Evaluation of a Patient Portal Intervention for Diabetes: A Pilot Randomized Controlled Trial

NCT03947333 | Completed Results

• 2 other identifiers: 1908255K23DK106511
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to conduct a two-arm, parallel-design, pragmatic randomized controlled trial of a patient portal intervention for diabetes, My Diabetes Care, to evaluate its effect on patient activation and secondary cognitive, behavioral, and clinical outcomes.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; Patient Activation; Patient Web Portals; Health Information Technology

Outcome Measures

Primary Outcomes (2)

• Change in Patient Activation at 6 Months

  The uni-dimensional, 13-item, Patient Activation Measure (PAM-13) is a valid measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care). Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree. PAM-13 item responses result in total raw scores ranging from 13 to 52, which we converted to the linear interval scale of patient activation scores, ranging from 0 (lowest activation) to 100 (highest activation). The PAM-13 has good psychometric properties including excellent internal consistency reliability (Cronbach's alpha of 0.87). The PAM-13 scores have been used to predict healthcare outcomes including medication adherence and emergency room utilization.

  Baseline to 6-month follow-up

• Change in Patient Activation at 3 Months

  The uni-dimensional, 13-item, Patient Activation Measure (PAM-13) is a valid measure of patient activation (i.e., the knowledge, skills and confidence a person has in managing their own health and health care). Each item uses a 4-point Likert-type scale of response options ranging from strongly disagree to strongly agree. PAM-13 item responses result in total raw scores ranging from 13 to 52, which we converted to the linear interval scale of patient activation scores, ranging from 0 (lowest activation) to 100 (highest activation). The PAM-13 has good psychometric properties including excellent internal consistency reliability (Cronbach's alpha of 0.87). The PAM-13 scores have been used to predict healthcare outcomes including medication adherence and emergency room utilization.

  Baseline to 3-month follow-up

Secondary Outcomes (17)

• Change in Diabetes Self-Efficacy

  Baseline, 3-month follow up, 6-month follow-up

• Change in Diabetes Knowledge

  Baseline, 3-month follow up, 6-month follow-up

• Change in Diabetes Self-Care (General Diet Adherence)

  Baseline, 3-month follow up, 6-month follow-up

• Change in Diabetes Self-Care (Specific Diet)

  Baseline, 3-month follow up, 6-month follow-up

• Change in Diabetes Self-Care (Exercise Adherence)

  Baseline, 3-month follow up, 6-month follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the My Diabetes Care.

Other: My Diabetes Care

Control

NO INTERVENTION

Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the My Diabetes Care (i.e., usual care).

Interventions

My Diabetes Care OTHER

The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability.

Also known as: Patient-facing Diabetes Dashboard

Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes Mellitus
• Currently being treated with at least one antihyperglycemic medication
• Able to speak and read in English
• Reliable access to a computer (desktop or laptop) with internet capabilities
• Active VUMC patient web portal (known as My Health At Vanderbilt) account

You may not qualify if:

• Residing in a long term care facility
• Medical condition that affects my memory or ability to think.
• Severe visual impairment
• Currently participating in another diabetes-related research study

Sponsors & Collaborators

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

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• Martinez W, Hackstadt AJ, Hickson GB, Rosenbloom ST, Elasy TA. Evaluation of the My Diabetes Care Patient Portal Intervention: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2021 May 25;10(5):e25955. doi: 10.2196/25955.

  PMID: 34032578 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Patient Participation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: William Martinez, MD
• Organization: Vanderbilt University Medical Center

william.martinez@vumc.org

(615) 936-1010

Study Officials

• William Martinez, MD, MS

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 13, 2019
• Study Start: March 9, 2020
• Primary Completion: January 11, 2021
• Study Completion: January 11, 2021
• Last Updated: March 31, 2022
• Results First Posted: March 31, 2022

Record last verified: 2022-03

Locations

US (1)