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)

Coronary Heart Disease Clinical Trial

— KHK ProMA  

Official title:

Koronare Herzkrankheit Projekt Mannheim

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01725074
• Other study ID #: KHK ProMA
• Status: Active, not recruiting
• Phase: N/A
• First received: November 8, 2012
• Last updated: November 9, 2012
• Start date: July 2011
• Est. completion date: March 2013

Study information

• Verified date: November 2012
• Source: Genossenschaft Gesundheitsprojekt Mannheim e.G
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

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

Intervention

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

Locations

Country	Name	City	State
Germany	Genossenschaft Gesundheitsprojekt Mannheim e.G.	Mannheim	BW

Sponsors (4)

Lead Sponsor	Collaborator
Genossenschaft Gesundheitsprojekt Mannheim e.G	Heidelberg University, Merck Sharp & Dohme Corp., pfm medical Institute gGmbH, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in health outcomes	This includes biomarkers (blood pressure, BMI, weight, blood lipids), physical balance performance (semi tandem stand), care utilization and medication usage, clinical assessments and need for (medical) treatment (like dyspnea, fatigue, care, vomitus, thirst, lack of appetite, nausea, disorientation).; Within the intervention group CM CHD weight and blood pressure is self-reported by patients biweekly within the first six months and monthly within the second six months.	Measured at baseline, 6 and 12 months follow-up	No
Primary	Change in quality of life	We will measure this variable using the "EQ-5D" and two additional items.	Measured at baseline, 6 and 12 months follow-up	No
Secondary	Change in Loneliness	We will measure this variable using the "Hamburger Einsamkeits-Skala (HES)" a German version of the UCLA-Loneliness Scale.	Measured at baseline, 6 and 12 months follow-up	No
Secondary	Change in Depression	We will measure this variable using the "Patient Health Questionnaire - 9 item (PHQ-9) instrument".	Measured at baseline, 6 and 12 months follow-up	No
Secondary	Change in self-efficacy	We will measure this variable using the "SWE" questionnaire as well as items of self-efficacy regarding sports, quit smoking and healthier eating behavior.	Measured at baseline, 6 and 12 months follow-up	No
Secondary	Change in social support	We will measure this variable using the "Skala sozialer Unterstützung bei Krankheit (SSUK)". This instrument consists of two subscales, supportive behavior as well as stressful interactions.	Measured at baseline, 6 and 12 months follow-up	No
Secondary	Change in health locus of control	We will measure this variable using the "MHLC-C". This instrument consists of four subscales, internal, chance, doctors and other people.	Measured at baseline, 6 and 12 months follow-up	No
Secondary	Change in lifestyle behavior	This includes smoking, alcohol consumption, eating habits and physical activity.	Measured at baseline, 6 and 12 months follow-up	No
Secondary	Change in social network of family and friends	This includes the number of closer family members and friends and the amount of contact with them.	Measured at baseline, 6 and 12 months follow-up	No
Secondary	Change in outcome expectancies	This includes items regarding sports, quit smoking and healthier eating behavior.	Measured at baseline, 6 and 12 months follow-up	No
Secondary	Change in vulnerability	This includes the total vulnerability regarding specific diseases for one's own person as well as for a peer/other person. Thus the relative vulnerability can be determined.	Measured at baseline, 6 and 12 months follow-up	No
Secondary	Change in intention	This includes items of intentions for a healthier lifestyle like more physical activity, quit smoking and healthier eating behaviors.	Measured at baseline, 6 and 12 months follow-up	No
Secondary	Change in severity	This includes the estimated severity of different cardiovascular diseases in general as well as their severity for the own individual.	Measured at baseline, 6 and 12 months follow-up	No
Secondary	Change in health worries	This includes worries about the own health in general as well as regarding specific health problems like blood pressure, high cholesterol or the risk of a myocardial infarction.	Measured at baseline, 6 and 12 months follow-up	No
Secondary	Change in cognitive functions	This will be measured using the Mini-mental Status Exam and the Clock Drawing Test.	Measured at baseline, 6 and 12 months follow-up	No