<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01725074</url>
  </required_header>
  <id_info>
    <org_study_id>KHK ProMA</org_study_id>
    <nct_id>NCT01725074</nct_id>
  </id_info>
  <brief_title>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)</brief_title>
  <acronym>KHK ProMA</acronym>
  <official_title>Koronare Herzkrankheit Projekt Mannheim</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genossenschaft Gesundheitsprojekt Mannheim e.G</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>pfm medical Institute gGmbH, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Heidelberg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Genossenschaft Gesundheitsprojekt Mannheim e.G</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled trial (RCT) will examine a case management program for patients&#xD;
      suffering from coronary heart disease with multimorbidity in Mannheim, Germany. The trail&#xD;
      consists of 3 treatment arms: 1) intensified case management; 2) social interaction alone 3)&#xD;
      standard care. The main objectives are to evaluate how case management and social interaction&#xD;
      alone compared to standard medical care affect the primary and secondary outcomes: physical&#xD;
      health, quality of life, loneliness, depression, self-efficacy, outcome expectancies, social&#xD;
      support, health locus of control, lifestyle behavior, social network, vulnerability,&#xD;
      intention, severity, health worries and cognitive functions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized controlled trial (RCT) will examine a case management program for 320 male&#xD;
      and female patients suffering from coronary heart disease with multimorbidity in Mannheim,&#xD;
      Germany. The main objectives are to evaluate how case management and social interaction alone&#xD;
      compared to standard medical care affect the primary and secondary outcomes: physical health,&#xD;
      quality of life, loneliness, depression, self-efficacy, outcome expectancies, social support,&#xD;
      health locus of control, lifestyle behavior, social network, vulnerability, intention,&#xD;
      severity, health worries and cognitive functions.&#xD;
&#xD;
      Additionally, the secondary outcomes are studied as factors that mediate the effects of case&#xD;
      management and social interaction alone compared to standard medical care on the primary&#xD;
      outcomes.&#xD;
&#xD;
      The trail consists of 3 treatment arms: 1) intensified case management; 2) social interaction&#xD;
      alone 3) usual care. The intervention consists of a biweekly contact by trained case managers&#xD;
      over the first 6-months and a monthly contact over the subsequent 6-months. Each contact&#xD;
      involves an assessment of well-being, daily life, problems and offering emotional support and&#xD;
      solutions or refer to the general practitioner if necessary (both intervention groups).&#xD;
&#xD;
      For patients assigned to the &quot;CM CHD&quot; the contacts include medical control (like blood&#xD;
      pressure or weight) and well-being as well as an additional core set of relevant outcome&#xD;
      measures (e.g. need for treatment of fatigue).&#xD;
&#xD;
      Patients assigned to the control group received usual care (no CM or contact). An additional&#xD;
      fourth group is monitored. This group is consisting of patients who refused to take part in&#xD;
      the study but gave consent to collect their practice data (not randomized).&#xD;
&#xD;
      Each patient will be followed for 12 months. Extensive assessments and self-administered&#xD;
      questionnaires take place at baseline, 6-month and 12-month for all patients in the three&#xD;
      randomized groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2011</start_date>
  <completion_date type="Anticipated">March 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in health outcomes</measure>
    <time_frame>Measured at baseline, 6 and 12 months follow-up</time_frame>
    <description>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).&#xD;
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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>Measured at baseline, 6 and 12 months follow-up</time_frame>
    <description>We will measure this variable using the &quot;EQ-5D&quot; and two additional items.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Loneliness</measure>
    <time_frame>Measured at baseline, 6 and 12 months follow-up</time_frame>
    <description>We will measure this variable using the &quot;Hamburger Einsamkeits-Skala (HES)&quot; a German version of the UCLA-Loneliness Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression</measure>
    <time_frame>Measured at baseline, 6 and 12 months follow-up</time_frame>
    <description>We will measure this variable using the &quot;Patient Health Questionnaire - 9 item (PHQ-9) instrument&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-efficacy</measure>
    <time_frame>Measured at baseline, 6 and 12 months follow-up</time_frame>
    <description>We will measure this variable using the &quot;SWE&quot; questionnaire as well as items of self-efficacy regarding sports, quit smoking and healthier eating behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in social support</measure>
    <time_frame>Measured at baseline, 6 and 12 months follow-up</time_frame>
    <description>We will measure this variable using the &quot;Skala sozialer Unterstützung bei Krankheit (SSUK)&quot;. This instrument consists of two subscales, supportive behavior as well as stressful interactions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health locus of control</measure>
    <time_frame>Measured at baseline, 6 and 12 months follow-up</time_frame>
    <description>We will measure this variable using the &quot;MHLC-C&quot;. This instrument consists of four subscales, internal, chance, doctors and other people.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lifestyle behavior</measure>
    <time_frame>Measured at baseline, 6 and 12 months follow-up</time_frame>
    <description>This includes smoking, alcohol consumption, eating habits and physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in social network of family and friends</measure>
    <time_frame>Measured at baseline, 6 and 12 months follow-up</time_frame>
    <description>This includes the number of closer family members and friends and the amount of contact with them.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in outcome expectancies</measure>
    <time_frame>Measured at baseline, 6 and 12 months follow-up</time_frame>
    <description>This includes items regarding sports, quit smoking and healthier eating behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in vulnerability</measure>
    <time_frame>Measured at baseline, 6 and 12 months follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in intention</measure>
    <time_frame>Measured at baseline, 6 and 12 months follow-up</time_frame>
    <description>This includes items of intentions for a healthier lifestyle like more physical activity, quit smoking and healthier eating behaviors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in severity</measure>
