Telemedicine for Reach, Education, Access and Treatment-ongoing

NCT04107935 | Terminated Results

• 2 other identifiers: STUDY190800051R34DK123370-01
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes (DM) management requires health care providers to provide patients with the appropriate amount of time, education and support that are necessary for quality care. Unfortunately, this is often impeded by limited access to resources, particularly in rural communities where DM rates are high and providers are scarce. Therefore, study investigators propose addressing these issues by implementing a model of care that includes diabetes educator (DE)-led planned visits with a real-time videoconferencing telemedicine program for ongoing patient support to improve DM outcomes.

Conditions

Diabetes Mellitus

Keywords

Self management education and support; Telemedicine; Rural

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycemic Control

  Average change in HbA1c every 3 months from baseline through 12 months was assessed using mixed model regression with repeat measures and therefore there is only one result reported per arm.

  Change every 3 months for 12 months.

Secondary Outcomes (5)

• Change From Baseline in Diabetes Self-care Behavior [Diet] Across 3 Month Intervals for 12 Months.

  Change every 3 months for 12 months total.

• Change From Baseline in Diabetes Distress Across 3 Month Intervals for 12 Months

  Change every three months for 12 months total

• Change From Baseline in Diabetes Empowerment Across 3 Month Intervals for 12 Months

  Change every 3 months for 12 months total

• Intervention Acceptability

  12 months

• Change From Baseline in Medication Adherence Across 3 Month Intervals for 12 Months

  Change every 3 months for 12 months total

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: TREAT-ON

Usual Care

OTHER

Behavioral: Usual Care

Interventions

TREAT-ON BEHAVIORAL

TREAT-ON is a DE-driven self-management and support program that is delivered primarily through a real-time telemedicine videoconferencing platform. Like the usual care intervention, "high risk" patients with DM receiving care in underserved practices will be identified by a nurse practice-based manager (PCBM) and referred to a DE for self management services. Participants will complete an initial face-to-face visit with the DE to assess needs and develop a self-management treatment plan and goals. Via telemedicine videoconferencing, follow-up visits will be delivered by the DE to participants in their homes. Follow-up visits will be used to evaluate and support progress towards meeting and sustaining self-management goals and outcomes.

Intervention

Usual Care BEHAVIORAL

A retrospective control group will be formed from individuals who have previously participated in a program called the "Diabetes High Risk Initiative." In this program, patients receiving care in underserved practices are identified by a nurse PBCM to be at high risk for DM complications and/or unplanned care and referred to a DE for self management services delivered through primary care. Patients typically participate in one face-to-face visit with the DE to assess needs and develop self-management goals and then one to two follow-up encounters (generally conducted by telephone) with the PBCM or DE.

Usual Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intervention group: UPMC Health Plan patient-members who are 18-75y, have diagnosis of type 2 diabetes, are considered "high risk" (HbA1c \>9%), receiving care at participating Federally Qualified Health Centers, and willing and able to participate in a technology-supported intervention.
• Control group: The control group will be selected from individuals who have already participated in the UPMC Health Plan's Diabetes High Risk Initiative.

You may not qualify if:

• Non UPMC Health Plan patients
• Not enrolled in the UPMC Health Plan Diabetes High Risk Initiative
• Less than 18 or greater than 75 years of age
• Unwilling/unable to participate in the telemedicine diabetes education program

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Siminerio L, Krall J, Johnson P, Ruppert K, Hammoudeh R, Bandi A, Ng JM. Examining a Diabetes Self-Management Education and Support Telemedicine Model With High-Risk Patients in a Rural Community. J Diabetes Sci Technol. 2023 Sep;17(5):1190-1197. doi: 10.1177/19322968231180884. Epub 2023 Jun 20.

  PMID: 37338130 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

The trial was implemented when the COVID-19 pandemic started and there were restrictions and challenges with meeting in person to enroll patients. Also, the study design included a historic control group to make best use of available resources, but propensity score matching only matched 30 participant control/intervention pairs. Furthermore, a retrospective versus parallel control group design prevented collecting behavioral psychosocial and satisfaction data for the control group.

Results Point of Contact

• Title: Dr. Linda Siminerio
• Organization: University of Pittsburgh

similx@upmc.edu

412-559-0359

Study Officials

• Linda Siminerio, RN, PhD, CDE

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: February 4, 2020
• Primary Completion: August 4, 2022
• Study Completion: December 9, 2022
• Last Updated: December 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Study protocol and data set - After publication. ICF - After data collection is completed.
• Access Criteria: Study protocol and data set - other researchers will have to request access. ICF will be added to clinicaltrials.gov protocol

Locations

US (1)