Risk-informed Shared-decision Making Engagement Strategy for Patients With Prediabetes

Официальное название

Pilot Trial of a Risk-informed Shared-decision Engagement Strategy

Обзор

The goal of this clinical trial is to learn if knowing risk for diabetes can help adult patients with prediabetes take steps to get care and prevent diabetes. The main questions it aims to answer are: * Does a shared-decision making visit with a health care team member to talk about the participant's diabetes risk increase participants' taking steps to prevent diabetes? * Does a simple message in the patient portal about the participant's diabetes risk increase participants' taking steps to prevent diabetes? Researchers will compare the visit with usual care at the clinic to see if the visit increases participants' taking steps to prevent diabetes. Separately, the researchers will compare the patient message with usual care at the clinic to see if the message increases participants' taking steps to prevent diabetes. Participants will: * Complete surveys at the beginning of the study and up to 2 additional surveys * If the participant falls into the shared decision-making group, the participant will have one 30-minute visit with a healthcare team member to talk about risk of diabetes and how to lower it.

Вмешательства

• Другое Risk Informed Shared Decision-Making Strategy (RISE)
  Single visit with health care team member to discuss diabetes risk and choosing next steps
• Другое Low Touch Messaging Strategy (LTM)
  Single message delivered via patient portal system describing diabetes risk and tips to lower risk

Первичные конечные точки

• Presence of a DPP referral or new metformin prescription [Срок оценки: From randomization to 3 months after randomization]

Вторичные конечные точки (6)

• Proportion of patients enrolled in the DPP [Срок оценки: Referral to 6 months after DPP referral]
• Proportion of patients who complete ≥ 9 months of the DPP [Срок оценки: From enrollment to 12 months of follow-up]
• Weight change (kg) [Срок оценки: From enrollment to 12 months]
• Metformin adherence [Срок оценки: From enrollment to 12 months]
• Hemoglobin A1c change [Срок оценки: From enrollment to 12 months]
• Patient Activation Measure [Срок оценки: From enrollment to 3 months and from enrollment to 12 months]

Критерии участия

Критерии включения

• prediabetes based on most recent HbA1c (5.7-6.4%) or fasting plasma glucose (100-125 mg/dL) in prior 12 months
• active patient portal account (MyChart)
• patient receiving primary care at Johns Hopkins Community Physicians in Frederick
• have overweight or obesity (BMI ≥ 25 kg/m2)

Критерии исключения

• have diabetes (HbA1c > 6.4% in prior 6 months or on diabetes registry)
• have dementia
• previously participated in the Diabetes Prevention Program (DPP)

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

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Johns Hopkins Community Physicians Frederick — Frederick

Идентификаторы

NCT: NCT07553325 · IRB00538220

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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