Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

Официальное название

iMatter2: An Artificial Intelligence (AI)-Driven Approach to Supercharge a Novel Digital Patient-reported Outcomes Tool for Diabetes Management

Обзор

Investigators will conduct a hybrid type 1 effectiveness-implementation randomized controlled trial (RCT) to evaluate the effectiveness of iMatter2 versus usual care on reduction in HbA1c at 12-months (primary outcome) among patients with Type 2 diabetes (T2D).

Вмешательства

• Другое Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool
  Once the program begins, the AI chatbot sends daily text messages that include the PRO questions; a link to a library of educational resources tailored to their responses and personalized motivational messages with support. Participants will also be sent links to the interactive web-based dashboard that visualizes their daily PRO and HbA1c data. PCPs will be able to view reports of patients' PRO and A1c data through the EHR interface, which can be reviewed during visits with the patient or async

Первичные конечные точки

• Change in Hemoglobin A1C (HbA1c) [Срок оценки: Baseline, Month 12]

Вторичные конечные точки (12)

• Percentage of Patients Eligible for Participation in Trial who Enroll [Срок оценки: Up to Month 14]
• Percentage of PCP Practices Eligible for Participation in Trial that Enroll [Срок оценки: Up to Month 14]
• Percentage of Providers who View PRO Reports [Срок оценки: Up to Month 14]
• Percentage of Patients who Respond to PRO Text Messages [Срок оценки: Up to Month 14]
• Percentage of Patients who View PRO Interactive Dashboard [Срок оценки: Up to Month 14]
• Mean Number of EHR Reports Viewed by Providers [Срок оценки: Up to Month 14]
• Total Number of EHR Reports Viewed by Providers [Срок оценки: Up to Month 14]
• Percentage of PRO Messages Responded To by Patients [Срок оценки: Up to Month 14]
• Mean Number of PRO Messages Responded To by Patients [Срок оценки: Up to Month 14]
• Total Number of PRO Messages Responded To by Patients [Срок оценки: Up to Month 14]
• Mean Number of Reports Viewed by Patients via PRO Interactive Dashboard [Срок оценки: Up to Month 14]
• Total Number of Reports Viewed by Patients via PRO Interactive Dashboard [Срок оценки: Up to Month 14]

Критерии участия

Критерии включения

PCP Group:

• Fulltime primary care provider (MD/DO, NP) practicing at the participating family health centers or faculty group practices and
• Provide care to at least five patients with a diagnosis of T2D

Patient Group:

• Have a diagnosis of T2D for ≥6 months;
• Have uncontrolled T2D defined as HbA1c >7% documented in the EHR on at least two visits in the past year;
• Fluency in English or Spanish;
• Be willing to send/receive text messages; and
• Be > 18 years of age.

Критерии исключения

Patient Group:

• Refuse or are unable to provide informed consent;
• Have acute renal failure, end stage renal disease (ESRD) or evidence of dialysis, renal transplantation, or other ESRD-related services documented in the EHR;
• Have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR);
• Are pregnant or planning to become pregnant within 12 months;
• Currently participate in another T2D study; or
• Plan to discontinue care at the clinic within the next 12 months.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT05884775 · 23-00608

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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