Autoimmune Diseases, Diabetes Mellitus, Diabetes Mellitus, Type 1, Endocrine System Diseases, Glucose Metabolism Disorders (Including Diabetes Mellitus), Immune System Diseases, Metabolic Disease
Conditions
Keywords
Transition Care, Pediatric, Adolescent, Education, Hemaglobin A1c, Self-management, Randomized Controlled Trial
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.
Interventions
OTHERSupport-t
Support-t plus usual diabetes care for 18 months
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
CSSS de Gatineau
Centre de recherche du CHU de Sherbrooke
CHU de Quebec-Universite Laval
Anne-Sophie Brazeau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Data analysts
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.
Eligibility
Sex/Gender
ALL
Age
14 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Engagement with Support-t platform (T1D patient) - content accessed | 6, 12, 18 months | Engagement metrics will be extracted using Google analytics - specific content accessed from the platform |
| Engagement with Support-t platform (T1D patient) - total pages viewed | 6, 12, 18 months | Engagement metrics will be extracted using Google analytics - total pages viewed from the platform |
| Engagement with Support-t platform (T1D patient) - downloaded documents | 6, 12, 18 months | Engagement metrics will be extracted using Google analytics - downloaded documents from the platform |
| Engagement with Support-t platform (T1D patient) - use of calculators | 6, 12, 18 months | Engagement metrics will be extracted using Google analytics - use of calculators on the platform |
| Engagement with Support-t platform (Health Care Provider) - time in minutes on platform | 6, 12 months | Engagement metrics will be extracted using Google analytics - time (minutes) spent on the platform |
| Engagement with Support-t platform (Health Care Provider) - content accessed | 6, 12 months | Engagement metrics will be extracted using Google analytics - specific content accessed from the platform |
| Engagement with Support-t platform (Health Care Provider) - total pages viewed | 6, 12 months | Engagement metrics will be extracted using Google analytics - total pages viewed from the platform |
| Engagement with Support-t platform (Health Care Provider) - downloaded documents | 6, 12 months | Engagement metrics will be extracted using Google analytics - downloaded documents from the platform |
| Engagement with Support-t platform (Health Care Provider) - use of calculators | 6, 12 months | Engagement metrics will be extracted using Google analytics - use of calculators on the platform |
| 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 |
| Engagement with Support-t platform (T1D patient) - time in minutes on platform | 6, 12, 18 months | Engagement metrics will be extracted using Google analytics - time (minutes) spent on the platform |
| Engagement with Support-t platform (T1D patient) - discussion forum participation | 6, 12, 18 months | Engagement metrics will be extracted using Google analytics - participation on the platform discussion forum |
Countries
Canada
Contacts
Primary ContactAnne-Sophie Brazeau, PhD
Backup ContactAmelie Roy-Fleming, MSc
Outcome results
None listed