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

May 30, 2019 updated by: Minneapolis Heart Institute Foundation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A1c (Laboratory Assessment)
Time Frame: 1 year
The count of participants represents the number of individuals meeting A1c less than 8% at follow up
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings)
Time Frame: 1 year
The count of participants represents the number of individuals meeting blood pressure less than 140/90 at follow up
1 year
Tobacco Use (Self-reported Questionnaire)
Time Frame: 1 year
The count of participants represents those not using tobacco at follow up
1 year
Statin Use (as Noted in EMR)
Time Frame: 1 year
The count of participants represents those taking a statin as indicated at follow up
1 year
Aspirin Use (as Noted in EMR)
Time Frame: 1 year
The count of participants represents taking aspirin as indicated at follow up
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minneapolis Heart Institute Foundation

Collaborators

Academy of Nutrition and Dietetics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

December 13, 2017

Study Completion (Actual)

November 13, 2018

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 2, 2016

Study Record Updates

Last Update Posted (Actual)

July 29, 2019

Last Update Submitted That Met QC Criteria

May 30, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENHANCED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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