Type 2 Diabetes (T2D) Clinical Trials

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Community Pharmacist Prescription for Diabetic Kidney Disease (Rx4DKD): A Randomized Controlled Trial and Implementation Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Type 2 diabetes is the leading cause of chronic kidney disease, which can result in serious complications such as kidney failure and heart disease. Although effective medications exist to slow the progression of kidney damage, they are often underused in primary care, particularly for individuals without a regular family doctor. In response to this gap, 46 community pharmacy-led primary care clinics were launched across Nova Scotia in 2023 to serve under-resourced areas. Pharmacists at these clinics can prescribe for many chronic conditions, but currently not for diabetic kidney disease. To address this, the research team collaborated with kidney, diabetes, and primary care experts, patient partners and regulatory bodies to develop and validate step-by-step prescribing guide (called algorithms) that support pharmacists in identifying and managing diabetic kidney disease. All medications included are approved, publicly funded in Nova Scotia, target people with earlier categories of diabetic kidney disease and includebuilt-in safety monitoring, nurse practitioner consultation or referral to a kidney doctor. This study will evaluate whether these algorithms improve kidney protective medication use which have shown to be beneficial for people with diabetes and kidney disease. The investigators will recruit 120 adults with type 2 diabetes from a provincial diabetes registry who do not have a primary care provider and screen them at pharmacy clinics for diabetic kidney disease. Those eligible and who wish to participate will be randomly assigned to either an intervention group receiving pharmacist-led care using the algorithms or a control group receiving usual care through walk-in, mobile, or virtual clinics. The investigators will measure how many patients begin and continue recommended medications, as well as any medication-related side effects or hospitalizations. Pharmacist participants will also complete a survey to identify what helps or hinders implementation in real-world practice. This research is relevant because it aims to expand access to kidney-protective treatments for people with diabetes, especially those with early forms of diabetic kidney disease who do not have regular access to primary care provider, ultimately improving long-term health outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults ≥18 years with T2D and DKD (eGFR≥ 30-60 ml/min/1.73m2 and/or UACR≥3 mg/mmol)

• Adults who do not have primary care provider,

• Adults who are eligible for initiation of treatment with RASi, SGLT2i or nsMRA

Locations
Other Locations
Canada
Dalhousie University
RECRUITING
Halifax
Contact Information
Primary
Jo-Anne Wilson, BSc Pharm, ACPR, MEd, PharmD
Jo-Anne.wilson@dal.ca
9024886623
Backup
Laura Sills, RN, BSN
Laura.Sillis@nshelath.ca
+1-(289)-201-4175
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 120
Treatments
Active_comparator: Arm 1 ( Intervention group)
Participants will receive ongoing clinical care from a community pharmacy primary care clinic, with pharmacists managing diabetic kidney disease using validated prescription algorithms.
Placebo_comparator: Arm 2 ( control group)
Participants will continue with usual care through, walk-in or mobile clinics for their diabetic kidney disease care.
Sponsors
Leads: Nova Scotia Health Authority

This content was sourced from clinicaltrials.gov