Effect of Remote Patient Monitoring and Patient Education on Patient Activation and Glycemic Control in Individuals With Type 2 Diabetes

February 15, 2023 updated by: Tracy Jalbuena MD
This is a randomized controlled trial of the use of Remote Patient Monitoring (RPM) compared to usual care among rural patients with poorly controlled type 2 diabetes. Usual care is defined as participation in Living Well with Diabetes/Virtual Diabetes Self-Management Program and Primary Care Provider evaluation and management at the providers' discretion, including medication adjustment or interventions, and other types of interventions depending on clinical judgement.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Effect of Remote Patient Monitoring and Patient Education on Patient Activation and Glycemic Control in Individuals with Type 2 Diabetes

Summary

ABSTRACT

In 2021, the MaineHealth Telehealth team was awarded a five-year, $1.7 million "Evidence-Based Telehealth Network Program" grant (EB TNPG) from Health Resources and Services Administration (HRSA). This grant is aimed at improving patient access to educational and management services for patients with type 2 diabetes in the rural Maine primary care setting by implementing RPM. The RPM devices will be used to transmit a participant's home point-of-care blood glucose values directly into MaineHealth's electronic medical record in real time. While there is strong evidence for diabetes self-management programs such as Living Well with Diabetes, the importance of patient engagement in clinical outcomes, the validity of the Patient Activation Measure (PAM-13®) survey to measure patient activation, and the overall efficacy of remote patient monitoring, there have been no randomized controlled trials looking at patient activation in remote patient monitoring in this important patient group. The investigators aim to address this in this study by conducting a randomized controlled trial of the use of RPM among rural patients with poorly controlled type 2 diabetes. The control group will have usual primary care provider care, including patient self-management tools, while the intervention group will have usual care + RPM.

The investigators hypothesize that participation in RPM will be associated with decreases in HbA1c, increases in patient activation as measured by PAM-13® survey, and that increases in patient activation will be associated with decreases in HbA1c.

STUDY PROCESS

The study will be conducted over 5 years, and participants will be enrolled on a continuous rolling basis, with 70 total RPM kits available at any one time from a 3rd party vendor, Health Recovery Solutions (HRS). The maximum total number of participants the study can accommodate is 700, with 350 participants in each arm. The study team hopes for total enrollment as close to 700 as possible, but understands that total enrollment may be significantly less than 700. Point-of-care blood glucose values from the RPM study arm will flow into MaineHealth's electronic medical record (Epic) in real time. Every other week, the values will be reviewed by a clinical pharmacist with expertise in diabetes management. If an intervention or adjustment in the patient's regimen is indicated, the pharmacist will reach out to the Primary Care Provider (PCP) team to make this recommendation. The RPM intervention for each participant will be 6 months, at which point HRS will collect the RPM electronic tablet, and the PAM-13® survey will be administered. At 9 months after enrollment, the third HbA1c value will be collected from the electronic medical record, and the third administration of PAM-13® will take place.

The PAM-13® survey will be administered through one of two methods 1) REDCap electronic form, the link for which will be sent to the participant by email, or 2) by telephone, administered by the Study Coordinator.

Recruitment of participants will continue through the early part of 2026. Data will be analyzed during spring and summer of 2026, and the grant's end date is August 31, 2026.

This study has been approved by MaineHealth's IRB as of Aug 5, 2022.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maine
      • Rockport, Maine, United States, 04856
        • PenBay Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be enrolled in Living Well with Diabetes education program
  • Have an HbA1c% ≥ 8 in the prior 6 months
  • Be capable of providing consent
  • Be adults (age 18 or over)

Exclusion Criteria:

