Making Diabetes Care Fit for Young Adults Living With Type 1 Diabetes: Observations, Reflections and Expert Opinions

Обзор

The goal of this clinical study is to assess differences in collaborative efforts to make care fit between clinical encounters in usual care and those using the Making Care Fit tool among young adults with type 1 diabetes and their clinicians. The main question it aims to answer is: What are the differences in collaborative efforts to make care fit between clinical encounters in usual care and those using the Making Care Fit tool? Researchers will compare clinical encounters in usual care with encounters supported by the Making Care Fit tool to examine differences in collaborative efforts to align care and daily life. Participants will: * Take part in an observed clinical encounter with their clinician * Participate in a post-encounter video-stimulated interview reflecting on the consultation * Complete questionnaires about their experiences of the consultation

Вмешательства

• Поведенческое Making Care Fit tool
  A web-based tool designed to help young adults with type 1 diabetes prepare for care plan design during their clinical encounter by structuring and prioritizing their experiences and efforts in making care fit.
• Другое Care as usual
  Participants receive standard diabetes care at their clinic. Clinical encounters are observed and assessed to compare collaborative efforts with those in the Making Care Fit Tool arm.

Первичные конечные точки

• Observable efforts of collaboration to align care and life, with and without using the tool. [Срок оценки: 1 month from enrollment to the consultation]
• Perceived and unobservable efforts to align care and life. [Срок оценки: 2 months from enrollment into the study to the video stimulated interview]
• Perceived alignment of care plan and life. [Срок оценки: 4 months from enrollment to filling out the last questionnaire]

Вторичные конечные точки (10)

• Variety and quality of themes discussed [Срок оценки: 1 month from enrollment to consultation]
• Collaborative care plan design [Срок оценки: 1 month from enrollment to consultation]
• Fidelity of the use of the Making Care Fit tool [Срок оценки: 1 month from enrollment to the consultation]
• Unhurried conversations [Срок оценки: 1 month from enrollment to consultation]
• Perceived treatment burden, and acceptability of this burden. [Срок оценки: 4 months from enrollment to filling out the last questionnaire]
• Perceived diabetes distress [Срок оценки: 4 months from enrollment to filling out the last questionnaire]
• Self-reported fidelity of using the Making Care Fit tool outside of the clinical encounter [Срок оценки: 1 month from enrollment to concluding the consultation]
• Perceived clinical empathy [Срок оценки: 1 month from enrollment to after the consultation]
• Written information by patient in making care fit tool [Срок оценки: 1 month from enrollment to having the consultation]
• patient involvement [Срок оценки: 1 month after enrollment during the clinical consultation]

Критерии участия

Критерии включения

• Young adults (age 18-30)
• with ≥1 year since the diagnosis of type 1 diabetes
• receiving ongoing treatment at participating diabetes clinics (Leiden university medical center (LUMC), Diabeter),
• able to speak and read Dutch
• able to provide informed consent for study participation

Критерии исключения

• People who do not fit the participant requirements
• People who cannot give consent themselves (who are incapacitated)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Нидерланды · 2 центра

• Leiden University Medical Center — Leiden
• Diabeter — Rotterdam

Публикации

• Van Gastel A, Graner-Baars M, De Koning EJP, Montori VM, Tran VT, Dinneen SF, Mesman J, Swaak J, Aanstoot HJ, Stiggelbout AM, Kunneman M. Picture living with diabetes: A photovoice study of young adults' efforts in making diabetes care fit into their lives. Diabet Med. 2026 May;43(5):e70246. doi: 10.1111/dme.70246. Epub 2026 Feb 5. PMID 41645388

Идентификаторы

NCT: NCT07498738 · nWMOD4- 2025-026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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