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

Sponsor
Tracy Jalbuena MD (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05541120
Collaborator
MaineHealth (Other), Health Resources and Services Administration (HRSA) (U.S. Fed)
700
Enrollment
2
Arms
47.6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Remote Patient Monitoring
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
700 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is a randomized controlled trial of the use of RPM compared to usual care among MaineHealth's rural patients with poorly controlled diabetes, where the participant's diabetes is managed primarily by primary care (as opposed to endocrinology). Usual care is defined as participation in Living Well with Diabetes/Virtual Diabetes Self-Management Program, PCP evaluation and management at the providers' discretion, 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.This study is a randomized controlled trial of the use of RPM compared to usual care among MaineHealth's rural patients with poorly controlled diabetes, where the participant's diabetes is managed primarily by primary care (as opposed to endocrinology). Usual care is defined as participation in Living Well with Diabetes/Virtual Diabetes Self-Management Program, PCP evaluation and management at the providers' discretion, 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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Remote Patient Monitoring and Patient Education on Patient Activation and Glycemic Control in Individuals With Type 2 Diabetes
Anticipated Study Start Date :
Sep 13, 2022
Anticipated Primary Completion Date :
Jun 30, 2026
Anticipated Study Completion Date :
Aug 31, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Mean HbA1c% [6 months after enrollment]

    Average glycated hemoglobin

  2. Mean HbA1c% [9 months after enrollment]

    Average glycated hemoglobin

  3. Mean change in HbA1c% [6 months after enrollment]

    Average change in percentage of HbA1c from baseline to 6 months after enrollment

  4. Mean change in HbA1c% [9 months after enrollment]

    Average change in percentage of HbA1c from baseline to 9 months after enrollment

  5. Percentage of participants in each group who have HbA1c < 7% [6 months after enrollment]

    Percentage of participants in each group with HbA1c < 7%

  6. Percentage of participants in each group who have HbA1c < 7% [9 months after enrollment]

    Percentage of participants in each group with HbA1c < 7%

Secondary Outcome Measures

  1. PAM-13 at 6 months after enrollment [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

  2. PAM-13 at 9 months after enrollment [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

  3. Mean change in PAM-13 at 6 months [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

  4. Mean change in PAM-13 at 9 months [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tracy Jalbuena MD
  • MaineHealth
  • Health Resources and Services Administration (HRSA)

Investigators

  • Principal Investigator: Tracy Jalbuena, MD, MaineHealth

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Tracy Jalbuena MD, Clinical Lead for Telehealth, MaineHealth
ClinicalTrials.gov Identifier:
NCT05541120
Other Study ID Numbers:
  • 00000
First Posted:
Sep 15, 2022
Last Update Posted:
Sep 15, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tracy Jalbuena MD, Clinical Lead for Telehealth, MaineHealth
remote patient monitoring
glycemic control
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 15, 2022