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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)

NCT01725074 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2012-11-12

No results posted yet for this study

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.

Conditions

Interventions

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

BEHAVIORAL

Social Interaction

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

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • pfm medical Institute gGmbH, Germany

    collaborator UNKNOWN

  • Heidelberg University

    collaborator OTHER

  • Genossenschaft Gesundheitsprojekt Mannheim e.G

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-12-31
Completion
2013-03-31

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01725074 on ClinicalTrials.gov