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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05541120
• Other study ID #: 00000
• Status: Withdrawn
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: August 31, 2026

Study information

• Verified date: February 2023
• Source: MaineHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

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.

Locations

Country	Name	City	State
United States	PenBay Medical Center	Rockport	Maine

Sponsors (3)

Lead Sponsor	Collaborator
Tracy Jalbuena MD	Health Resources and Services Administration (HRSA), MaineHealth

Country where clinical trial is conducted

United States, 

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* Note: There are 53 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean HbA1c%	Average glycated hemoglobin	6 months after enrollment
Primary	Mean HbA1c%	Average glycated hemoglobin	9 months after enrollment
Primary	Mean change in HbA1c%	Average change in percentage of HbA1c from baseline to 6 months after enrollment	6 months after enrollment
Primary	Mean change in HbA1c%	Average change in percentage of HbA1c from baseline to 9 months after enrollment	9 months after enrollment
Primary	Percentage of participants in each group who have HbA1c < 7%	Percentage of participants in each group with HbA1c < 7%	6 months after enrollment
Primary	Percentage of participants in each group who have HbA1c < 7%	Percentage of participants in each group with HbA1c < 7%	9 months after enrollment
Secondary	PAM-13 at 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
Secondary	PAM-13 at 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
Secondary	Mean change in PAM-13 at 6 months	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
Secondary	Mean change in PAM-13 at 9 months	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

External Links

•   Centers For Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Division of Population Health. BRFSS Prevalence & Trend Data
•   Centers For Disease Control and Prevention. National Diabetes Statistics Report, 2020: Estimates of Diabetes and Its Burden in the United States. U.S. Department of Health and Human Services; 2020.
•   Centers for Medicare and Medicaid Services. DM-2 (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%).; 2019. Accessed January 20, 2022.
•   Insignia Health, a Phreesia company. Research License Details; Use the PAM® Survey in a Research Study. Insignia Health, a Phreesia company. Published December 20, 2021.
•   International Diabetes Federation. IDF Diabetes Atlas. IDF Diabetes Atlas. Published 2021
•   Lisa A. States with the biggest rural populations. Stacker. Published April 8, 2019.
•   Maine Center for Disease Control & Prevention: Rural Health and Primary Care, A Division of the Maine Department of Health and Human Services.
•   National Clinical Care Commission. Report to Congress on Leveraging Federal Programs to Prevent and Control Diabetes and Its Complications. Department of Health and Human Services; 2021. Accessed January 31, 2022.