diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)

Diabetes Mellitus, Type 2 Clinical Trial

— ENHANCED  

Official title:

diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02980978
• Other study ID #: ENHANCED
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: November 13, 2018

Study information

• Verified date: May 2019
• Source: Minneapolis Heart Institute Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: November 13, 2018
• Est. primary completion date: December 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Coaching
Focus on nutrition, activity and appropriate medication use and adherence

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Heart Institute Foundation	Academy of Nutrition and Dietetics

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings)	The count of participants represents the number of individuals meeting blood pressure less than 140/90 at follow up	1 year
Other	Tobacco Use (Self-reported Questionnaire)	The count of participants represents those not using tobacco at follow up	1 year
Other	Statin Use (as Noted in EMR)	The count of participants represents those taking a statin as indicated at follow up	1 year
Other	Aspirin Use (as Noted in EMR)	The count of participants represents taking aspirin as indicated at follow up	1 year
Primary	A1c (Laboratory Assessment)	The count of participants represents the number of individuals meeting A1c less than 8% at follow up	1 year