The Diabetes Medication Adherence Promotion Intervention Trial

NCT02458495 | Completed DMC

• 1 other identifier: K01DK087894
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

A significant percentage of persons with diabetes fail to properly take their prescribed oral hypoglycemic agents (OHA) and insulin. Non-adherence to medications among diabetes patients is associated with poor health outcomes including suboptimal glycemic control, diabetes-related complications, elevated health costs and increased risk of hospitalization and mortality. Given the substantial impact of non-compliance on the health of patients, prior studies have sought to draw links between medication adherence and patient factors. Research shows that web-based interventions that support patients' medication-related knowledge, motivation and skills effectively improve compliance. The purpose of this study is to evaluate the impact of a patient web portal (PWP)-delivered medication adherence promotion intervention on medication adherence and glycemic control among patients with type 2 diabetes (T2DM). The intervention aims to (1) increase self-reported adherence to glucose lowering agents (GLAs) and (2) improve diabetes health outcomes (decreased HbA1c) by increasing patients' medication adherence-related knowledge, motivation and skills. This research will greatly enhance the investigators' understanding of medicine compliance and the factors that effectively improve adherence among high-risk patients with diabetes. Knowledge gained from this work may inform future internet-based patient portals that support disease management and medication adherence more broadly.

Conditions

Diabetes Mellitus, Type 2

Keywords

Internet; Mobile Health; Hemoglobin A, Glycosylated; Medication Adherence; Psychological Theory

Outcome Measures

Primary Outcomes (1)

• Glycemic control (Change in participant's HbA1c level)

  Change in participant's HbA1c level from study onset to study conslusion

  Change from Baseline in HbA1c level at 3 months

Secondary Outcomes (4)

• Number of logins, 1 month assessment

  1 month after Baseline

• Number of logins, 3 month assessment

  3 months after Baseline

• Time spent on website, 1 month assessment

  1 month after Baseline

• Time spent on website, 3 month assessment

  3 months after Baseline

Study Arms (2)

Standard of Care Control Group

NO INTERVENTION

Participants will be granted access to a generic Diabetes website. Participants will complete the same eligibility and baseline self-report as the intervention group. The 1 month and 3 month self-report survey will omit mention of the Diabetes MAP website and will reference the generic diabetes website. Participants will be provided with access to a generic Diabetes website. Participants will complete the same eligibility, baseline and self-report surveys as the intervention group.

Diabetes MAP Intervention Group

EXPERIMENTAL

Participants will be granted access to the Diabetes MAP website. Participants will complete the same eligibility and baseline self-report as the control group. The 1 month and 3 month self-report will refer to the Diabetes MAP website specifically.

Behavioral: Diabetes MAP Intervention

Interventions

Diabetes MAP Intervention BEHAVIORAL

Diabetes MAP Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years and older (to be confirmed by electronic health record)
• Individuals who have received a diagnosis for type 2 diabetes mellitus (T2DM)
• Enrolled as a patient in the Vanderbilt APPC or the Eskind Diabetes Clinic
• Registered My Health at Vanderbilt user
• Recent A1c of 7.0 or greater
• Individuals currently being treated with oral and/or injectable diabetes medication (to be confirmed through electronic health record)

You may not qualify if:

• Non-English speakers (determined by a trained research assistant)
• Individuals with a severe hearing or visual impairment (determined subjectively by a trained research assistant)
• Individuals with delirium or a severe cognitive impairment (determined by a lack of orientation to person, place, and time)
• Individuals who report a caregiver administers their diabetes medications
• Individuals who report they do not have a mobile phone or computer with internet access
• Individuals unwilling and/or unable to provide written informed consent

Sponsors & Collaborators

• Vanderbilt University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Medication Adherence

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Chandra Y Osborn, PhD, MPH

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine & Biomedical Informatics, Co-Director for CHBHE

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: June 1, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

US (1)