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

Use of a Smart-phone Based Medication Adherence Platform to Improve Outcomes in Uncontrolled Non-insulin Dependent Diabetes Among Veterans: a Pragmatic, Point-of-care, Implementation Effectiveness Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Diabete Type 2
• Intervention / Treatment: Behavioral: Dayamed Arthur a novel intelligent medication adherence platform

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89502
      • VA Sierra Nevada Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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.	Behavioral: Dayamed Arthur a novel intelligent medication adherence platform; Novel smart phone adherence application configured with subject pharmacy data providing accurate reminders of when to take medications and providing auditable user feed back to clinical care teams for patient response directed provider intervention.
No Intervention: Standard of Care Arm; Study subjects will be counseled on medication adherence and strategies to remember how to take their medications correctly. Study subjects will then be followed as clinically indicated by their clinical care team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from pre-intervention baseline in hemoblobin A1c	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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Medication Adherence Score from baseline	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	3 months

Collaborators and Investigators

• Sponsor: VA Sierra Nevada Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 1655381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No