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Completed

NCT Number: NCT05789706

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Sierra Nevada Health Care System

Reno, Nevada, 89502, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change from pre-intervention baseline in hemoblobin A1c

    Time frame: 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 outcomes

  1. Change in Medication Adherence Score from baseline

    Time frame: 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

Sponsors and collaborators

Lead sponsor

VA Sierra Nevada Health Care System

Fed

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2023
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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