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

NCT05789706 | Completed

• 1 other identifier: 1655381
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabete Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Medication Adherence Score from baseline

  3 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Standard of Care Arm

NO INTERVENTION

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.

Interventions

Dayamed Arthur a novel intelligent medication adherence platform BEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• year average A1c \>9%

You may not qualify if:

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

Sponsors & Collaborators

• VA Sierra Nevada Health Care System: lead

Study Sites (1)

VA Sierra Nevada Health Care System

Reno, Nevada, 89502, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief of Pharmacy - Health Outcomes and Analytics

Model Details: This study will employ a case-crossover design where patients will undergo both a standard of care arm as well as an intervention arm. 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.

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: March 29, 2023
• Study Start: March 24, 2021
• Primary Completion: January 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)