Support-t Online Training in Youth Living With Type 1 Diabetes Transitioning to Adult Care

Официальное название

Support-t, an Online Training and Peer Support Platform to Accompany Youth Living With Type 1 Diabetes Transitioning to Adult Healthcare

Обзор

The investigators will conduct a randomized controlled trial (RCT) to examine how an online training and peer support platform could help the preparation to transition to adult care. Among 14-16 year old youth with Type 1 Diabetes (T1D), the investigators aim to assess the effect of an online training and peer support platform (Support-t) integrated in usual care, compared with usual care on Hemoglobin A1c (HbA1c), adverse outcomes and psychosocial measures during the preparation for transition to adult care. The investigators will conduct a multi-site, parallel group, blinded (outcome assessors, data analysts), superiority RCT of adolescents with T1D (14-16 years of age) followed at one of 4 university teaching hospital-based pediatric diabetes clinics in the province of Quebec.

Подробное описание

The transition from pediatric to adult diabetes care is a challenging period for adolescents and young adults living with chronic conditions, such as Type 1 Diabetes (T1D). For youth with T1D, transition from pediatric to adult care is characterized by deterioration in glycemic control (Hemoglobin A1c \[HbA1c\]), reduced adherence to diabetes management tasks and increased risk of diabetes complications. The investigators propose to examine an online training and peer support platform as a potential alternative for delivering transition care. In adolescents with T1D, the investigators hypothesize that an online training and peer support platform (Support-t), when integrated into usual pediatric care, as compared with usual care alone, will result in better HbA1c, less adverse outcomes and better psychosocial outcomes during the preparation for transfer to adult care.

Primary Aim: To determine the impact of adding access to Support-t to usual care compared with usual care alone, on HbA1c during the preparation for transfer to adult care.

Secondary Aims: To determine the impact of adding access to Support-t to usual care compared with usual care alone, on self-efficacy, diabetes distress, quality of life (QOL; diabetes specific), readiness to transfer to adult care, glucose management, severe hypoglycemic episodes, diabetic ketoacidosis (DKA), T1D-related ED-visits and hospitalizations during the preparation for transfer to adult care. 2. To determine the cost-effectiveness of Support-t. 3. To understand the context for implementation in regards to level of engagement on Support-t, satisfaction and experience (barriers, facilitators) with Support-t.

Methods: The investigators will conduct a multi-site, parallel group, blinded (outcome assessors, data analysts), superiority RCT of adolescents with T1D (14-16 years of age) followed at one of 4 university teaching hospital-based pediatric diabetes clinics in Quebec. Patients will be recruited over 20 months. Interventions will occur over 18 months. Follow-up will be to 18 months from enrollment. Allocation will be concealed with a 1:1 intervention to control ratio. Participants in the active arm will have access to a mobile-based online training and peer support platform (Support-t) added to usual care. Participants in the control group will have in parallel with the intervention group, their usual diabetes care. The primary outcome is the change in HbA1c measured at 18 months (HbA1c measured at 18 months - HbA1c measured at baseline). Secondary outcomes are self-efficacy, diabetes distress, QOL, readiness to transfer, glucose management, severe hypoglycemic episodes, DKA, T1D-related ED-visits and hospitalizations. Assessments are at baseline, 6, 12 and 18 months. Analysis will be by intention-to-treat. Outcomes will be calculated and compared between the 2 trial arms using differences with 95% Confidence Intervals, along with a cost-effectiveness analysis. Interviews will be conducted to analyze the context for implementation.

Вмешательства

• Другое Support-t
  Support-t plus usual diabetes care for 18 months

Первичные конечные точки

• Change from Baseline Hemaglobin A1c (HbA1c) at 18 months [Срок оценки: 18 months]

Вторичные конечные точки (12)

• Change from Baseline Hemaglobin A1c (HbA1c) at 6 and 12 months [Срок оценки: 6, 12 months]
• Continuous Glucose Monitoring (CGM) - % Time in range [Срок оценки: 0, 6, 12, 18 months]
• Continuous Glucose Monitoring (CGM) - % Time above range [Срок оценки: 0, 6, 12, 18 months]
• Continuous Glucose Monitoring (CGM) - % Time below range [Срок оценки: 0, 6, 12, 18 months]
• Continuous Glucose Monitoring (CGM) - Standard deviation [Срок оценки: 0, 6, 12, 18 months]
• Continuous Glucose Monitoring (CGM) - % Coefficient of variation [Срок оценки: 0, 6, 12, 18 months]
• Severe hypoglycemic events [Срок оценки: 0, 6, 12, 18 months]
• Diabetic Ketoacidosis (DKA) events [Срок оценки: 0, 6, 12, 18 months]
• Diabetes-related hospitalizations [Срок оценки: 0, 6, 12, 18 months]
• Diabetes-related emergency department visits [Срок оценки: 0, 6, 12, 18 months]
• Self-efficacy [Срок оценки: 0, 6, 12, 18 months]
• Diabetes distress [Срок оценки: 0, 6, 12, 18 months]

