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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05789706
• Other study ID #: 1655381
• Status: Completed
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: VA Sierra Nevada Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
United States	VA Sierra Nevada Health Care System	Reno	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
VA Sierra Nevada Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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