Clinical trial NCT03703440: Group Education Trial to Improve Transition in Type 1 Diabetes
Official title: Evaluation of a Group Education Program to Improve the Transition From Pediatric to Adult Care for Emerging Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Type1diabetes
Insulin Dependent Diabetes
Keywords: Transition care
Pediatric
Adolescent
Education
Hemaglobin A1c
Health Services
Randomized Controlled Trial
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: St. Justine's Hospital
name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-10-12
Enrollment: 212
Sex: ALL
Minimum age (years): 16
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active arm: Patients randomized to the active arm will be asked to attend ≥ 3 group education sessions, in addition to their usual diabetes clinic visits every 3 months, over the 12-month intervention period. Group education sessions will coincide with regularly scheduled clinic visits.

Control arm: Patients randomized to usual care will attend their usual 3-month interval diabetes clinic visits, over the 12-month intervention period, which consists of visits with their diabetes care physician.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators will conduct a randomized controlled trial (RCT) to examine group education visits as an innovative and potentially cost-effective approach to transition care delivery, that can be easily integrated into usual diabetes care. Among emerging adults with type 1 diabetes (T1D), the investigators aim to assess the effect of group education visits integrated into pediatric care, compared with usual care on Hemoglobin A1c (HbA1c), adverse outcomes and psychosocial measures after the transfer to adult care. The investigators will conduct a multi-site, parallel group, blinded (outcome assessors, data analysts), superiority Randomized Controlled Trial (RCT) of adolescents with T1D (17 years of age) followed at one of the two university teaching hospital-based pediatric diabetes clinics in Montreal. Interventions will occur over 12-months. Follow-up will be to 24 months from enrollment.

Detailed description: Rationale. The transition from pediatric to adult diabetes care is a challenging period for adolescents and emerging adults (ages 18-30 years) with type 1 diabetes (T1D). It is characterized by a deterioration in glycemic control (Hemoglobin A1c \[HbA1c\]), decreased adherence to self-management tasks and to clinic attendance and an increased risk of adverse outcomes. The investigators propose to examine group education visits as a potentially cost-effective approach. In emerging adults with T1D, the investigators hypothesize that group education visits, as compared with usual care, will result in better HbA1c, less adverse outcomes and better psychosocial outcomes after the transfer to adult care.

Primary Aim. To determine the impact of group educations visits, compared with usual care, on HbA1c after the transfer to adult care.

Secondary Aims. 1. To determine the impact of group education visits, compared with usual care, on time between last pediatric and first adult T1D visit (gap \> 6 months), emergency department (ED) visits and hospitalizations, severe hypoglycemic events, stigma, self-efficacy, disease knowledge, transition readiness, quality of life (QOL) and diabetes distress, after the transfer to adult care. 2. To determine the cost-effectiveness of group education visits.

Methods. The investigators will conduct a multi-site, parallel group, blinded (outcome assessors, data analysts), superiority Randomized Controlled Trial (RCT) of adolescents with T1D (17 years of age) followed at one of the two university teaching hospital-based pediatric diabetes clinics in Montreal. Patients will be recruited over 24 months. Interventions will occur over 12-months. Follow-up will be to 24 months from enrollment. Allocation will be concealed with a 1:1 intervention to control ratio . Visits in the active arm will consist of a group education session followed by an individual appointment with the diabetes care physician every 3-months. The group education session, facilitated by a diabetes nurse educator or dietitian, will consist of a patient-driven discussion on topics relevant to adolescents with T1D. Patients in the control group, will have in parallel with the intervention group, individual appointments with their diabetes provider as per usual care. The primary outcome is the change in HbA1c measured at 24 months (HbA1c measured at 24 months - HbA1c measured at baseline). Secondary outcomes are delays in establishing adult T1D care (Y/N), T1D-related hospitalizations and ED-visits (rates/P-Y), severe hypoglycemic events, stigma, self-efficacy, diabetes knowledge, transition readiness, diabetes distress, and QOL. Assessments are at baseline, 12 and 24 months . Analysis will be by intention to treat. Outcomes will be calculated and compared between the two trial arms using differences with 95% Confidence Intervals, along with a cost-effectiveness analysis.

