Clinical trial NCT02980978: diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)
Official title: diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
Collaborators: name: Academy of Nutrition and Dietetics
First posted: 2016-12-02
Enrollment: 118
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility 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

Primary outcomes:
measure: A1c (Laboratory Assessment)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings)
timeFrame: 1 year
measure: Tobacco Use (Self-reported Questionnaire)
timeFrame: 1 year
measure: Statin Use (as Noted in EMR)
timeFrame: 1 year
measure: Aspirin Use (as Noted in EMR)
timeFrame: 1 year
Locations:
Study officials:
affiliation: Minneapolis Heart Institute Foundation
name: Michael Miedema, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.