Treatment Burden Screening Questionnaire Pilot Study

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT05870202
• Lead Sponsor: University of Minnesota

Brief 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.

Study Timeline

• Study Start: 2023-03-07
• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-23
• Primary Completion: 2024-05-15
• Status Verified: 2025-04
• Study Completion: 2025-04-01
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 18 years of age or older, a diagnosis of T2DM, receiving primary care in a participating clinic, and having an in-person clinic visit with a participating trained clinician.

Exclusion Criteria

• Cognitive impairment, residing in a nursing home, and pregnancy (to avoid recruiting patients with gestational diabetes).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acceptability	Baseline to 6 month follow up	Helpfulness and utility of the intervention screening tool as assessed by 1) patient post intervention surveys and clinician post intervention surveys to identify patterns of patient and clinician participants' impressions of the helpfulness and utility of the intervention, and 2) acceptability of the intervention using qualitative interviews.
Feasibility of the clinical trial	Baseline to 6 month follow up	Patients' willingness to participate in the study as assessed by: 1) percentage of approached and eligible patients who consent to enroll in the study, 2) percentage of participants who completed the study procedures including baseline survey data collection, 3) use of the screening tool and completion of the post-intervention visit survey 4) time (days) to recruit 50 subjects across 2 clinic sites.

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c	Baseline and 6 month follow up	Change in HbA1c from baseline to 6 months

Trial Locations

Locations (2)

Community University Health Center; 🇺🇸 Minneapolis, Minnesota, United States

Hennepin Health Care - Whittier Clinic; 🇺🇸 Minneapolis, Minnesota, United States