Eligibility criteria: Inclusion Criteria:

* Adolescents with a diagnosis of Type 1 Diabetes
* 16 to 17 years of age
* Receiving diabetes care at one of two university teaching hospital-based pediatric diabetes clinics in Montreal: Montreal Children's Hospital (MCH) or Centre Hospitalier Universitaire Sainte Justine (CHUSJ)
* Fluent in English or French

Exclusion Criteria:

* Severe neurocognitive disabilities that may preclude patient's ability to participate in a group education visit
* Patients with conditions associated with shortened erythrocyte survival, such as hemolytic anemia or other conditions associated with inaccurate HbA1c

Primary outcomes:
measure: Hemaglobin A1c (HbA1c)
timeFrame: 0, 12, 24 months
Secondary outcomes:
measure: Delay in establishing adult Diabetes Care (gap in care>6 months)
timeFrame: 24 months
measure: Delay in establishing adult Diabetes Care (days)
timeFrame: 24 months
measure: Diabetes-related hospitalizations
timeFrame: 0, 12, 24 months
measure: Diabetes-related emergency department visits
timeFrame: 0, 12, 24 months
measure: Severe hypoglycemic events
timeFrame: 0,12, 24 months
measure: Stigma
timeFrame: 0,12, 24 months
measure: Self-efficacy
timeFrame: 0,12, 24 months
measure: Diabetes knowledge
timeFrame: 0, 12, 24 months
measure: Transition readiness
timeFrame: 0, 12 months
measure: Diabetes distress
timeFrame: 0, 12, 24 months
measure: Quality of life (Generic Core)
timeFrame: 0, 12, 24 months
measure: Quality of life (Diabetes Module)
timeFrame: 0, 12, 24 months
measure: Cost effectiveness (HbA1c)
timeFrame: 12 and 24 months
measure: Cost effectiveness (QOL)
timeFrame: 12 and 24 months
measure: Cost effectiveness (self-efficacy)
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier Universitaire Sainte-Justine (CHUSJ)
state: Quebec
city: Montreal
country: Canada
facility: Montreal Children's Hospital - McGill University Health Centre (MUHC)
state: Quebec
Study officials:
affiliation: Montreal Children's Hospital - McGill University Health Centre (MUHC)
name: Meranda Nakhla, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brazeau AS, Nakhla M, Wright M, Henderson M, Panagiotopoulos C, Pacaud D, Kearns P, Rahme E, Da Costa D, Dasgupta K. Stigma and Its Association With Glycemic Control and Hypoglycemia in Adolescents and Young Adults With Type 1 Diabetes: Cross-Sectional Study. J Med Internet Res. 2018 Apr 20;20(4):e151. doi: 10.2196/jmir.9432.
citation: Diabetes Canada Clinical Practice Guidelines Expert Committee; Wherrett DK, Ho J, Huot C, Legault L, Nakhla M, Rosolowsky E. Type 1 Diabetes in Children and Adolescents. Can J Diabetes. 2018 Apr;42 Suppl 1:S234-S246. doi: 10.1016/j.jcjd.2017.10.036. No abstract available.
citation: Nakhla M, Rahme E, Simard M, Larocque I, Legault L, Li P. Risk of ketoacidosis in children at the time of diabetes mellitus diagnosis by primary caregiver status: a population-based retrospective cohort study. CMAJ. 2018 Apr 9;190(14):E416-E421. doi: 10.1503/cmaj.170676.
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: 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: Nakhla M, Rahme E, Simard M, Guttmann A. Outcomes associated with a pediatric clinical diabetes network in Ontario: a population-based time-trend analysis. CMAJ Open. 2017 Jul 24;5(3):E586-E593. doi: 10.9778/cmajo.20170022.
citation: Brazeau AS, Nakhla M, Wright M, Panagiotopoulos C, Pacaud D, Henderson M, Rahme E, Da Costa D, Dasgupta K. Stigma and Its Impact on Glucose Control Among Youth With Diabetes: Protocol for a Canada-Wide Study. JMIR Res Protoc. 2016 Dec 15;5(4):e242. doi: 10.2196/resprot.6629.
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: Jefferies CA, Nakhla M, Derraik JG, Gunn AJ, Daneman D, Cutfield WS. Preventing Diabetic Ketoacidosis. Pediatr Clin North Am. 2015 Aug;62(4):857-71. doi: 10.1016/j.pcl.2015.04.002. Epub 2015 May 30.
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: Guttmann A, Nakhla M, Henderson M, To T, Daneman D, Cauch-Dudek K, Wang X, Lam K, Hux J. Validation of a health administrative data algorithm for assessing the epidemiology of diabetes in Canadian children. Pediatr Diabetes. 2010 Mar;11(2):122-8. doi: 10.1111/j.1399-5448.2009.00539.x. Epub 2009 Jun 5.
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: 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.