diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED) (ENHANCED)
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|ClinicalTrials.gov Identifier: NCT02980978|
Recruitment Status : Enrolling by invitation
First Posted : December 2, 2016
Last Update Posted : December 2, 2016
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 or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: Coaching||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2020|
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
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
- A1c (laboratory assessment) [ Time Frame: 1 year ]
- Weight in kg (calibrated scale) [ Time Frame: 1 year ]
- 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 ]
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
|Principal Investigator:||Michael Miedema, MD||Minneapolis Heart Institute Foundation|