Use of a Smart-phone Based Medication Adherence Platform to Improve Outcomes in Uncontrolled Non-insulin Dependent Diabetes Among Veterans

Not Applicable

Completed

• Conditions: Diabetes; Diabete Type 2
• Interventions: Behavioral: Dayamed Arthur a novel intelligent medication adherence platform

• Registration Number: NCT05789706
• Lead Sponsor: VA Sierra Nevada Health Care System

Brief Summary

The purpose of this study is to determine if a novel smartphone-based medication adherence platform accompanied by directed pharmacist intervention can improve A1c control and medication compliance in non-insulin dependent diabetics.

Detailed Description

This study will employ a case-crossover design where patients will undergo both a standard of care arm as well as an intervention arm (See Figure 1). Half of the study participants will be randomized and enrolled in the standard of care arm for the initial 3 months and then transition to the intervention arm for 3 months. The remaining patients will be enrolled in the intervention arm for the initial 3 months and then transitioned to the standard of care arm.

Primary outcomes will be the change from pre-intervention baseline in hemoblobin A1c (HgA1c) between the Dayamed Arthur platform and standard of care.

Secondary outcomes will include change in MAS, the change in RMA from week 1 of intervention arm to week 12, comparison of historical MPR and PDC with patient's RMA at week 1 of intervention arm, and correlation of change in RMA and MAS score during intervention arm. Furthermore, we will measure sustained change in MAS in the patient population who begin study in the intervention arm and are subsequently transitioned to standard of care. We will also collect information patient usability/acceptability and provider satisfaction with the Dayamed Arthur platform.

Exploratory outcomes will include potential reduction in healthcare resource utilization based on avoidance of therapy escalation in patients with improved compliance, as well as psychosocial factors associated with improved adherence

Reduction of HgbA1c by 0.5% from pre-intervention baseline for individuals on the DayaMed intervention compared to standard of care

Study Timeline

• Study Start: 2021-03-24
• Study First Submitted: 2022-10-24
• Primary Completion: 2023-01-01
• Status Verified: 2023-03
• Study Completion: 2023-03-01
• Study First Submitted QC: 2023-03-15
• Last Update Submitted: 2023-03-15
• Study First Posted: 2023-03-29
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Assigned primary care provider at VA Sierra Nevada Healthcare System (VASNHCS)

• Diagnosis of type 2 diabetes

• Own a smart phone/tablet

• HgbA1c drawn at or within 30 days of study enrollment.

• Uncontrolled A1c defined as an A1c >9 in the following order of preference

  • Last 3 A1cs >9% in the last 2 year
  • Last 2 A1cs >9% in the last 2 years
  • Last A1c >9% in the last 2 years
  • 2-year average A1c >9%

Exclusion Criteria

• Actively on insulin therapy
• Unable to install DayaMed application onto their phone/tablet
• Unable to load medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Dayamed Arthur a novel intelligent medication adherence platform	Patients will have Dayamed Arthur a novel intelligent medication adherence platform installed on their smartphone and configured with their pharmacy data providing accurate prompts and reminders to patients to take medications as directed In addition to the prompts patient all auditable information will be relayed to their PACT CPS through a provider dashboard allowing for timely and directed clinical intervention. Dayamed Arthur will provide automated alerts to the patients care team in specific scenarios.

Primary Outcome Measures

Name	Time	Method
Change from pre-intervention baseline in hemoblobin A1c	3 months	The change from pre-intervention baseline in hemoblobin A1c (HgA1c) to 3 months in the intervention arm compared to change from baseline to 3 months in the standard of care arm

Secondary Outcome Measures

Name	Time	Method
Change in Medication Adherence Score from baseline	3 months	change from baseline to 3 months in medication adherence score in the intervention arm compared to change from baseline to 3 months in medication adherence score in the standard of care arm

Trial Locations

Locations (1)

VA Sierra Nevada Health Care System; 🇺🇸 Reno, Nevada, United States