheim e.G

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Genossenschaft Gesundheitsprojekt Mannheim e.G.

Mannheim, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

KHK ProMA

Identifier Type: -

Identifier Source: org_study_id