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OpenTrials
Completed

NCT Number: NCT05870202

Treatment Burden Screening Questionnaire Pilot Study

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Community University Health Center, Minneapolis, Minnesota, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

screening tool

Other

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.

Primary outcomes

  1. Feasibility of the clinical trial

    Time frame: Baseline to 6 month follow up

    Patients' willingness to participate in the study as assessed by:

    • 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.

  2. Acceptability

    Time frame: 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.

Secondary outcomes

  1. Change in HbA1c

    Time frame: Baseline and 6 month follow up

    Change in HbA1c from baseline to 6 months

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Hennepin Health Care

Registry information

Official study title

Optimizing Diabetes Care Quality for Low-Income Patients

Acronym: TBQ

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 23, 2023
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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