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Pilot and Feasibility Trials on the Integration of Social and Medical Care for Type 1 Diabetes Mellitus (R01 Clinical Trial Required)

1. Applicant Information: Name, contact information, and institutional affiliation of the primary applicant.

2. Project Title: A concise and descriptive title for the proposed pilot and feasibility trial.

3. Project Summary: A brief summary of the proposed research, including the main objectives, methods, and expected outcomes.

4. Background and Significance: A description of the need for integrating social and medical care for individuals living with type 1 diabetes, highlighting the health disparities that exist and the potential impact of addressing social determinants of health.

5. Specific Aims: Clear and defined objectives for the pilot and feasibility trial, including the feasibility of screening for social risks, implementing referral service linkages, and assessing the impact on both social risk factors and type 1 diabetes outcomes.

6. Methods: Detailed information on the study design, participant recruitment and selection criteria, screening processes, intervention protocols, data collection methods, and analysis plan.

7. Budget and Budget Justification: A comprehensive budget that outlines the anticipated costs for personnel, equipment, supplies, participant incentives, data management, and other necessary expenses. The budget justification should provide a rationale for each budget item.

8. Timeline: A project timeline indicating the start and end dates of each phase of the pilot and feasibility trial, including participant recruitment, intervention implementation, data collection, analysis, and dissemination of findings.

9. Research Team: Information on the key personnel involved in the proposed study, including their qualifications, roles, and responsibilities.

10. Collaboration Plan: A description of how collaborations will be established and maintained between healthcare systems, community-based organizations, and social service entities to ensure the successful implementation of the interventions.

11. Institutional Support: Documentation of institutional support, including letters of support or commitment from relevant departments or institutions.

12. Human Subjects Protection: An explanation of how the study will comply with ethical guidelines and ensure the protection of human subjects, including obtaining informed consent, ensuring privacy and confidentiality, and addressing any potential risks or benefits.

13. Data Sharing Plan: A statement on how the data collected during the pilot and feasibility trial will be managed, stored, and shared, including any plans for data sharing with other researchers or institutions.

14. References: A list of relevant references cited in the grant application.

15. Appendices: Any additional supporting documents, such as CVs, letters of collaboration, survey instruments, or informed consent forms.

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88%

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93%

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