Diabetes Mellitus Clinical Trial
— Support-tOfficial title:
Support-t, an Online Training and Peer Support Platform to Accompany Youth Living With Type 1 Diabetes Transitioning to Adult Healthcare
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.
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 |
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 |
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 |
Canada,
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
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 |
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