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ClinicalTrials.gov Identifier: NCT05870202
Recruitment Status : Enrolling by invitation
First Posted : May 23, 2023
Last Update Posted : May 23, 2023
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota
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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.
Type 2 Diabetes
Other: screening tool
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.
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Study Type :
Observational
Estimated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Optimizing Diabetes Care Quality for Low-Income Patients
Actual Study Start Date :
March 7, 2023
Estimated Primary Completion Date :
August 31, 2023
Estimated Study Completion Date :
February 28, 2024
Resource links provided by the National Library of Medicine
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Intervention Details:
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.
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Primary Outcome Measures :
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.
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 Outcome Measures :
Change in HbA1c [ Time Frame: Baseline and 6 month follow up ]
Change in HbA1c from baseline to 6 months
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Information from the National Library of Medicine
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Ages Eligible for Study: Â
18 Years to 95 Years  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Sampling Method: Â
Non-Probability Sample
Adult patients with type 2 diabetes receiving care in a safety-net primary care clinic.
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 NOW** patients with gestational diabetes).
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05870202
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Community University Health Center
Minneapolis, Minnesota, United States, 55404
Hennepin Health Care – Whittier Clinic
Minneapolis, Minnesota, United States, 55408
University of Minnesota
Hennepin Health Care
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Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT05870202 Â Â
Other Study ID Numbers:
K23DK118207 ( U.S. NIH Grant/Contract )
First Posted:
May 23, 2023 Â Â Key Record Dates
Last Update Posted:
May 23, 2023
Last Verified:
May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Minnesota:
type 2 diabetestreatment burden
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
