Overview

This trial is active, not recruiting.

Conditions coronary heart disease, multimorbidity
Treatments case management "cm chd", social interaction
Sponsor Genossenschaft Gesundheitsprojekt Mannheim e.G
Collaborator Merck Sharp & Dohme Corp.
Start date July 2011
End date December 2012
Trial size 320 participants
Trial identifier NCT01725074, KHK ProMA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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)
Identical as the CM CHD group, but with exclusion of medical control measures.
social interaction
Identical as the CM CHD group, but with exclusion of medical control measures and the medical aspects.
(No Intervention)
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).

Primary Outcomes

Measure
Change in health outcomes
time frame: Measured at baseline, 6 and 12 months follow-up
Change in quality of life
time frame: Measured at baseline, 6 and 12 months follow-up

Secondary Outcomes

Measure
Change in Loneliness
time frame: Measured at baseline, 6 and 12 months follow-up
Change in Depression
time frame: Measured at baseline, 6 and 12 months follow-up
Change in self-efficacy
time frame: Measured at baseline, 6 and 12 months follow-up
Change in social support
time frame: Measured at baseline, 6 and 12 months follow-up
Change in health locus of control
time frame: Measured at baseline, 6 and 12 months follow-up
Change in lifestyle behavior
time frame: Measured at baseline, 6 and 12 months follow-up
Change in social network of family and friends
time frame: Measured at baseline, 6 and 12 months follow-up
Change in outcome expectancies
time frame: Measured at baseline, 6 and 12 months follow-up
Change in vulnerability
time frame: Measured at baseline, 6 and 12 months follow-up
Change in intention
time frame: Measured at baseline, 6 and 12 months follow-up
Change in severity
time frame: Measured at baseline, 6 and 12 months follow-up
Change in health worries
time frame: Measured at baseline, 6 and 12 months follow-up
Change in cognitive functions
time frame: Measured at baseline, 6 and 12 months follow-up

Eligibility Criteria

Male or female participants at least 30 years old.

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

Additional Information

Official title Koronare Herzkrankheit Projekt Mannheim
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Genossenschaft Gesundheitsprojekt Mannheim e.G.