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Empowerment and Support for the Diabetic Patient (CHANGE-D)

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Health Coaching
Sponsored by
Clalit Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Type II diabetes

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 2 diabetes
  • At least one oral anti diabetic drug
  • HbA1c above 7.5% ot above 0.5% of personal target
  • Preparedness for change
  • Fluent Hebrew or Arabic

Exclusion Criteria:

  • Type 1 diabetes
  • Pregnancy or lactation
  • Incompetency to sign consent
  • Participation in another clinical trial
  • Unstable psychotic disease
  • Complex health condition

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Health coaching

    Standard of Care

    Arm Description

    Patients receive health coaching via the phone, face to face or group support, according to patients' choice

    Outcomes

    Primary Outcome Measures

    Clinical composite
    Change from baseline in a composite endpoint of HbA1c, BMI, Blood Pressure, Lipids at 6, 12 and 18 months from randomization

    Secondary Outcome Measures

    Change in Self Treatment Score
    Change from baseline in Self treatment diabetes questionnaire score at 6, 12 and 18 months from randomization
    Change in Self Efficacy Score
    Change from baseline in Self Efficacy questionnaire score at 6, 12 and 18 months from randomization

    Full Information

    First Posted
    June 25, 2014
    Last Updated
    August 4, 2015
    Sponsor
    Clalit Health Services
    Collaborators
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02179385
    Brief Title
    Empowerment and Support for the Diabetic Patient
    Acronym
    CHANGE-D
    Official Title
    Coaching for Health to Achieve New Goals in Empowerment for Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    June 2016 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Clalit Health Services
    Collaborators
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    CHANGE-D objectives are to evaluate to what extent personal coaching for healthy lifestyle and treatment adherence improves clinical outcomes among uncontrolled diabetic patients. Evaluate to what extent personal coaching for healthy lifestyle and treatment adherence improves self treatment among uncontrolled diabetic patients.
    Detailed Description
    Research Group 300 type 2 diabetics: 150 from Jewish sector and 150 from Arab sector will be recruited from 7-10 clinics in each district: North District and Haifa District A personal coaching intervention will be tailored from the offered tools: Face to face, group, telephone Participants will be monitored for clinical and self treatments outcomes Comparison Group 300 patients with similar characteristics to the research group will receive Clalit's standard of care Participants will be monitored for clinical and self treatments outcomes like the research group

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes
    Keywords
    Type 2 diabetes, Type II diabetes

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Health coaching
    Arm Type
    Experimental
    Arm Description
    Patients receive health coaching via the phone, face to face or group support, according to patients' choice
    Arm Title
    Standard of Care
    Arm Type
    Placebo Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Health Coaching
    Primary Outcome Measure Information:
    Title
    Clinical composite
    Description
    Change from baseline in a composite endpoint of HbA1c, BMI, Blood Pressure, Lipids at 6, 12 and 18 months from randomization
    Time Frame
    0, 6, 12, 18 months from randomization
    Secondary Outcome Measure Information:
    Title
    Change in Self Treatment Score
    Description
    Change from baseline in Self treatment diabetes questionnaire score at 6, 12 and 18 months from randomization
    Time Frame
    0, 6, 12, 18 months from randomization
    Title
    Change in Self Efficacy Score
    Description
    Change from baseline in Self Efficacy questionnaire score at 6, 12 and 18 months from randomization
    Time Frame
    0, 6, 12, 18 months from randomization
    Other Pre-specified Outcome Measures:
    Title
    Change in Quality of life score
    Description
    Change from baseline in Diabetes Quality of Life questionnaire score at 12 months from randomization
    Time Frame
    0, 12 months from randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Type 2 diabetes At least one oral anti diabetic drug HbA1c above 7.5% ot above 0.5% of personal target Preparedness for change Fluent Hebrew or Arabic Exclusion Criteria: Type 1 diabetes Pregnancy or lactation Incompetency to sign consent Participation in another clinical trial Unstable psychotic disease Complex health condition

    12. IPD Sharing Statement

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    Empowerment and Support for the Diabetic Patient

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