STUDIIO-Diabetes Pilot: STUdy of Drug Insurance to Improve Outcomes of Diabetes

NCT03804905 | Not Yet Recruiting

• 1 other identifier: 103-2018
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

Canada is the only country with a universal health insurance system that does not provide coverage for prescription drugs to all residents. One-third of working-age Canadians have no insurance. Importantly, many of these uninsured patients already face other barriers to good health: low income, new immigrants, single mothers, etc. For these patients, taking prescription drugs - especially chronic disease treatments that may be required lifelong - can be difficult due to high costs. Patients skip doses, delay renewing prescriptions, or simply do not fill prescriptions recommended by their doctors, because they do not have insurance to cover the costs of prescriptions. Previous research by the study team has suggested that the lack of a universal drug insurance program for working-age Canadians affects the health and well-being of low-income people with diabetes. The goal of this research is to determine the clinical and economic impact of providing drug coverage for uninsured type 2 diabetics.

Conditions

Type 2 Diabetes Mellitus; Medication Adherence; Medication Compliance; Medication Nonadherence

Keywords

Type 2 Diabetes Mellitus; Medication Compliance; Medication Insurance

Outcome Measures

Primary Outcomes (1)

• Lacking medication insurance

  Proportion of type 2 diabetes patients aged 25 to 64 who self-report that they lack medication insurance

  During 2 month run-in period

Secondary Outcomes (4)

• Online questionnaire during the run-in period

  During 2 month run-in period

• Response to the insurance status question

  During 2 month run-in period

• Recipient of no-cost medications

  One year

• Time from allocation to use of Trillium Health Partners outpatient pharmacy

  One year

Other Outcomes (10)

• All-cause mortality or cardiovascular complications

  One year

• Other chronic diabetes complications

  One year

• Acute diabetes complications

  One year

Study Arms (2)

No-cost Medications

EXPERIMENTAL

Eligible patients of physicians allocated to the no-cost medications arm will receive free medications through Trillium Health Partners outpatient pharmacy.

Other: No-cost Medications

Usual care

NO INTERVENTION

Eligible patients of physicians allocated to the usual care arm will continue to access their medications through self-pay or other mechanisms.

Interventions

No-cost Medications OTHER

Patients will be connected to Trillium Health Partners outpatient pharmacy, and they will be given an information sheet with further details. The patients will get free access to diabetes, blood pressure and cholesterol medications and for glucose test strips. They can attend the pharmacy in person or arrange for home delivery.

No-cost Medications

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• clinical diagnosis of type 2 diabetes record in family physician's electronic medical record
• lack of medication insurance

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Medication Adherence

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Baiju Shah, MD PhD FRCPC

CONTACT

416-997-4706; baiju.shah@ices.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 15, 2019
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-12