<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/NCT02258516</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00019792</org_study_id>
    <secondary_id>1R03NR011500-01</secondary_id>
    <nct_id>NCT02258516</nct_id>
  </id_info>
  <brief_title>A Randomized Study of the Efficacy of a New Intervention for Medication Adherence in Chronic Illness: Medications, Meaning and Me (The 3-M Study)</brief_title>
  <official_title>A Randomized Study of the Efficacy of a New Intervention for Medication Adherence in Chronic Illness: Medications, Meaning and Me (The 3-M Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of the study - The purpose of this study is to develop and evaluate the efficacy of a&#xD;
      new, theoretically based intervention to improve medication adherence in persons with HF. The&#xD;
      hypotheses include:&#xD;
&#xD;
      Hypothesis I. Poorly adherent patients with symptomatic HF who receive the intervention&#xD;
      (n=40) will be more adherent to medicines during the12-month intervention than a control&#xD;
      group (n=40) of poorly adherent patients with symptomatic HF.&#xD;
&#xD;
      Hypothesis II. Poorly adherent patients with symptomatic HF who receive the intervention&#xD;
      (n=40) will have fewer hospital readmissions (HR) and emergency department (ED) visits during&#xD;
      the 12-month intervention than a control group of poorly adherent patients with symptomatic&#xD;
      HF.&#xD;
&#xD;
      Study Activities and population - A prospective, randomized controlled design will be used to&#xD;
      pilot test the efficacy of a new intervention to promote adherence to the medication regimen&#xD;
      in chronic heart failure in the clinical setting. The initial development and feasibility&#xD;
      testing of the intervention is complete (Preliminary Work, Section 4.5).&#xD;
&#xD;
      Patients with HF symptom exacerbation (n = 80) who exhibit high likelihood of poor adherence,&#xD;
      as determined by a validated screening measure, the Medication Adherence Scale (MAS)89 at&#xD;
      baseline assessment, will be recruited and randomized to receive the intervention or usual&#xD;
      care with attention control. Medication adherence, symptom frequency and intensity, hospital&#xD;
      readmissions (HR) and emergency department (ED) visits will be assessed in both groups at 3,&#xD;
      6 and 12-month clinic visits. The intervals between visits are considered sufficient to&#xD;
      minimize sensitization bias to psychometric measures. Longitudinal measurement is required to&#xD;
      evaluate the magnitude of change in adherence and symptom-related events occurring over time.&#xD;
      Efficacy will be measured as improved adherence (primary outcome) and decreased HR and ED&#xD;
      visits (secondary outcomes) in the intervention group as compared to the attention control&#xD;
      group at 12 months. The study will close when all patients have had a 12-month&#xD;
      post-enrollment clinic visit.&#xD;
&#xD;
      Data Analysis &amp; Safety/Risk Considerations - The investigators will use generalized linear&#xD;
      models to test the primary and secondary hypotheses (McCullagh and Nelder, 1989). Logistic&#xD;
      generalizations of the traditional, multivariate GLM are appropriate when the dependent&#xD;
      variable is binary and the probability of an event is modeled, as is the case with adherence&#xD;
      in this study. When the dependent variable is a count, a commonly used generalized model uses&#xD;
      the natural logarithm of the count, as with re-hospitalizations and ED visits in this study.&#xD;
      In compliance with NIH guidelines for data safety and monitoring activities, a number of&#xD;
      quality control steps will be used to ensure the on-going safety of participants and the&#xD;
      scientific integrity of this feasibility intervention study. The proposed study poses only&#xD;
      very minimal risks to participants. All participants will receive usual care. Participation&#xD;
      in the study will not replace patients' regular health care attention. Data safety will be&#xD;
      monitored by the PI, the Data Safety Officer (Dr. Karl Swedberg), and the study&#xD;
      co-investigators. Any adverse events will be reported immediately to the Duke IRB and the&#xD;
      NIH.&#xD;
&#xD;
      Data Safety. First, a project database will be constructed, using participant ID numbers and&#xD;
      including all demographic, pre- and post-intervention history and all assessment materials. A&#xD;