    <time_frame>Measured at baseline, 6 and 12 months follow-up</time_frame>
    <description>This includes the estimated severity of different cardiovascular diseases in general as well as their severity for the own individual.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health worries</measure>
    <time_frame>Measured at baseline, 6 and 12 months follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive functions</measure>
    <time_frame>Measured at baseline, 6 and 12 months follow-up</time_frame>
    <description>This will be measured using the Mini-mental Status Exam and the Clock Drawing Test.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">320</enrollment>
  <condition>Coronary Heart Disease</condition>
  <condition>Multimorbidity</condition>
  <arm_group>
    <arm_group_label>Case Management &quot;CM CHD&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Social Interaction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Identical as the CM CHD group, but with exclusion of medical control measures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Case Management &quot;CM CHD&quot;</intervention_name>
    <description>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:&#xD;
Biweekly/monthly telephone consultations or home visits&#xD;
Identification of health or personal problems of the patient&#xD;
Monitoring of medical parameters&#xD;
Coordination of contact with health care providers if necessary&#xD;
Support to the patient related to health status and environmental changes&#xD;
Promote disease-self management through coaching&#xD;
Counseling, that is focused on emotional support and active listening</description>
    <arm_group_label>Case Management &quot;CM CHD&quot;</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social Interaction</intervention_name>
    <description>Identical as the CM CHD group, but with exclusion of medical control measures and the medical aspects.</description>
    <arm_group_label>Social Interaction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed CHD&#xD;
&#xD;
               -  participation in the Disease Management Program (DMP) of CHD or&#xD;
&#xD;
               -  a risk score (Framingham or Procam) higher than 20%&#xD;
&#xD;
          -  two additional chronic diseases (multimorbid)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients living in institutionalized care&#xD;
&#xD;
          -  Patients having dementia&#xD;
&#xD;
          -  Patients associated with a life expectancy of less than one year&#xD;
&#xD;
          -  Patients who are not able to communicate in German language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Genossenschaft Gesundheitsprojekt Mannheim e.G.</name>
      <address>
        <city>Mannheim</city>
        <state>BW</state>
        <zip>68259</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>November 9, 2012</last_update_submitted>
  <last_update_submitted_qc>November 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary Heart Disease, multimorbidity, primary care, case management, loneliness, depression, social support</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01725074
org study id: KHK ProMA
nct id: NCT01725074
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in health outcomes
time frame: Measured at baseline, 6 and 12 months follow-up
description: 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.
measure: Change in quality of life
time frame: Measured at baseline, 6 and 12 months follow-up
description: We will measure this variable using the "EQ-5D" and two additional items.
measure: Change in Loneliness
time frame: Measured at baseline, 6 and 12 months follow-up
description: We will measure this variable using the "Hamburger Einsamkeits-Skala (HES)" a German version of the UCLA-Loneliness Scale.
measure: Change in Depression
time frame: Measured at baseline, 6 and 12 months follow-up
description: We will measure this variable using the "Patient Health Questionnaire - 9 item (PHQ-9) instrument".
measure: Change in self-efficacy
time frame: Measured at baseline, 6 and 12 months follow-up
description: We will measure this variable using the "SWE" questionnaire as well as items of self-efficacy regarding sports, quit smoking and healthier eating behavior.
measure: Change in social support
time frame: Measured at baseline, 6 and 12 months follow-up
description: 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.
measure: Change in health locus of control
time frame: Measured at baseline, 6 and 12 months follow-up
description: We will measure this variable using the "MHLC-C". This instrument consists of four subscales, internal, chance, doctors and other people.
measure: Change in lifestyle behavior
time frame: Measured at baseline, 6 and 12 months follow-up
description: This includes smoking, alcohol consumption, eating habits and physical activity.
measure: Change in social network of family and friends
time frame: Measured at baseline, 6 and 12 months follow-up
description: This includes the number of closer family members and friends and the amount of contact with them.
measure: Change in outcome expectancies
time frame: Measured at baseline, 6 and 12 months follow-up
description: This includes items regarding sports, quit smoking and healthier eating behavior.
measure: Change in vulnerability
time frame: Measured at baseline, 6 and 12 months follow-up
description: 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.
measure: Change in intention
time frame: Measured at baseline, 6 and 12 months follow-up
description: This includes items of intentions for a healthier lifestyle like more physical activity, quit smoking and healthier eating behaviors.
measure: Change in severity
time frame: Measured at baseline, 6 and 12 months follow-up
description: This includes the estimated severity of different cardiovascular diseases in general as well as their severity for the own individual.
measure: Change in health worries
time frame: Measured at baseline, 6 and 12 months follow-up
description: 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.
measure: Change in cognitive functions
time frame: Measured at baseline, 6 and 12 months follow-up
description: This will be measured using the Mini-mental Status Exam and the Clock Drawing Test.
arm group label: Case Management "CM CHD"
arm group type: Experimental
description: 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.
arm group label: Social Interaction
arm group type: Experimental
description: Identical as the CM CHD group, but with exclusion of medical control measures.
arm group label: Control Group
arm group type: No Intervention
description: 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).
intervention type: Behavioral
intervention name: Case Management "CM CHD"
description: 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
arm group label: Case Management "CM CHD"
intervention type: Behavioral
intervention name: Social Interaction
description: Identical as the CM CHD group, but with exclusion of medical control measures and the medical aspects.
arm group label: Social Interaction
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia