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) — KHK ProMA  

Coronary Heart Disease Clinical Trial

Official title: Koronare Herzkrankheit Projekt Mannheim

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Multimorbidity
• Myocardial Ischemia

• NCT number: NCT01725074
• Study type: Interventional
• Source: Genossenschaft Gesundheitsprojekt Mannheim e.G
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2011
• Completion date: March 2013