      separate file, cross-referencing participant identification with project ID numbers, will be&#xD;
      maintained with access limited to the PI or a designated member of the investigative team.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in medication adherence</measure>
    <time_frame>baseline (0), 3, 6, and 12 months</time_frame>
    <description>Nurse-observed pill count, the primary measure of adherence, was collected at baseline (0), 3, 6, and 12 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in medication adherence based on the MAS</measure>
    <time_frame>baseline (0), 3, 6, and 12 months</time_frame>
    <description>The study team also collected the Morisky Medication Adherence Scale (MAS) at baseline (0), 3, 6, and 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in belief in medications</measure>
    <time_frame>baseline (0), 3, 6, and 12 months</time_frame>
    <description>Horne &quot;Belief in Medications Questionnaire&quot; (BMQ) was collected at baseline (0), 3,6, and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in symptom frequency</measure>
    <time_frame>baseline (0), 3,6, and 12 months</time_frame>
    <description>count of patient-reported symptom onset was collected at baseline (0), 3,6, and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in hospital readmissions</measure>
    <time_frame>baseline (0), 3, 6, and 12 months</time_frame>
    <description>Readmissions were reviewed with patients at baseline (0), 3, 6, and 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in Emergency Department visits</measure>
    <time_frame>baseline (0), 3, 6 and 12 months</time_frame>
    <description>Emergency department visits were reviewed with patients at baseline (0), 3, 6 and 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in satisfaction with Information about Medicines (SIMS)</measure>
    <time_frame>baseline (0), 3, 6, and 12 months</time_frame>
    <description>The questionnaire &quot;satisfaction with information about medicines&quot; was collected at baseline (0), 3, 6, and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in Kansas City Cardiomyopathy Questionnaire (KCCQ)</measure>
    <time_frame>baseline (0), 3, 6, and 12 months</time_frame>
    <description>The questionnaire &quot;KCCQ&quot; was collected at baseline (0), 3, 6, and 12 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Self-management in Heart Failure</condition>
  <arm_group>
    <arm_group_label>behavioral intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient education for self-management called &quot;CHIME 3-M&quot; will be delivered</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>attention control arm received phone calls to discuss non-heart failure related health topics</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CHIME 3-M</intervention_name>
    <description>behavioral intervention for self-management in heart failure</description>
    <arm_group_label>behavioral intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>attention control</intervention_name>
    <description>patients will receive phone calls regarding health-related topics not associated with heart failure</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 18 years old&#xD;
&#xD;
          -  symptomatic heart failure&#xD;
&#xD;
          -  telephone required&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  heart failure due to congenital etiology&#xD;
&#xD;
          -  patients who cannot provide self-care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>bradi b granger, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University School of Nursing</affiliation>
  </overall_official>
  <reference>
    <citation>Granger BB, Ekman I, Hernandez AF, Sawyer T, Bowers MT, DeWald TA, Zhao Y, Levy J, Bosworth HB. Results of the Chronic Heart Failure Intervention to Improve MEdication Adherence study: A randomized intervention in high-risk patients. Am Heart J. 2015 Apr;169(4):539-48. doi: 10.1016/j.ahj.2015.01.006. Epub 2015 Jan 14.</citation>
    <PMID>25819861</PMID>
  </reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>August 19, 2016</last_update_submitted>
  <last_update_submitted_qc>August 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</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/NCT02258516
org study id: Pro00019792
secondary id: 1R03NR011500-01
nct id: NCT02258516
lead sponsor: 
collaborator: 
has dmc: No
Purpose of the study - The purpose of this study is to develop and evaluate the efficacy of a
      new, theoretically based intervention to improve medication adherence in persons with HF. The
      hypotheses include:

