NCT05870202

Treatment Burden Screening Questionnaire Pilot Study

Optimizing Diabetes Care Quality for Low-Income Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: —

Summary

The main objective of this study is to develop and evaluate a clinic-based pilot intervention to optimize patient-centered diabetes care for low income patients at risk for low quality diabetes care and poor outcomes.

Detailed description

Single arm trial of a brief screening tool to identify areas of treatment burden in patients with diabetes, which will then be used as a tool in a primary care clinician visit discussion. We will assess (primary outcome) the acceptability and feasibility of 1. recruitment and retention processes; 2. screening tool usability; and (secondary outcomes) 3. outcome assessments. Data will include systematic tracking of recruitment and retention efforts, baseline and follow-up participant data, post-visit surveys of clinicians and participants, and patient participant qualitative interviews.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
OTHER	screening tool	The screening tool identifies areas of treatment burden in patients with type 2 diabetes. The tool is in the form of a brief questionnaire that the patient completes prior to a clinical appointment. The patient's responses to the questionnaire are then included in the discussion with the patient's primary care clinician during the clinical visit.

Timeline

• Start date: 2023-03-07
• Primary completion: 2024-05-15
• Completion: 2025-04-01
• First posted: 2023-05-23
• Last updated: 2025-04-24

Locations

2 sites across 1 country: United States