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Clinical Trials/NCT05870202
NCT05870202
Completed
Not Applicable

Optimizing Diabetes Care Quality for Low-Income Patients

University of Minnesota2 sites in 1 country64 target enrollmentMarch 7, 2023
ConditionsType 2 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
University of Minnesota
Enrollment
64
Locations
2
Primary Endpoint
Acceptability
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 7, 2023
End Date
April 1, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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.

Feasibility of the clinical trial

Time Frame: 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 Outcomes

  • Change in HbA1c(Baseline and 6 month follow up)

Study Sites (2)

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