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)

NCT01725074 | Unknown

• 1 other identifier: KHK ProMA
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease; Multimorbidity

Keywords

Coronary Heart Disease, multimorbidity, primary care, case management, loneliness, depression, social support

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Change in Loneliness

  Measured at baseline, 6 and 12 months follow-up

• Change in Depression

  Measured at baseline, 6 and 12 months follow-up

• Change in self-efficacy

  Measured at baseline, 6 and 12 months follow-up

• Change in social support

  Measured at baseline, 6 and 12 months follow-up

• Change in health locus of control

  Measured at baseline, 6 and 12 months follow-up

Study Arms (3)

Case Management "CM CHD"

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.

Behavioral: Case Management "CM CHD"

Social Interaction

EXPERIMENTAL

Identical as the CM CHD group, but with exclusion of medical control measures.

Behavioral: Social Interaction

Control Group

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).

Interventions

Case Management "CM CHD" BEHAVIORAL

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

Case Management "CM CHD"

Social Interaction BEHAVIORAL

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

Social Interaction

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Genossenschaft Gesundheitsprojekt Mannheim e.G: lead
• Merck Sharp & Dohme LLC: collaborator
• pfm medical Institute gGmbH, Germany: collaborator
• Heidelberg University: collaborator

Study Sites (1)

Genossenschaft Gesundheitsprojekt Mannheim e.G.

Mannheim, Baden-Wurttemberg, 68259, Germany

Location

MeSH Terms

Conditions

Coronary Disease; Depression

Interventions

Drug Interactions

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Pharmacological Phenomena; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 12, 2012
• Study Start: July 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: November 12, 2012

Record last verified: 2012-11

Locations

DE (1)