Treatment Burden Screening Questionnaire Pilot Study

Type 2 Diabetes Clinical Trial

— TBQ  

Official title:

Optimizing Diabetes Care Quality for Low-Income Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05870202
• Other study ID #: K23DK118207
• Status: Active, not recruiting
• Start date: March 7, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: May 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: December 15, 2024
• Est. primary completion date: May 15, 2024
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Community University Health Center	Minneapolis	Minnesota
United States	Hennepin Health Care - Whittier Clinic	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	Hennepin Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the clinical trial	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.	Baseline to 6 month follow up
Primary	Acceptability	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.	Baseline to 6 month follow up
Secondary	Change in HbA1c	Change in HbA1c from baseline to 6 months	Baseline and 6 month follow up