Primary Care Diabetes Feasibility Pilot

A single-arm feasibility study of a patient-facing smartphone application for adults with type 2 diabetes

Study at a glance

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‍Rationale

MAVEN Health is a smartphone app designed to help people manage four common chronic conditions in primary care: diabetes, depression, low back pain, and chronic obstructive pulmonary disease.

MAVEN Health's dual design — patient activation paired with a "clinical-translation" summary that carries what the patient knows into the visit — is novel and untested as a whole. Component-level evidence exists for the parts; the integrated approach does not yet have evidence behind it. Diabetes is the first of MAVEN Health's four conditions to be studied.

Aims

This pilot tests the feasibility of that integrated approach in routine primary care before a definitive efficacy trial. The pilot aims to:

1. Assess the sustained engagement with MAVEN.
2. Assess the feasibility of recruitment and retention across two primary-care sites.
3. Evaluate the acceptability, usability, and clinical integration of MAVEN among patients and PCPs.
4. Assess the feasibility of complete and timely capture of EHR and patient-reported outcome data.

This pilot is not designed to test efficacy.

Eligibility criteria

Inclusion— Adults ≥18 · type 2 diabetes ≥6 months · latest HbA1c ≥8.0% · smartphone · English-speaking.

Exclusion— Type 1 diabetes · pregnancy · dialysis · impairment preventing app use · participation in another diabetes program or app.

Approach

Potentially eligible patients are identified through the EHR, invited through secure messaging/email, screened and consented electronically in REDCap, and then complete baseline measures and MAVEN onboarding. Enrollment is rolling across both sites to a target of 80 participants, yielding 60 analyzable participants after an anticipated 25% attrition. Recruitment, eligibility, enrollment, and retention are tracked throughout.

Timeline

Measures

Primary outcome:

- Sustained engagement (≥2 qualifying MAVEN sessions/week in ≥8 of 12 weeks.)

Secondary outcomes:

- Recruitment and retention

- Use of the clinician summary

- Patient and PCP acceptability and usability

- Completeness of EHR and patient-reported outcome data

Patient reported outcomes are collected at baseline, 6 weeks and 12 wekks.

Team

Coordinating center: QuEST Center at Bursky School of Public Health, WashU

Clinical sites : ‍

- BJC Healthcare / WashU Medicine (urban)

- University of Missouri Health Care / Family & Community Medicine (rural). 

Advisory: Center for Diabetes Translation Research (CDTR), WashU

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