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Telemedicine for Reach, Education, Access and Treatment-ongoing (TREAT-ON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04107935
Recruitment Status : Not yet recruiting
First Posted : September 27, 2019
Last Update Posted : September 27, 2019
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Linda Siminerio, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: TREAT-ON Behavioral: Usual Care Not Applicable

Detailed Description:
Health care systems need to seek ways through quality improvement, care coordination, and workforce capacity to support quality care. It has been proposed that new models of care coupled with technology are needed. DM provides an ideal model for testing new approaches as the number of people with DM continues to rise, with an inverse shortage of health providers available to meet their needs. Most patients with Type 2 DM (T2DM) are seen in primary care (PC) where providers report barriers to comprehensive care that include limited time, educational resources, added workload and feeling ill-equipped to counsel patients on behavior change. Efforts to restructure PC are underway, like DE-led planned management visits, reported to improve healthy behaviors and outcomes in patients at high risk. DEs are well suited to support the skills, decision making, self-care behaviors, problem solving and active collaboration with the care team that serve as the foundation for diabetes self-management education and key to an effective planned visit. DEs supporting care and self-management education in PC have been shown to improve access and outcomes. For patients to sustain a lifetime of behavior to effectively self-manage, continued support to sustain the ongoing skills, knowledge, and behaviors required to manage their condition is needed. Given the need for enduring support and scarcity of providers, particularly in underserved rural areas, efforts to understand how best to re-design practice to involve DEs in PC and utilize technology to enable and scale engagement in self-management and ongoing support must be considered. The purpose of this application is to evaluate the deployment of Telemedicine for Reach, Education, Access, Treatment and Ongoing Support (TREAT-ON), a DE-driven, PC-based telemedicine model that relies on PC practice redesign to afford access to real-time ongoing support. Investigators hypothesize that the TREAT-ON model will help individuals identified as being high risk in an underserved rural community to achieve and sustain improvements in clinical, psychosocial and behavioral outcomes, and aim to demonstrate the model's viability in terms of feasibility and acceptability to inform future testing of TREAT-ON.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Telemedicine for Reach, Education, Access and Treatment-ongoing
Estimated Study Start Date : January 6, 2020
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : June 15, 2021

Arm Intervention/treatment
Experimental: Intervention Behavioral: TREAT-ON
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.

Usual Care Behavioral: Usual Care
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.

Primary Outcome Measures :
  1. Change from baseline in glycemic control at 12 months [ Time Frame: As available from baseline through 12 months ]
    Hemoglobin A1c

Secondary Outcome Measures :
  1. Change from baseline in diabetes self-care behaviors at 12 months [ Time Frame: Baseline, 3 months, 6 month, and 12 months ]
    Summary of Diabetes Self-care Activities Measure (SDSCA). This instrument will be used to evaluate self-care with questions about number of days in a week that the participant reports self-care behaviors related to general diet, specific diet, exercise, blood glucose testing. Individual items are scored 0 to 7 for number of days each behavior is performed. The more frequently the behavior occurs, the better, with the exception of smoking. Correlations with other measures of diet and exercise generally support validity of SDSCA subscales (Toobert et al, 2000).

  2. Change from baseline in medication adherence at 12 months [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]
    Medication adherence will be assessed with the 8-item Morisky Medication Adherence Scale (MMAS-8). The scales includes 8 items. Scores can range from 0 to 8; the higher the score, the more adherent the respondent is considered.

  3. Change from baseline in diabetes distress at 12 months [ Time Frame: Baseline, 3 months, 6 months, and 12 months ]
    Diabetes distress will be evaluated with the 17-item Diabetes Distress Scale (DDS17), which assesses four dimensions of distress - emotional, regimen, interpersonal and physician (Polonsky et al, 2005), and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM (Fisher et al, 2012). Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress.

  4. Change from baseline in diabetes empowerment at 12 months [ Time Frame: Baseline, 3 month, 6 months, and 12 months ]
    Empowerment will be measured using the 8-item Diabetes Empowerment Scale-Short Form (DES-SF), which measures an individual's perceived ability to manage psychosocial aspects of diabetes, assess dissatisfaction and readiness to change self-management plans and set and achieve diabetes goals (Anderson et al, 2000; Anderson et al, 2003). Possible scores are 1 to 5 for each item, summed for a possible total score of 8 to 40. Higher scores indicate greater empowerment.

  5. Intervention acceptability [ Time Frame: 12 months ]
    Telemedicine Usability Questionnaire will be used to assess telehealth usefulness, ease of use and learnability, interface quality, patient-clinician interaction, reliability, satisfaction and future use and will include additional items specific to this study. Individual items are scored on a scale from one to five, with one being strongly disagree to five being strongly agree. The higher the score infers the better the usability of the telehealth service.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04107935

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Contact: Linda Siminerio, RN, PhD, CDE 412-864-0158
Contact: Jodi Krall, PhD 412-980-0994

Sponsors and Collaborators
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Linda Siminerio, RN, PhD, CDE University of Pittsburgh

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Responsible Party: Linda Siminerio, Professor, University of Pittsburgh Identifier: NCT04107935     History of Changes
Other Study ID Numbers: STUDY19080005
1R34DK123370-01 ( U.S. NIH Grant/Contract )
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After completion of the study, study investigators will prepare a consolidated dataset with all data collected as part of this study (e.g., clinical, behavioral, psychosocial, and satisfaction). All potentially identifying information will be removed. All publications will state that this dataset is available from the PI. In addition, study investigators will prepare a Manual of Operations with a detailed description of the diabetes self-management and support intervention, the technology delivery system and a full description of the TREAT-ON model for dissemination.
Supporting Materials: Study Protocol
Informed Consent Form (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 protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Linda Siminerio, University of Pittsburgh:
Self management education and support