Clinical trial NCT05910840: Support-t Online Training in Youth Living With Type 1 Diabetes Transitioning to Adult Care
Official title: Support-t, an Online Training and Peer Support Platform to Accompany Youth Living With Type 1 Diabetes Transitioning to Adult Healthcare
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders (Including Diabetes Mellitus)
Metabolic Disease
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Keywords: Transition Care
Pediatric
Adolescent
Education
Hemaglobin A1c
Self-management
Randomized Controlled Trial
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: CSSS de Gatineau
name: CHU de Quebec-Universite Laval
First posted: 2023-06-20
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active arm: Participants randomized to the active arm will have access to the Support-t online training and peer support platform in addition to their usual diabetes care, over the 18 month intervention period. Support-t contains 3 components: 1) Educational material, 2) News blog and 3) Patients' discussion forum.

Control arm: Participants randomized to usual care only will attend their usual diabetes clinic visits, over the 18-month intervention period, which consists of visits with their health care provider and ad-hoc diabetes education with nurses and dietitians.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change from Baseline Hemaglobin A1c (HbA1c) at 18 months
timeFrame: 18 months
Secondary outcomes:
measure: Change from Baseline Hemaglobin A1c (HbA1c) at 6 and 12 months
timeFrame: 6, 12 months
measure: Continuous Glucose Monitoring (CGM) - % Time in range
timeFrame: 0, 6, 12, 18 months
measure: Continuous Glucose Monitoring (CGM) - % Time above range
timeFrame: 0, 6, 12, 18 months
measure: Continuous Glucose Monitoring (CGM) - % Time below range
timeFrame: 0, 6, 12, 18 months
measure: Continuous Glucose Monitoring (CGM) - Standard deviation
timeFrame: 0, 6, 12, 18 months
measure: Continuous Glucose Monitoring (CGM) - % Coefficient of variation
timeFrame: 0, 6, 12, 18 months
measure: Severe hypoglycemic events
timeFrame: 0, 6, 12, 18 months
measure: Diabetic Ketoacidosis (DKA) events
timeFrame: 0, 6, 12, 18 months
measure: Diabetes-related hospitalizations
timeFrame: 0, 6, 12, 18 months
measure: Diabetes-related emergency department visits
timeFrame: 0, 6, 12, 18 months
measure: Self-efficacy
timeFrame: 0, 6, 12, 18 months
measure: Diabetes distress
timeFrame: 0, 6, 12, 18 months
measure: Diabetes specific Quality of Life (QOL)
timeFrame: 0, 6, 12, 18 months
measure: Transition readiness
timeFrame: 0, 6, 12, 18 months
measure: Cost effectiveness (HbA1c)
timeFrame: 12 and 18 months
measure: Cost effectiveness (self-efficacy)
timeFrame: 12 and 18 months
measure: Cost effectiveness (diabetes distress)
timeFrame: 12 and 18 months
measure: Cost effectiveness (QOL)
timeFrame: 12 and 18 months
Other outcomes:
measure: Engagement with Support-t platform (T1D patient) - time in minutes on platform
timeFrame: 6, 12, 18 months
measure: Engagement with Support-t platform (T1D patient) - discussion forum participation
timeFrame: 6, 12, 18 months
measure: Engagement with Support-t platform (T1D patient) - content accessed
timeFrame: 6, 12, 18 months
measure: Engagement with Support-t platform (T1D patient) - total pages viewed
timeFrame: 6, 12, 18 months
measure: Engagement with Support-t platform (T1D patient) - downloaded documents
timeFrame: 6, 12, 18 months
measure: Engagement with Support-t platform (T1D patient) - use of calculators
timeFrame: 6, 12, 18 months
measure: Engagement with Support-t platform (Health Care Provider) - time in minutes on platform
timeFrame: 6, 12 months
measure: Engagement with Support-t platform (Health Care Provider) - content accessed
timeFrame: 6, 12 months
measure: Engagement with Support-t platform (Health Care Provider) - total pages viewed
timeFrame: 6, 12 months
measure: Engagement with Support-t platform (Health Care Provider) - downloaded documents
timeFrame: 6, 12 months
measure: Engagement with Support-t platform (Health Care Provider) - use of calculators
timeFrame: 6, 12 months
measure: Satisfaction with Support-t platform - T1D patient
timeFrame: 6, 12, 18 months
measure: Experience with Support-t platform (Barriers, facilitators, satisfaction, fidelity) - T1D patient
timeFrame: 18 months
measure: Experience with Support-t platform (Barriers, facilitators, satisfaction, fidelity) - Health Care Provider
timeFrame: 12 months
Locations:
city: Gatineau
country: Canada
facility: Clinique de pédiatrie Le Copain-Hôpital de Gatineau
city: Montréal
country: Canada
facility: Montreal Children's Hospital - McGill University Health Centre
city: Québec
country: Canada
facility: Centre Hospitalier Universitaire de Québec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
Study officials:
affiliation: School of Human Nutrition - McGill University
name: Anne-Sophie Brazeau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 8;13(5):e071396. doi: 10.1136/bmjopen-2022-071396.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Wafa S, Nakhla M. Improving the Transition from Pediatric to Adult Diabetes Healthcare: A Literature Review. Can J Diabetes. 2015 Dec;39(6):520-8. doi: 10.1016/j.jcjd.2015.08.003. Epub 2015 Oct 20.
citation: Nakhla M, Daneman D, To T, Paradis G, Guttmann A. Transition to adult care for youths with diabetes mellitus: findings from a Universal Health Care System. Pediatrics. 2009 Dec;124(6):e1134-41. doi: 10.1542/peds.2009-0041. Epub 2009 Nov 23.
citation: Nakhla M, Daneman D, Frank M, Guttmann A. Translating transition: a critical review of the diabetes literature. J Pediatr Endocrinol Metab. 2008 Jun;21(6):507-16.
citation: Nakhla M, Bell LE, Wafa S, Dasgupta K. Improving the transition from pediatric to adult diabetes care: the pediatric care provider's perspective in Quebec, Canada. BMJ Open Diabetes Res Care. 2017 Jun 30;5(1):e000390. doi: 10.1136/bmjdrc-2017-000390. eCollection 2017.
citation: Robinson ME, Simard M, Larocque I, Shah J, Rahme E, Nakhla M. Psychiatric disorders in emerging adults with diabetes transitioning to adult care: A retrospective cohort study. Diabet Med. 2021 Jun;38(6):e14541. doi: 10.1111/dme.14541. Epub 2021 Feb 19.