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Completed

NCT Number: NCT02980978

diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

coaching

Behavioral

Focus on nutrition, activity and appropriate medication use and adherence

Primary outcomes

  1. A1c (Laboratory Assessment)

    Time frame: 1 year

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

Other outcomes

  1. 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

  2. Tobacco Use (Self-reported Questionnaire)

    Time frame: 1 year

    The count of participants represents those not using tobacco at follow up

  3. Statin Use (as Noted in EMR)

    Time frame: 1 year

    The count of participants represents those taking a statin as indicated at follow up

  4. Aspirin Use (as Noted in EMR)

    Time frame: 1 year

    The count of participants represents taking aspirin as indicated at follow up

Sponsors and collaborators

Lead sponsor

Minneapolis Heart Institute Foundation

Other

Collaborators

  • Academy of Nutrition and Dietetics

Registry information

Acronym: ENHANCED

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 2, 2016
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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