Coronary Heart DiseaseKHK ProMANCT01725074
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)
A study testing Case Management "CM CHD" and Social Interaction in people with Coronary Heart Disease and Multimorbidity, run by Genossenschaft Gesundheitsprojekt Mannheim e.G at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Coronary Heart Disease, Multimorbidity
- What is being tested?
- Case Management "CM CHD" and Social Interaction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Genossenschaft Gesundheitsprojekt Mannheim e.G.
Mannheim, Baden-Wurttemberg, 68259
About this study
Official title: Koronare Herzkrankheit Projekt Mannheim
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.
Read the 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.
- Conditions
- Coronary Heart Disease, Multimorbidity
- Being tested
- Case Management "CM CHD", Social Interaction
- Keywords
- Coronary Heart Disease, multimorbidity, primary care, case management, loneliness, depression, social support
- Medical subject headings
- Coronary Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case Management "CM CHD"Behavioural
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 InteractionBehavioural
Identical as the CM CHD group, but with exclusion of medical control measures and the medical aspects.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Case Management "CM CHD" |
| Social Interaction | Experimental | Identical as the CM CHD group, but with exclusion of medical control measures. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: Measured at baseline, 6 and 12 months follow-up
Secondary outcomes (13)
Change in Loneliness
We will measure this variable using the "Hamburger Einsamkeits-Skala (HES)" a German version of the UCLA-Loneliness Scale.
Measured: 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: 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: 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: 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: Measured at baseline, 6 and 12 months follow-up
Change in lifestyle behavior
This includes smoking, alcohol consumption, eating habits and physical activity.
Measured: 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: 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: 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: 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: 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: 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: 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: Measured at baseline, 6 and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startJul 2011
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genossenschaft Gesundheitsprojekt Mannheim e.G
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, pfm medical Institute gGmbH, Germany, Heidelberg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725074
- Sponsor's protocol ID
- KHK ProMA
- Acronym
- KHK ProMA
- Status last verified
- Nov 2012
- First submitted
- 8 Nov 2012
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Koronare Herzkrankheit Projekt Mannheim
- ClinicalTrials.gov ID
- NCT01725074
- Acronym / sponsor ID
- KHK ProMA / KHK ProMA
- Conditions
- Coronary Heart Disease, Multimorbidity
- Keywords
- Coronary Heart Disease, multimorbidity, primary care, case management, loneliness, depression, social support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Genossenschaft Gesundheitsprojekt Mannheim e.GUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, pfm medical Institute gGmbH, Germany, Heidelberg University
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 12 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case Management "CM CHD" | Experimental | Behavioral: Case Management "CM CHD"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. |
| Social Interaction | Experimental | Behavioral: Social InteractionIdentical as the CM CHD group, but with exclusion of medical control measures. |
| 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). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed CHD
- two additional chronic diseases (multimorbid)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Case Management "CM CHD" |
| Social InteractionIdentical as the CM CHD group, but with exclusion of medical control measures and the medical aspects. | Behavioural | Social Interaction |
Primary outcome
Change in health outcomes
Time frame: Measured at baseline, 6 and 12 months follow-up
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.
Change in quality of life
Time frame: Measured at baseline, 6 and 12 months follow-up
We will measure this variable using the "EQ-5D" and two additional items.
13 secondary outcomes
Change in Loneliness
Time frame: Measured at baseline, 6 and 12 months follow-up
Change in Depression
Time frame: Measured at baseline, 6 and 12 months follow-up
Change in self-efficacy
Time frame: Measured at baseline, 6 and 12 months follow-up
Change in social support
Time frame: Measured at baseline, 6 and 12 months follow-up
Change in health locus of control
Time frame: Measured at baseline, 6 and 12 months follow-up
Change in lifestyle behavior
Time frame: Measured at baseline, 6 and 12 months follow-up
Change in social network of family and friends
Time frame: Measured at baseline, 6 and 12 months follow-up
Change in outcome expectancies
Time frame: Measured at baseline, 6 and 12 months follow-up
Change in vulnerability
Time frame: Measured at baseline, 6 and 12 months follow-up
Change in intention
Time frame: Measured at baseline, 6 and 12 months follow-up
Change in severity
Time frame: Measured at baseline, 6 and 12 months follow-up
Change in health worries
Time frame: Measured at baseline, 6 and 12 months follow-up
Change in cognitive functions
Time frame: Measured at baseline, 6 and 12 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case Management "CM CHD" and Social Interaction in people with Coronary Heart Disease and Multimorbidity, run by Genossenschaft Gesundheitsprojekt Mannheim e.G at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health outcomes (time frame: Measured at baseline, 6 and 12 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2012.