  • Primarily managed by endocrinology for their diabetes (> 1 visit with endocrinology in the previous 12 months)
  • Incarcerated
  • PCP not at one of the 30 primary care practices listed (see attachment List of PCP Practices)
  • Diagnosed with type 1 diabetes
  • Candidate for continuous glucose monitoring, as defined by Centers for Medicare and Medicaid Services as using at least three insulin injections per day, any combination of types of insulins
  • Pregnant
  • Have previously participated in the Living Well with Diabetes/Virtual Diabetes Self-Management Program
  • Have previously used a remote patient monitoring device for diabetes management
  • Have a diagnosis of dementia or other clinical diagnosis that would impair participation capacity
  • Currently participating in any other clinical trial regarding diabetes care or management
  • Currently enrolled in hospice
  • Currently residing in a long term care or rehabilitation facility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Living Well with Diabetes
Usual care is defined as participation in Living Well with Diabetes/Virtual Diabetes Self-Management Program, PCP evaluation and management, including medication adjustment or interventions, and other types of interventions depending on clinical judgement. This may include eConsults between the provider and a pharmacist, in-person visits between the provider and the patient, synchronous telemedicine visits between the provider and the patient, and synchronous telemedicine visits between the pharmacist and the patient.
Experimental: Living Well with Diabetes + Remote Patient Monitoring
Remote patient monitoring as the intervention is defined as a tablet and Bluetooth-enabled glucometer technology that collects point-of-care (POC) blood glucose data from a patient outside of a traditional clinical setting, and securely transmits this data to Epic for review and potential intervention.
Device: Remote Patient Monitoring
Remote patient monitoring as the intervention is defined as a tablet and Bluetooth-enabled glucometer technology that collects point-of-care (POC) blood glucose data from a patient outside of a traditional clinical setting, and securely transmits this data to Epic for review and potential intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean HbA1c%
Time Frame: 6 months after enrollment
Average glycated hemoglobin
6 months after enrollment
Mean HbA1c%
Time Frame: 9 months after enrollment
Average glycated hemoglobin
9 months after enrollment
Mean change in HbA1c%
Time Frame: 6 months after enrollment
Average change in percentage of HbA1c from baseline to 6 months after enrollment
6 months after enrollment
Mean change in HbA1c%
Time Frame: 9 months after enrollment
Average change in percentage of HbA1c from baseline to 9 months after enrollment
9 months after enrollment
Percentage of participants in each group who have HbA1c < 7%
Time Frame: 6 months after enrollment
Percentage of participants in each group with HbA1c < 7%
6 months after enrollment
Percentage of participants in each group who have HbA1c < 7%
Time Frame: 9 months after enrollment
Percentage of participants in each group with HbA1c < 7%
9 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PAM-13 at 6 months after enrollment
Time Frame: 6 months after enrollment

PAM-13 Patient Activation Measure Survey

Unabbreviated scale title: Patient Activation Measure 13-Item Survey Minimum value: 0 Maximum value: 100 Higher values are associated with better health outcomes
6 months after enrollment
PAM-13 at 9 months after enrollment
Time Frame: 9 months after enrollment

PAM-13 Patient Activation Measure Survey

PAM-13 Patient Activation Measure Survey

Unabbreviated scale title: Patient Activation Measure 13-Item Survey Minimum value: 0 Maximum value: 100 Higher values are associated with better health outcomes
9 months after enrollment
Mean change in PAM-13 at 6 months
Time Frame: 6 months after enrollment

Average change in PAM-13 Patient Activation Measure Survey score from baseline to 6 months after enrollment

Unabbreviated scale title: Patient Activation Measure 13-Item Survey Minimum value: 0 Maximum value: 100 Higher values are associated with better health outcomes
6 months after enrollment
Mean change in PAM-13 at 9 months
Time Frame: 9 months after enrollment

Average change in PAM-13 Patient Activation Measure Survey score from baseline to 9 months after enrollment

Unabbreviated scale title: Patient Activation Measure 13-Item Survey Minimum value: 0 Maximum value: 100 Higher values are associated with better health outcomes
9 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tracy Jalbuena MD

Collaborators

Health Resources and Services Administration (HRSA)
MaineHealth

Investigators

  • Principal Investigator: Tracy Jalbuena, MD, MaineHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2022

Primary Completion (Anticipated)

June 30, 2026

Study Completion (Anticipated)

August 31, 2026

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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