Treatment Burden Screening Questionnaire Pilot Study

NCT05870202 | Completed

• 1 other identifier: GIM-2024-33207
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; treatment burden

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Change in HbA1c

  Baseline and 6 month follow up

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with type 2 diabetes receiving care in a safety-net primary care clinic.

You may qualify if:

• 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.

You may not qualify if:

• Cognitive impairment, residing in a nursing home, and pregnancy (to avoid recruiting patients with gestational diabetes).

Sponsors & Collaborators

• University of Minnesota: lead
• Hennepin Health Care: collaborator

Study Sites (2)

Community University Health Center

Minneapolis, Minnesota, 55404, United States

Location

Hennepin Health Care - Whittier Clinic

Minneapolis, Minnesota, 55408, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Potentially Inappropriate Medication List

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 23, 2023
• Study Start: March 7, 2023
• Primary Completion: May 15, 2024
• Study Completion: April 1, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)