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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980978
First Posted: December 2, 2016
Last Update Posted: December 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Academy of Nutrition and Dietetics
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2 Behavioral: Coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)

Further study details as provided by Minneapolis Heart Institute Foundation:

Primary Outcome Measures:
  • A1c (laboratory assessment) [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Weight in kg (calibrated scale) [ Time Frame: 1 year ]

Other Outcome Measures:
  • Blood Pressure (calibrated cuff measurement- average of 3 readings) [ Time Frame: 1 year ]
  • Tobacco use (self-reported questionnaire) [ Time Frame: 1 year ]
  • Statin use (as noted in EMR) [ Time Frame: 1 year ]
  • Aspirin use (as noted in EMR) [ Time Frame: 1 year ]

Estimated Enrollment: 144
Study Start Date: April 2016
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
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
Behavioral: Coaching
Focus on nutrition, activity and appropriate medication use and adherence
No Intervention: Standard of Care
Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980978


Sponsors and Collaborators
Minneapolis Heart Institute Foundation
Academy of Nutrition and Dietetics
Investigators
Principal Investigator: Michael Miedema, MD Minneapolis Heart Institute Foundation
  More Information

Responsible Party: Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier: NCT02980978     History of Changes
Other Study ID Numbers: ENHANCED
First Submitted: November 15, 2016
First Posted: December 2, 2016
Last Update Posted: December 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases