Clinical trial NCT01725074: 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)
Official title: Koronare Herzkrankheit Projekt Mannheim
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Multimorbidity
Keywords: Coronary Heart Disease, multimorbidity, primary care, case management, loneliness, depression, social support
Lead sponsor: Genossenschaft Gesundheitsprojekt Mannheim e.G
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: pfm medical Institute gGmbH, Germany
name: Heidelberg University
First posted: 2012-11-12
Enrollment: 320
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in health outcomes
timeFrame: Measured at baseline, 6 and 12 months follow-up
measure: Change in quality of life
timeFrame: Measured at baseline, 6 and 12 months follow-up
Secondary outcomes:
measure: Change in Loneliness
timeFrame: Measured at baseline, 6 and 12 months follow-up
measure: Change in Depression
timeFrame: Measured at baseline, 6 and 12 months follow-up
measure: Change in self-efficacy
timeFrame: Measured at baseline, 6 and 12 months follow-up
measure: Change in social support
timeFrame: Measured at baseline, 6 and 12 months follow-up
measure: Change in health locus of control
timeFrame: Measured at baseline, 6 and 12 months follow-up
measure: Change in lifestyle behavior
timeFrame: Measured at baseline, 6 and 12 months follow-up
measure: Change in social network of family and friends
timeFrame: Measured at baseline, 6 and 12 months follow-up
measure: Change in outcome expectancies
timeFrame: Measured at baseline, 6 and 12 months follow-up
measure: Change in vulnerability
timeFrame: Measured at baseline, 6 and 12 months follow-up
measure: Change in intention
timeFrame: Measured at baseline, 6 and 12 months follow-up
measure: Change in severity
timeFrame: Measured at baseline, 6 and 12 months follow-up
measure: Change in health worries
timeFrame: Measured at baseline, 6 and 12 months follow-up
measure: Change in cognitive functions
timeFrame: Measured at baseline, 6 and 12 months follow-up
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Genossenschaft Gesundheitsprojekt Mannheim e.G.
state: BW
Study officials:
References: