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

Diabetes Mellitus Clinical Trial

— Support-t  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05910840
• Other study ID #: MP-37-2024-9734
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: June 1, 2027

Study information

• Verified date: July 2023
• Source: McGill University
• Contact: Anne-Sophie Brazeau, PhD
• Phone: (514) 398-7848
• Email: anne-sophie.brazeau[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 1, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Endocrine System Diseases
• Glucose Metabolism Disorders
• Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Immune System Diseases
• Metabolic Disease
• Metabolic Diseases

Intervention

Other:
• Support-t
Support-t plus usual diabetes care for 18 months

Locations

Country	Name	City	State
Canada	Clinique de pédiatrie Le Copain-Hôpital de Gatineau	Gatineau
Canada	Montreal Children's Hospital - McGill University Health Centre	Montréal
Canada	Centre Hospitalier Universitaire de Québec	Québec
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke

Sponsors (5)

Lead Sponsor	Collaborator
McGill University	Centre de recherche du Centre hospitalier universitaire de Sherbrooke, CHU de Quebec-Universite Laval, CSSS de Gatineau, McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

References & Publications (13)

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. — View 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. — View 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 May 12:S1499-2671(23)00112-0. doi: 10.1016/j.jcjd.2023.05.002. Online ahead of print. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. 2023 Jun 3:e15159. doi: 10.1111/dme.15159. Online ahead of print. — View 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Engagement with Support-t platform (T1D patient) - time in minutes on platform	Engagement metrics will be extracted using Google analytics - time (minutes) spent on the platform	6, 12, 18 months
Other	Engagement with Support-t platform (T1D patient) - discussion forum participation	Engagement metrics will be extracted using Google analytics - participation on the platform discussion forum	6, 12, 18 months
Other	Engagement with Support-t platform (T1D patient) - content accessed	Engagement metrics will be extracted using Google analytics - specific content accessed from the platform	6, 12, 18 months
Other	Engagement with Support-t platform (T1D patient) - total pages viewed	Engagement metrics will be extracted using Google analytics - total pages viewed from the platform	6, 12, 18 months
Other	Engagement with Support-t platform (T1D patient) - downloaded documents	Engagement metrics will be extracted using Google analytics - downloaded documents from the platform	6, 12, 18 months
Other	Engagement with Support-t platform (T1D patient) - use of calculators	Engagement metrics will be extracted using Google analytics - use of calculators on the platform	6, 12, 18 months
Other	Engagement with Support-t platform (Health Care Provider) - time in minutes on platform	Engagement metrics will be extracted using Google analytics - time (minutes) spent on the platform	6, 12 months
Other	Engagement with Support-t platform (Health Care Provider) - content accessed	Engagement metrics will be extracted using Google analytics - specific content accessed from the platform	6, 12 months
Other	Engagement with Support-t platform (Health Care Provider) - total pages viewed	Engagement metrics will be extracted using Google analytics - total pages viewed from the platform	6, 12 months
Other	Engagement with Support-t platform (Health Care Provider) - downloaded documents	Engagement metrics will be extracted using Google analytics - downloaded documents from the platform	6, 12 months
Other	Engagement with Support-t platform (Health Care Provider) - use of calculators	Engagement metrics will be extracted using Google analytics - use of calculators on the platform	6, 12 months
Other	Satisfaction with Support-t platform - T1D patient	Satisfaction will be rated on a scale from 1 to 10. Higher scores indicate greater satisfaction with the platform.	6, 12, 18 months
Other	Experience with Support-t platform (Barriers, facilitators, satisfaction, fidelity) - T1D patient	Individual interviews to understand the experience in the context of implementation of the Support-t platform (Barriers, facilitators, satisfaction, fidelity) using qualitative descriptive methodology	18 months
Other	Experience with Support-t platform (Barriers, facilitators, satisfaction, fidelity) - Health Care Provider	Individual interviews to understand the experience in the context of implementation of the Support-t platform (Barriers, facilitators, satisfaction, fidelity) using qualitative descriptive methodology	12 months
Primary	Change from Baseline Hemaglobin A1c (HbA1c) at 18 months	HbA1c measured with a venous or capillary blood sample as part of the standard of diabetes care will be derived from the medical record chart or measured using an A1c Test Kit, which is a non-fasting, finger prick, whole blood test	18 months
