Effect of Remote Patient Monitoring and Patient Education on Patient Activation and Glycemic Control in Individuals With Type 2 Diabetes
NCT ID: NCT05541120
Last Updated: 2023-02-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
NA
Study Classification
INTERVENTIONAL
Study Start Date
2022-10-18
Study Completion Date
2026-08-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Diabetes Mellitus, Type 2
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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 Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
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.
Group Type
EXPERIMENTAL
Remote Patient Monitoring
Intervention Type
DEVICE
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.
Interventions
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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.
Intervention Type
DEVICE
Eligibility Criteria
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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)
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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MaineHealth
OTHER
Sponsor Role
collaborator
Health Resources and Services Administration (HRSA)
FED
Sponsor Role
collaborator
Tracy Jalbuena MD
OTHER
Sponsor Role
lead
Responsible Party
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Tracy Jalbuena MD
Clinical Lead for Telehealth
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Tracy Jalbuena, MD
Role: PRINCIPAL_INVESTIGATOR
MaineHealth
Locations
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PenBay Medical Center
Rockport, Maine, United States
Site Status
Countries
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United States
References
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Almutairi N, Hosseinzadeh H, Gopaldasani V. The effectiveness of patient activation intervention on type 2 diabetes mellitus glycemic control and self-management behaviors: A systematic review of RCTs. Prim Care Diabetes. 2020 Feb;14(1):12-20. doi: 10.1016/j.pcd.2019.08.009. Epub 2019 Sep 20.
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Bahrom NH, Ramli AS, Isa MR, Baharudin N, Badlishah-Sham SF, Mohamed-Yassin MS, Abdul-Hamid H. Validity and reliability of the Patient Activation Measure(R) (PAM(R))-13 Malay version among patients with Metabolic Syndrome in primary care. Malays Fam Physician. 2020 Nov 10;15(3):22-34. eCollection 2020.
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Timpel P, Oswald S, Schwarz PEH, Harst L. Mapping the Evidence on the Effectiveness of Telemedicine Interventions in Diabetes, Dyslipidemia, and Hypertension: An Umbrella Review of Systematic Reviews and Meta-Analyses. J Med Internet Res. 2020 Mar 18;22(3):e16791. doi: 10.2196/16791.
Reference Type
BACKGROUND
Wubben DP, Vivian EM. Effects of pharmacist outpatient interventions on adults with diabetes mellitus: a systematic review. Pharmacotherapy. 2008 Apr;28(4):421-36. doi: 10.1592/phco.28.4.421.
Reference Type
BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
https://nccd.cdc.gov/BRFSSPrevalence/rdPage.aspx?rdReport=DPH_BRFSS.ExploreByLocation&rdProcessAction=&SaveFileGenerated=1&irbLocationType=States&islLocation=23&islState=&islCounty=&islClass=CLASS03&islTopic=TOPIC18&islYear=2020&hidLocationType=States&hidLocation=23&hidClass=CLASS03&hidTopic=TOPIC18&hidTopicName=Diabetes&hidYear=2020&irbShowFootnotes=Show&rdICL-iclIndicators=DIABETE4&iclIndicators_rdExpandedCollapsedHistory=&iclIndicators=DIABETE4&hidPreviouslySelectedIndicators=&DashboardColumnCount=2&rdShowElementHistory=divTopicUpdating%3dHide%2cislTopic%3dShow%2cdivYearUpdating%3dHide%2cislYear%3dShow%2c&rdScrollX=0&rdScrollY=99&rdRnd=57890
Centers For Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Division of Population Health. BRFSS Prevalence \& Trend Data
https://qpp.cms.gov/docs/QPP_quality_measure_specifications/Web-Interface-Measures/2020_Measure_DM-2_CMSWebInterface.pdf
Centers for Medicare and Medicaid Services. DM-2 (NQF 0059): Diabetes: Hemoglobin A1c (HbA1c) Poor Control (\>9%).; 2019. Accessed January 20, 2022.
https://diabetesatlas.org/
International Diabetes Federation. IDF Diabetes Atlas. IDF Diabetes Atlas. Published 2021
https://stacker.com/stories/2779/states-biggest-rural-populations?page=5
Lisa A. States with the biggest rural populations. Stacker. Published April 8, 2019.
https://health.gov/sites/default/files/2022-01/NCCC%20Report%20to%20Congress.pdf
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
00000
Identifier Type: -
Identifier Source: org_study_id
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