diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED) (ENHANCED)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Coaching
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Standard of Care
Arm Description
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
Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
Outcomes
Primary Outcome Measures
A1c (Laboratory Assessment)
The count of participants represents the number of individuals meeting A1c less than 8% at follow up
Secondary Outcome Measures
Full Information
NCT ID
NCT02980978
First Posted
November 15, 2016
Last Updated
May 30, 2019
Sponsor
Minneapolis Heart Institute Foundation
Collaborators
Academy of Nutrition and Dietetics
1. Study Identification
Unique Protocol Identification Number
NCT02980978
Brief Title
diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)
Acronym
ENHANCED
Official Title
diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 13, 2017 (Actual)
Study Completion Date
November 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minneapolis Heart Institute Foundation
Collaborators
Academy of Nutrition and Dietetics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
Intervention Type
Behavioral
Intervention Name(s)
Coaching
Intervention Description
Focus on nutrition, activity and appropriate medication use and adherence
Primary Outcome Measure Information:
Title
A1c (Laboratory Assessment)
Description
The count of participants represents the number of individuals meeting A1c less than 8% at follow up
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings)
Description
The count of participants represents the number of individuals meeting blood pressure less than 140/90 at follow up
Time Frame
1 year
Title
Tobacco Use (Self-reported Questionnaire)
Description
The count of participants represents those not using tobacco at follow up
Time Frame
1 year
Title
Statin Use (as Noted in EMR)
Description
The count of participants represents those taking a statin as indicated at follow up
Time Frame
1 year
Title
Aspirin Use (as Noted in EMR)
Description
The count of participants represents taking aspirin as indicated at follow up
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Miedema, MD
Organizational Affiliation
Minneapolis Heart Institute Foundation
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30711463
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.
Results Reference
derived
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diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)
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