Clinical trial NCT05541120: Effect of Remote Patient Monitoring and Patient Education on Patient Activation and Glycemic Control in Individuals With Type 2 Diabetes
Official title: Effect of Remote Patient Monitoring and Patient Education on Patient Activation and Glycemic Control in Individuals With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: remote patient monitoring
glycemic control
Lead sponsor: MaineHealth
Sponsor class: OTHER
Collaborators: name: MaineHealth
name: Health Resources and Services Administration (HRSA)
First posted: 2022-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean HbA1c%
timeFrame: 6 months after enrollment
measure: Mean HbA1c%
timeFrame: 9 months after enrollment
measure: Mean change in HbA1c%
timeFrame: 6 months after enrollment
measure: Mean change in HbA1c%
timeFrame: 9 months after enrollment
measure: Percentage of participants in each group who have HbA1c < 7%
timeFrame: 6 months after enrollment
measure: Percentage of participants in each group who have HbA1c < 7%
timeFrame: 9 months after enrollment
Secondary outcomes:
measure: PAM-13 at 6 months after enrollment
timeFrame: 6 months after enrollment
measure: PAM-13 at 9 months after enrollment
timeFrame: 9 months after enrollment
measure: Mean change in PAM-13 at 6 months
timeFrame: 6 months after enrollment
measure: Mean change in PAM-13 at 9 months
timeFrame: 9 months after enrollment
Other outcomes:
Locations:
city: Rockport
country: United States
facility: PenBay Medical Center
state: Maine
Study officials:
affiliation: MaineHealth
name: Tracy Jalbuena, MD
role: PRINCIPAL_INVESTIGATOR
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