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diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED) (ENHANCED)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Coaching
Sponsored by
Minneapolis Heart Institute Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Diagnosis of Type 2 Diabetes
  2. Individuals who are not meeting 3 or more D5 goals,
  3. Have had a visit with a provider within the last 2 years

Exclusion Criteria:

  1. Type 1 Diabetes
  2. Chronic kidney disease (GFR <30)
  3. HIV
  4. Institutional residence
  5. Major cognitive or language barrier (as determined by program enrollment staff)
  6. Other active end-stage disease (e.g., late stage cancer or pulmonary disease)
  7. Actively receiving cancer treatment
  8. Pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Standard of Care

    Arm Description

    Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals

    Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need

    Outcomes

    Primary Outcome Measures

    A1c (Laboratory Assessment)
    The count of participants represents the number of individuals meeting A1c less than 8% at follow up

    Secondary Outcome Measures

    Full Information

    First Posted
    November 15, 2016
    Last Updated
    May 30, 2019
    Sponsor
    Minneapolis Heart Institute Foundation
    Collaborators
    Academy of Nutrition and Dietetics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02980978
    Brief Title
    diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)
    Acronym
    ENHANCED
    Official Title
    diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2016 (undefined)
    Primary Completion Date
    December 13, 2017 (Actual)
    Study Completion Date
    November 13, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Minneapolis Heart Institute Foundation
    Collaborators
    Academy of Nutrition and Dietetics

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to randomly assign individuals with type 2 diabetes into the ENHANCED randomized control trial. The study is being conducted by the Minneapolis Heart Institute Foundation (MHIF) and will have two study sites 1) Hutchinson Health and 2) New Ulm Medical Center. The study is primarily funded through the Academy of Nutrition and Dietetics (AND). The study will examine the impact of a registered dietitian-led, primary care integrated, telemedicine program on diabetes care measures (the 'D5') over one year as compared to usual care. The D5 goals include: blood pressure <140/90 mmHg, taking a statin as appropriate, A1c <8%, not using tobacco and taking an aspirin as appropriate.
    Detailed Description
    Individuals will be invited to attend a baseline visit where they will have lab work done, anthropometrics (height, weight, waist circumference) and complete a lifestyle assessment. They will formally consent to participation by signing a study consent form. The same measures will be collected after completion of the one year study. Study participants will receive two sessions of free lab work, a diabetes education book, and brief coaching with a registered dietitian/certified diabetes educator. In addition, those randomized to the phone coaching will have access to a registered dietitian/certified diabetes educator on a monthly basis for one year of personalized health coaching for free. The intent of this coaching is to help individuals achieve diabetes "optimal" care or meeting all 5 Diabetes Care measures (blood glucose, blood pressure, tobacco use, statin and aspirin use). This program is designed to complement usual clinic-based primary care, with coaches documenting lab, biometrics and medication adjustments in the EHR, along with documenting phone encounters and communicating directly with patients' PCPs as needed. Documentation in the EHR uses an order created specifically for the study indicating the patient's research status. Lab work required as part of this research study at baseline and 12 months is covered by the study. Any lab work and/or medication co-pays or fees outside of the baseline and 12 month study visits are the responsibility of the patient and/or their insurance

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals
    Arm Title
    Standard of Care
    Arm Type
    No Intervention
    Arm Description
    Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
    Intervention Type
    Behavioral
    Intervention Name(s)
    Coaching
    Intervention Description
    Focus on nutrition, activity and appropriate medication use and adherence
    Primary Outcome Measure Information:
    Title
    A1c (Laboratory Assessment)
    Description
    The count of participants represents the number of individuals meeting A1c less than 8% at follow up
    Time Frame
    1 year
    Other Pre-specified Outcome Measures:
    Title
    Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings)
    Description
    The count of participants represents the number of individuals meeting blood pressure less than 140/90 at follow up
    Time Frame
    1 year
    Title
    Tobacco Use (Self-reported Questionnaire)
    Description
    The count of participants represents those not using tobacco at follow up
    Time Frame
    1 year
    Title
    Statin Use (as Noted in EMR)
    Description
    The count of participants represents those taking a statin as indicated at follow up
    Time Frame
    1 year
    Title
    Aspirin Use (as Noted in EMR)
    Description
    The count of participants represents taking aspirin as indicated at follow up
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of Type 2 Diabetes Individuals who are not meeting 3 or more D5 goals, Have had a visit with a provider within the last 2 years Exclusion Criteria: Type 1 Diabetes Chronic kidney disease (GFR <30) HIV Institutional residence Major cognitive or language barrier (as determined by program enrollment staff) Other active end-stage disease (e.g., late stage cancer or pulmonary disease) Actively receiving cancer treatment Pregnant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Miedema, MD
    Organizational Affiliation
    Minneapolis Heart Institute Foundation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30711463
    Citation
    Benson GA, Sidebottom A, Hayes J, Miedema MD, Boucher J, Vacquier M, Sillah A, Gamam S, VanWormer JJ. Impact of ENHANCED (diEtitiaNs Helping pAtieNts CarE for Diabetes) Telemedicine Randomized Controlled Trial on Diabetes Optimal Care Outcomes in Patients with Type 2 Diabetes. J Acad Nutr Diet. 2019 Apr;119(4):585-598. doi: 10.1016/j.jand.2018.11.013. Epub 2019 Jan 31.
    Results Reference
    derived

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