Telemedicine for Reach, Education, Access and Treatment-ongoing (TREAT-ON)
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|ClinicalTrials.gov Identifier: NCT04107935|
Recruitment Status : Not yet recruiting
First Posted : September 27, 2019
Last Update Posted : September 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Behavioral: TREAT-ON Behavioral: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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|
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.
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.
- Change from baseline in glycemic control at 12 months [ Time Frame: As available from baseline through 12 months ]Hemoglobin A1c
- 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).
- 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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT04107935
|Contact: Linda Siminerio, RN, PhD, CDEfirstname.lastname@example.org|
|Contact: Jodi Krall, PhDemail@example.com|
|Principal Investigator:||Linda Siminerio, RN, PhD, CDE||University of Pittsburgh|