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)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Koronare Herzkrankheit Projekt Mannheim

Conditions
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Coronary Heart Disease, Multimorbidity

Intervention / Treatment
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* Behavioral: Case Management CM CHD
* Behavioral: Social Interaction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case Management CM CHD<br>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. | Behavioral: Case Management CM CHD<br>* 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<br>|
| Experimental: Social Interaction<br>Identical as the CM CHD group, but with exclusion of medical control measures. | Behavioral: Social Interaction<br>* Identical as the CM CHD group, but with exclusion of medical control measures and the medical aspects.<br>|
| No Intervention: Control Group<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Change in lifestyle behavior | This includes smoking, alcohol consumption, eating habits and physical activity. | Measured at baseline, 6 and 12 months follow-up | 
| 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 | 
| Change in outcome expectancies | This includes items regarding sports, quit smoking and healthier eating behavior. | Measured at baseline, 6 and 12 months follow-up | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Heart Disease, multimorbidity, primary care, case management, loneliness, depression, social support