Критерии участия

Критерии включения

• Adolescents with a clinical diagnosis of T1D
• 14-16 years of age
• Receiving diabetes care at one of 4 university teaching hospital-based pediatric diabetes clinics in Quebec: Montreal Children's Hospital-McGill University Health Centre, Centre hospitalier universitaire de Sherbrooke, Le Copain-Hôpital de Gatineau, Centre Hospitalier Universitaire de Québec
• Having access to internet
• Having an active email address
• Fluent in English or French

Критерии исключения

• Severe neurocognitive disabilities
• Patients with conditions associated with shortened erythrocyte survival, such as hemolytic anemia or other conditions associated with inaccurate HbA1c

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

Поддерживающая терапия

Центры проведения

Канада · 4 центра

• Clinique de pédiatrie Le Copain-Hôpital de Gatineau — Gatineau
• Montreal Children's Hospital - McGill University Health Centre — Montreal
• Centre Hospitalier Universitaire de Québec — Québec
• Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke

Публикации

• Sanmugalingham G, Mok E, Cafazzo JA, Desveaux L, Brazeau AS, Booth GL, Greenberg M, Kichler J, Rac VE, Austin P, Goldbloom E, Henderson M, Landry A, Zenlea I, Taylor M, Nakhla M, Shulman R. Text message-based intervention, Keeping in Touch (KiT), to support youth as they transition to adult type 1 diabetes care: a protocol for a multisite randomised controlled superiority trial. BMJ Open. 2023 May PMID 37156577
• Xie LF, Housni A, Nakhla M, Cianci R, Leroux C, Da Costa D, Brazeau AS. Adaptation of an Adult Web Application for Type 1 Diabetes Self-management to Youth Using the Behavior Change Wheel to Tailor the Needs of Health Care Transition: Qualitative Interview Study. JMIR Diabetes. 2023 Apr 26;8:e42564. doi: 10.2196/42564. PMID 37121571
• Ladd JM, Reeves-Latour J, Dasgupta K, Bell LE, Anjachak N, Nakhla M. Toward a better understanding of transition from paediatric to adult care in type 1 diabetes: A qualitative study of adolescents. Diabet Med. 2022 May;39(5):e14781. doi: 10.1111/dme.14781. Epub 2022 Jan 7. PMID 34967058
• Mok E, Henderson M, Dasgupta K, Rahme E, Hajizadeh M, Bell L, Prevost M, Frei J, Nakhla M. Group education for adolescents with type 1 diabetes during transition from paediatric to adult care: study protocol for a multisite, randomised controlled, superiority trial (GET-IT-T1D). BMJ Open. 2019 Nov 11;9(11):e033806. doi: 10.1136/bmjopen-2019-033806. PMID 31719096
• Alwadiy F, Mok E, Dasgupta K, Rahme E, Frei J, Nakhla M. Association of Self-Efficacy, Transition Readiness and Diabetes Distress With Glycemic Control in Adolescents With Type 1 Diabetes Preparing to Transition to Adult Care. Can J Diabetes. 2021 Jul;45(5):490-495. doi: 10.1016/j.jcjd.2021.05.006. Epub 2021 May 19. PMID 34176613
• Michaud S, Dasgupta K, Bell L, Yale JF, Anjachak N, Wafa S, Nakhla M. Adult care providers' perspectives on the transition to adult care for emerging adults with Type 1 diabetes: a cross-sectional survey. Diabet Med. 2018 Jul;35(7):846-854. doi: 10.1111/dme.13627. Epub 2018 May 2. PMID 29577410
• Lafontaine S, Mok E, Frei J, Henderson M, Rahme E, Dasgupta K, Nakhla M. Associations of Diabetes-related and Health-related Quality of Life With Glycemic Levels in Adolescents With Type 1 Diabetes Preparing to Transition to Adult Care. Can J Diabetes. 2023 Aug;47(6):525-531. doi: 10.1016/j.jcjd.2023.05.002. Epub 2023 May 12. PMID 37182591
• Soufi A, Mok E, Henderson M, Dasgupta K, Rahme E, Nakhla M. Association of stigma, diabetes distress and self-efficacy with quality of life in adolescents with type 1 diabetes preparing to transition to adult care. Diabet Med. 2024 Jan;41(1):e15159. doi: 10.1111/dme.15159. Epub 2023 Jun 21. PMID 37269172

Идентификаторы

NCT: NCT05910840 · MP-37-2024-9734

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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