- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02980978
diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED) (ENHANCED)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Intervention
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
|
Ingen indgriben: Standard of Care
Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
A1c (Laboratory Assessment)
Tidsramme: 1 year
|
The count of participants represents the number of individuals meeting A1c less than 8% at follow up
|
1 year
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings)
Tidsramme: 1 year
|
The count of participants represents the number of individuals meeting blood pressure less than 140/90 at follow up
|
1 year
|
Tobacco Use (Self-reported Questionnaire)
Tidsramme: 1 year
|
The count of participants represents those not using tobacco at follow up
|
1 year
|
Statin Use (as Noted in EMR)
Tidsramme: 1 year
|
The count of participants represents those taking a statin as indicated at follow up
|
1 year
|
Aspirin Use (as Noted in EMR)
Tidsramme: 1 year
|
The count of participants represents taking aspirin as indicated at follow up
|
1 year
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ENHANCED
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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