Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT06046560
A randomized remote, implementation trial in the Mass General Brigham network was performed on 200 patients with T2D at high CV or kidney risk. The study's primary objective was to create a remote diabetes management platform that improved the initiation and adherence to glucose-lowering medications with CV and kidney benefit and was evaluated by the primary outcome: increasing the proportion of patients with prescriptions for GDMT therapy by 6 months.
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Notify Me27 year–79 year
All sexes
Interventional
Phase 4
Boston, Massachusetts, 02115, United States
A randomized remote, implementation trial in the Mass General Brigham network performed on 200 patients with T2D at high CV or kidney risk. Patients eligible for, but not prescribed, SGLT2i or GLP-1 RA were randomly assigned to 1) simultaneous patient education and medication initiation "simultaneous" arm or 2) 2-months of education followed by medication initiation "education-first" arm. A multi-disciplinary team provided education and prescribed GDMT using a treatment algorithm. The study's primary objective was to create a remote diabetes management platform that improved the initiation and adherence to glucose-lowering medications with CV and kidney benefit and was evaluated by the primary outcome: increasing the proportion of patients with prescriptions for GDMT therapy by 6 months. Secondary objectives included the primary outcome by randomization arm, prescribed therapy by 2 months, and patients taking prescribed therapy.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.
For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy.
Time frame: Any time between 0-months (baseline) to 6-months following enrollment
Number of patients with prescriptions of SGLT2i or GLP1-RA at any time
Time frame: 2-months following enrollment
Number of patients with prescriptions of SGLT2i or GLP1 RA at 2-months
Time frame: At 6-months following enrollment
Number of patients with prescriptions of SGLT2i or GLP1-RA at 6-months
Time frame: From 0-months (baseline) to 6-months following enrollment
Change in Short-form Patient Activation Measure (PAM)
The score is measured on a 0.0 - 4.0 point scale and indicates participants' relationships with and understanding of their health care. A higher value represents a better outcome. This measure indicates the change in participants' scores from the point of enrollment (0-months) to program completion (6-months).
0.0 - 1.0 (Disengaged & Overwhelmed)
1.1 - 2.0 (Becoming Aware But Still Struggling)
2.1 - 3.0 (Taking Action & Gaining Control)
3.1 - 4.0 (Maintaining Behaviors & Pushing Further)
Time frame: From 0-months (baseline) to 6-months following enrollment
Change in body weight (kg)
Time frame: From 0-months (baseline) to 6-months following enrollment
Change in body weight (%)
Time frame: From 0-months (baseline) to 6-months following enrollment
Change in laboratory measured HbA1c
Brigham and Women's Hospital
Other
DRIVE Program: Diabetes Remote Intervention to improVe Use of Evidence-based Medications
Acronym: DRIVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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