Treatment Burden Screening Questionnaire Pilot Study (TBQ)

University of Minnesota (UMN)

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Other: screening tool

Study type: Observational

Funder types: Other

Identifiers

NCT05870202

GIM-2024-33207

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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).