      Hypothesis I. Poorly adherent patients with symptomatic HF who receive the intervention
      (n=40) will be more adherent to medicines during the12-month intervention than a control
      group (n=40) of poorly adherent patients with symptomatic HF.

      Hypothesis II. Poorly adherent patients with symptomatic HF who receive the intervention
      (n=40) will have fewer hospital readmissions (HR) and emergency department (ED) visits during
      the 12-month intervention than a control group of poorly adherent patients with symptomatic
      HF.

      Study Activities and population - A prospective, randomized controlled design will be used to
      pilot test the efficacy of a new intervention to promote adherence to the medication regimen
      in chronic heart failure in the clinical setting. The initial development and feasibility
      testing of the intervention is complete (Preliminary Work, Section 4.5).

      Patients with HF symptom exacerbation (n = 80) who exhibit high likelihood of poor adherence,
      as determined by a validated screening measure, the Medication Adherence Scale (MAS)89 at
      baseline assessment, will be recruited and randomized to receive the intervention or usual
      care with attention control. Medication adherence, symptom frequency and intensity, hospital
      readmissions (HR) and emergency department (ED) visits will be assessed in both groups at 3,
      6 and 12-month clinic visits. The intervals between visits are considered sufficient to
      minimize sensitization bias to psychometric measures. Longitudinal measurement is required to
      evaluate the magnitude of change in adherence and symptom-related events occurring over time.
      Efficacy will be measured as improved adherence (primary outcome) and decreased HR and ED
      visits (secondary outcomes) in the intervention group as compared to the attention control
      group at 12 months. The study will close when all patients have had a 12-month
      post-enrollment clinic visit.

      Data Analysis & Safety/Risk Considerations - The investigators will use generalized linear
      models to test the primary and secondary hypotheses (McCullagh and Nelder, 1989). Logistic
      generalizations of the traditional, multivariate GLM are appropriate when the dependent
      variable is binary and the probability of an event is modeled, as is the case with adherence
      in this study. When the dependent variable is a count, a commonly used generalized model uses
      the natural logarithm of the count, as with re-hospitalizations and ED visits in this study.
      In compliance with NIH guidelines for data safety and monitoring activities, a number of
      quality control steps will be used to ensure the on-going safety of participants and the
      scientific integrity of this feasibility intervention study. The proposed study poses only
      very minimal risks to participants. All participants will receive usual care. Participation
      in the study will not replace patients' regular health care attention. Data safety will be
      monitored by the PI, the Data Safety Officer (Dr. Karl Swedberg), and the study
      co-investigators. Any adverse events will be reported immediately to the Duke IRB and the
      NIH.

      Data Safety. First, a project database will be constructed, using participant ID numbers and
      including all demographic, pre- and post-intervention history and all assessment materials. A
      separate file, cross-referencing participant identification with project ID numbers, will be
      maintained with access limited to the PI or a designated member of the investigative team.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: change in medication adherence
time frame: baseline (0), 3, 6, and 12 months
description: Nurse-observed pill count, the primary measure of adherence, was collected at baseline (0), 3, 6, and 12 months.
measure: change in medication adherence based on the MAS
time frame: baseline (0), 3, 6, and 12 months
description: The study team also collected the Morisky Medication Adherence Scale (MAS) at baseline (0), 3, 6, and 12 months.
measure: change in belief in medications
time frame: baseline (0), 3, 6, and 12 months
description: Horne "Belief in Medications Questionnaire" (BMQ) was collected at baseline (0), 3,6, and 12 months
measure: change in symptom frequency
time frame: baseline (0), 3,6, and 12 months
description: count of patient-reported symptom onset was collected at baseline (0), 3,6, and 12 months
measure: change in hospital readmissions
time frame: baseline (0), 3, 6, and 12 months
description: Readmissions were reviewed with patients at baseline (0), 3, 6, and 12 months.
measure: change in Emergency Department visits
time frame: baseline (0), 3, 6 and 12 months
description: Emergency department visits were reviewed with patients at baseline (0), 3, 6 and 12 months.
measure: change in satisfaction with Information about Medicines (SIMS)
time frame: baseline (0), 3, 6, and 12 months
description: The questionnaire "satisfaction with information about medicines" was collected at baseline (0), 3, 6, and 12 months
measure: change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
time frame: baseline (0), 3, 6, and 12 months
description: The questionnaire "KCCQ" was collected at baseline (0), 3, 6, and 12 months
arm group label: behavioral intervention
arm group type: Experimental
description: Patient education for self-management called "CHIME 3-M" will be delivered
arm group label: control
arm group type: Active Comparator
description: attention control arm received phone calls to discuss non-heart failure related health topics
intervention type: Behavioral
intervention name: CHIME 3-M
description: behavioral intervention for self-management in heart failure
arm group label: behavioral intervention
intervention type: Behavioral
intervention name: attention control
description: patients will receive phone calls regarding health-related topics not associated with heart failure
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: bradi b granger, PhD
role: Principal Investigator
affiliation: Duke University School of Nursing
citation: Granger BB, Ekman I, Hernandez AF, Sawyer T, Bowers MT, DeWald TA, Zhao Y, Levy J, Bosworth HB. Results of the Chronic Heart Failure Intervention to Improve MEdication Adherence study: A randomized intervention in high-risk patients. Am Heart J. 2015 Apr;169(4):539-48. doi: 10.1016/j.ahj.2015.01.006. Epub 2015 Jan 14.
PMID: 25819861
responsible party type: Sponsor
mesh term: Chronic Disease