An interventional study of Coaching in Diabetes Mellitus, Type 2, sponsored by Minneapolis Heart Institute Foundation. Completed. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-29.
Sponsored by Minneapolis Heart Institute Foundation · Not applicable, Interventional, and Supportive care
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.
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
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 118 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Minneapolis Heart Institute Foundation is the lead sponsor of 33 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Behavioral: Coaching
Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
Focus on nutrition, activity and appropriate medication use and adherence
A1c (Laboratory Assessment)
The count of participants represents the number of individuals meeting A1c less than 8% at follow up
Time frame: 1 year
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
Time frame: 1 year
Tobacco Use (Self-reported Questionnaire)
The count of participants represents those not using tobacco at follow up
Time frame: 1 year
Statin Use (as Noted in EMR)
The count of participants represents those taking a statin as indicated at follow up
Time frame: 1 year
Aspirin Use (as Noted in EMR)
The count of participants represents taking aspirin as indicated at follow up
Time frame: 1 year
| Milestone | Intervention | Standard of Care |
|---|---|---|
| Started | 60 | 58 |
| Completed | 54 | 50 |
| Not completed | 6 | 8 |
The count of participants represents the number of individuals meeting A1c less than 8% at follow up
| Participants | Intervention | Standard of Care |
|---|---|---|
| A1c (Laboratory Assessment) | 35 | 35 |
The count of participants represents the number of individuals meeting blood pressure less than 140/90 at follow up
| Participants | Intervention | Standard of Care |
|---|---|---|
| Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings) | 24 | 20 |
The count of participants represents those not using tobacco at follow up
| Participants | Intervention | Standard of Care |
|---|---|---|
| Tobacco Use (Self-reported Questionnaire) | 44 | 40 |
The count of participants represents those taking a statin as indicated at follow up
| Participants | Intervention | Standard of Care |
|---|---|---|
| Statin Use (as Noted in EMR) | 50 | 32 |
The count of participants represents taking aspirin as indicated at follow up
| Participants | Intervention | Standard of Care |
|---|---|---|
| Aspirin Use (as Noted in EMR) | 45 | 34 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Standard of Care | 0/58 (0%) | 0/58 (0%) | 0/58 (0%) |
| Age, Categorical(Participants) | Intervention | Standard of Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 48 | 50 | 98 |
| >=65 years | 12 | 8 | 20 |
| Age, Continuous(Years) | Intervention | Standard of Care | Total |
|---|---|---|---|
| Mean | 59.8 ± 10.2 | 60.0 ± 8.66 | 59.9 ± 9.43 |
| Sex: Female, Male(Participants) | Intervention | Standard of Care | Total |
|---|---|---|---|
| Female | 28 | 25 | 53 |
| Male | 32 | 33 | 65 |
| Race (NIH/OMB)(Participants) | Intervention | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 2 |
| White | 56 | 52 | 108 |
| More than one race | 0 | 3 | 3 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Region of Enrollment(participants) | Intervention | Standard of Care | Total |
|---|---|---|---|
| United States | 60 | 58 | 118 |
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Minneapolis Heart Institute Foundation