Secondary	Change from Baseline Hemaglobin A1c (HbA1c) at 6 and 12 months	HbA1c measured with a venous or capillary blood sample as part of the standard of diabetes care will be derived from the medical record chart or measured using an A1c Test Kit, which is a non-fasting, finger prick, whole blood test	6, 12 months
Secondary	Continuous Glucose Monitoring (CGM) - % Time in range	% Time in range (3.9-10.0mmol/L) over the past 4 weeks will be derived from the medical record chart	0, 6, 12, 18 months
Secondary	Continuous Glucose Monitoring (CGM) - % Time above range	% Time above range (3.9-10.0mmol/L) over the past 4 weeks will be derived from the medical record chart	0, 6, 12, 18 months
Secondary	Continuous Glucose Monitoring (CGM) - % Time below range	% Time below range (3.9-10.0mmol/L) over the past 4 weeks will be derived from the medical record chart	0, 6, 12, 18 months
Secondary	Continuous Glucose Monitoring (CGM) - Standard deviation	Standard deviation of the past 4 weeks will be derived from the medical record chart	0, 6, 12, 18 months
Secondary	Continuous Glucose Monitoring (CGM) - % Coefficient of variation	% Coefficient of variation of the past 4 weeks will be derived from the medical record chart	0, 6, 12, 18 months
Secondary	Severe hypoglycemic events	Any severe hypoglycemic events in the past 6 months will be derived from self-report and from the medical record chart	0, 6, 12, 18 months
Secondary	Diabetic Ketoacidosis (DKA) events	Any Diabetic Ketoacidosis (DKA) events in the past 6 months will be derived from self-report and from the medical record chart	0, 6, 12, 18 months
Secondary	Diabetes-related hospitalizations	Any diabetes-related hospitalizations in the past 6 months, expressed as number of hospitalizations per person-years (P-Y) at risk will be derived from self-report and from the medical record chart	0, 6, 12, 18 months
Secondary	Diabetes-related emergency department visits	Any diabetes-related emergency-department visits in the past 6 months, expressed as number of emergency department visits per person-years (P-Y) at risk will be derived from self-report and from the medical record chart	0, 6, 12, 18 months
Secondary	Self-efficacy	Self-efficacy for Diabetes Self-Management Measure (SEDM) assesses self-efficacy. The score ranges from 1 to 10. All item scores are averaged to compute the score. A higher score represents a better outcome.	0, 6, 12, 18 months
Secondary	Diabetes distress	Problem Areas in Diabetes Scale-Teen (PAID-T) assesses adolescent diabetes distress. The scores range from 14 to 84. A total distress score is computed by summing responses. Higher scores indicate youth perception of feeling more burdened related to T1D.	0, 6, 12, 18 months
Secondary	Diabetes specific Quality of Life (QOL)	Type 1 Diabetes and Life (T1DAL) questionnaire assesses diabetes specific QOL for 12-17 year old adolescents living with T1D. Scores are transformed on a scale from 0 to 100. The total score ranges from 0 to 100. To calculate the total score, the mean is computed as the sum of all item scores divided by the number of items answered on all the scales. A higher total score represents a better outcome. The subscale scores (Daily Emotional Experiences & Daily Activities, Handling Diabetes Well, Peer Relationships, and Family Relationships) range from 0 to 100. To calculate the subscale scores, the mean is computed as the sum of the items in the subscale divided by the number of items answered on the subscale. Higher subscale scores represent a better outcome.	0, 6, 12, 18 months
Secondary	Transition readiness	Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) assesses diabetes-related knowledge or skill items by querying respondents on 42 total items split into 5 domains: knowledge, navigation, health behaviors, and insulin pump skills. Respondents answer on a Likert scale from "yes, I can do this" scored 5 to "Haven't thought about it" scored 1. Confidence level is evaluated in each domain with a higher score indicating more confidence.	0, 6, 12, 18 months
Secondary	Cost effectiveness (HbA1c)	Cost effectiveness of access to Support-t in addition to usual care compared with usual care in terms of incremental cost effectiveness ratio (ICER) for HbA1c	12 and 18 months
Secondary	Cost effectiveness (self-efficacy)	Cost effectiveness of access to Support-t in addition to usual care compared with usual care in terms of incremental cost effectiveness ratio (ICER) for self-efficacy	12 and 18 months
Secondary	Cost effectiveness (diabetes distress)	Cost effectiveness of access to Support-t in addition to usual care compared with usual care in terms of incremental cost effectiveness ratio (ICER) for diabetes distress	12 and 18 months
Secondary	Cost effectiveness (QOL)	Cost effectiveness of access to Support-t in addition to usual care compared with usual care in terms of incremental cost effectiveness ratio (ICER) for QOL	12 and 18 months