Support-t Online Training in Youth Living With Type 1 Diabetes Transitioning to Adult Care
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Support-t plus usual diabetes care Access to the Support-t online training and peer support platform in addition to usual diabetes care for 18 months. Support-t contains 3 components: 1) Educational material, 2) News blog and 3) Patients' discussion forum. Health care providers from the pediatric diabetes clinics will receive Support-t training and will be encouraged to recommend the Support-t platform during routine care with their patients from the active arm. |
Other: Support-t
Support-t plus usual diabetes care for 18 months
|
| No Intervention: Usual diabetes care only Usual diabetes care for 18 months, which consists of visits with their health care provider and ad-hoc diabetes education with nurses and dietitians. Health care providers from the pediatric diabetes clinics will be instructed not to discuss or refer to the Support-t platform with patients from the control arm. Control arm participants will have the option to use the Support-t platform after the 18-month study. |
Outcome Measures
Primary Outcome Measures
- Change from Baseline Hemaglobin A1c (HbA1c) at 18 months [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
Secondary Outcome Measures
- Change from Baseline Hemaglobin A1c (HbA1c) at 6 and 12 months [6, 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
- Continuous Glucose Monitoring (CGM) - % Time in range [0, 6, 12, 18 months]
% Time in range (3.9-10.0mmol/L) over the past 4 weeks will be derived from the medical record chart
- Continuous Glucose Monitoring (CGM) - % Time above range [0, 6, 12, 18 months]
% Time above range (3.9-10.0mmol/L) over the past 4 weeks will be derived from the medical record chart
- Continuous Glucose Monitoring (CGM) - % Time below range [0, 6, 12, 18 months]
% Time below range (3.9-10.0mmol/L) over the past 4 weeks will be derived from the medical record chart
- Continuous Glucose Monitoring (CGM) - Standard deviation [0, 6, 12, 18 months]
Standard deviation of the past 4 weeks will be derived from the medical record chart
- Continuous Glucose Monitoring (CGM) - % Coefficient of variation [0, 6, 12, 18 months]
% Coefficient of variation of the past 4 weeks will be derived from the medical record chart
- Severe hypoglycemic events [0, 6, 12, 18 months]
Any severe hypoglycemic events in the past 6 months will be derived from self-report and from the medical record chart
- Diabetic Ketoacidosis (DKA) events [0, 6, 12, 18 months]
Any Diabetic Ketoacidosis (DKA) events in the past 6 months will be derived from self-report and from the medical record chart
- Diabetes-related hospitalizations [0, 6, 12, 18 months]
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
- Diabetes-related emergency department visits [0, 6, 12, 18 months]
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
- Self-efficacy [0, 6, 12, 18 months]
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.
- Diabetes distress [0, 6, 12, 18 months]
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.
- Diabetes specific Quality of Life (QOL) [0, 6, 12, 18 months]
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.
- Transition readiness [0, 6, 12, 18 months]
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.
- Cost effectiveness (HbA1c) [12 and 18 months]
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
- Cost effectiveness (self-efficacy) [12 and 18 months]
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
- Cost effectiveness (diabetes distress) [12 and 18 months]
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
- Cost effectiveness (QOL) [12 and 18 months]
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
Other Outcome Measures
- Engagement with Support-t platform - T1D patient [6, 12, 18 months]
Engagement metrics will be extracted using Google analytics (e.g. time spent on the platform, participation in the discussion forum, specific content accessed, total pages viewed, downloaded documents, use of calculators).
- Engagement with Support-t platform - Health Care Provider [6, 12 months]
Engagement metrics will be extracted using Google analytics (e.g. time spent on the platform, specific content accessed, total pages viewed, downloaded documents, use of calculators).
- Satisfaction with Support-t platform - T1D patient [6, 12, 18 months]
Satisfaction will be rated on a scale from 1 to 10. Higher scores indicate greater satisfaction with the platform.
- Experience with Support-t platform (Barriers, facilitators, satisfaction, fidelity) - T1D patient [18 months]
Individual interviews to understand the experience in the context of implementation of the Support-t platform (Barriers, facilitators, satisfaction, fidelity) using qualitative descriptive methodology
- Experience with Support-t platform (Barriers, facilitators, satisfaction, fidelity) - Health Care Provider [12 months]
Individual interviews to understand the experience in the context of implementation of the Support-t platform (Barriers, facilitators, satisfaction, fidelity) using qualitative descriptive methodology
Eligibility Criteria
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
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Fluent in English or French
Exclusion Criteria:
-
Severe neurocognitive disabilities
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Patients with conditions associated with shortened erythrocyte survival, such as hemolytic anemia or other conditions associated with inaccurate HbA1c
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinique de pédiatrie Le Copain-Hôpital de Gatineau | Gatineau | Canada | ||
| 2 | Montreal Children's Hospital - McGill University Health Centre | Montréal | Canada | ||
| 3 | Centre Hospitalier Universitaire de Québec | Québec | Canada | ||
| 4 | Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Canada |
Sponsors and Collaborators
- McGill University
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- CSSS de Gatineau
- CHU de Quebec-Universite Laval
Investigators
- Principal Investigator: Anne-Sophie Brazeau, PhD, School of Human Nutrition - McGill University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- MP-37-2024-9734