Clinical trial NCT05445284: Group Education Trial to Improve Transition for Parents of Adolescents With T1D
Official title: Group Education Trial to Improve Transition for Parents of Adolescents With Type 1 Diabetes: A Pilot Randomized Controlled, Superiority Trial (GET-IT For Parents)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Disease
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Keywords: Transition care
Pediatric
Adolescent
Parent
Education
Self-management
Hemaglobin A1c
Feasibility
Pilot randomized controlled trial
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Diabetes Canada
First posted: 2022-07-06
Enrollment: 34
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active arm: Participants randomized to the active arm will be asked to attend ≥ 3 group education sessions for parents of adolescents with T1D, 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: Participants 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 study if group education for parents of adolescents with type 1 diabetes (T1D) will improve the transition from adolescence to adulthood. The investigators aim to conduct a pilot randomized controlled trial (RCT) of parent group education sessions to assess the feasibility and refine the intervention to inform a full-scale multicenter RCT. The aims of the pilot are to estimate: 1. Recruitment rate, 2. Adherence rate, 3. Response rate, and 4. Retention rate. The aims for the future full-scale multicenter RCT are to assess the effect of parent group education sessions integrated into pediatric care, compared with usual care on self-management, hemoglobin A1c (HbA1c), adverse outcomes and validated measures during the transition from adolescence to adulthood. The investigators will conduct a parallel group, blinded (outcome assessors, data analysts), superiority pilot RCT of parents and their adolescents with T1D (14-16 years of age) followed at a university teaching hospital-based pediatric diabetes clinic in Montreal. Interventions will occur over 12-months. Follow-up will be to 18 months from enrollment.

Detailed description: Rationale. Adolescence is a challenging life stage that is complicated for those with type 1 diabetes (T1D) as they learn to take responsibility for their health. Parents face uncertainty of what constitutes appropriate involvement and express distress around the health consequences of transferring responsibility to their adolescent. We know little about how to provide transition care services to parents as they attempt to support their adolescents during the transition to adulthood. We are currently conducting a multicenter randomized controlled trial (RCT) evaluating patient-driven group education for adolescents with T1D. Parents have expressed a need for education on how to transition responsibility of diabetes care from parent to adolescent. The investigators propose to study if group education for parents of adolescents with T1D will improve the transition from adolescence to adulthood. The investigators will conduct a pilot RCT of parent group education sessions to assess the feasibility and refine the intervention for a full-scale multicenter RCT.

Aims. The aims of the pilot are to estimate: 1. Recruitment rate, 2. Adherence rate, 3. Response rate, and 4. Retention rate. Through semi-structured interviews with parents, we also aim to identify aspects of the intervention that require refinement for the future full-scale multicenter RCT (e.g. session content and format). To assess feasibility success, we propose the following criteria:1. Recruitment rate: At least 50% of approached parents/adolescents will agree to randomization; 2. Adherence rate: At least 80% of parents attend ≥3 group education sessions; 3. Response rate: At least 80% of parents and adolescents will complete all validated questionnaires; 4. Retention rate: At least 70% of parents and adolescents will complete the trial. The aims for the future full-scale multicenter RCT are to determine the impact of parent group education sessions, compared with usual care on self-management, HbA1c, number of T1D-related emergency department visits and hospitalizations, diabetes distress, family conflict, diabetes resilience and diabetes responsibility.

Methods. The investigators will conduct a parallel group, blinded (outcome assessors, data analysts), superiority pilot RCT of parents and their adolescents with T1D (14-16 years of age) followed at a university teaching hospital-based pediatric diabetes clinic in Montreal. Dyads of adolescents and one parent will be recruited over 12 months. Interventions will occur over 12-months. Follow-up will be to 18 months from enrollment. Allocation will be concealed with a 1:1 intervention to control ratio. Visits in the active arm will consist of a parent group education session plus usual diabetes care every 3 months. The parent group education session, facilitated by a diabetes social worker, will consist of a parent-driven, in-person/virtual discussion on topics relevant to adolescence and transition care. Control arm participants will have usual care with their diabetes care provider every 3 months. Pilot RCT results will inform modification of trial execution related to feasibility and intervention for full-scale multicenter RCT. Main outcome measures are descriptions of study feasibility parameters. Health-related outcomes as well as parent and adolescent reported outcomes, using validated self-administered questionnaires will also be collected at baseline, 6, 12 and 18 months. Parents will be interviewed at baseline and 18 months to explore parents' experiences with and perceptions of the accessibility, acceptance, and usefulness of parent group education content and format, using qualitative descriptive methodology. Analysis will be descriptive and baseline data will be summarized, separately for those in the active and control arms.

Eligibility criteria: Inclusion Criteria:

* Parents and their adolescents, ages 14-16 years, with a diagnosis of T1D, of at least 6-months. Parent is defined as mother, father, or primary caregiver.
* Receiving diabetes care at a university teaching hospital-based pediatric diabetes clinic in Montreal: Montreal Children's Hospital (MCH)
* Participants must be fluent in English or French

Exclusion Criteria:

* Severe neurocognitive disabilities that may preclude parent's ability to participate in a group session
* Parents of adolescents participating in the Group Education Trial to Improve Transition in Type 1 Diabetes (GET-IT-T1D) for adolescents

Primary outcomes:
measure: Recruitment feasibility
timeFrame: 12 months
measure: Adherence feasibility
timeFrame: 12 months
measure: Response feasibility
timeFrame: 18 months
measure: Retention feasibility
timeFrame: 18 months
Secondary outcomes:
measure: Parent group education session accessibility, acceptance, usefulness
timeFrame: 0, 18 months
measure: Self-Management
timeFrame: 0, 6, 12, 18 months
measure: Diabetes Distress - Adolescent
timeFrame: 0, 6, 12, 18 months
measure: Diabetes Distress - Parent
timeFrame: 0, 6, 12, 18 months
measure: Family Conflict
timeFrame: 0, 6, 12, 18 months
measure: Diabetes Resilience - Adolescent
timeFrame: 0, 6, 12, 18 months
measure: Diabetes Resilience - Parent
timeFrame: 0, 6, 12, 18 months
measure: Responsibility (DFRQ)
timeFrame: 0, 6, 12, 18 months
measure: Responsibility (RCBRS)
timeFrame: 0, 6, 12, 18 months
measure: Hemaglobin A1c (HbA1c)
timeFrame: 0, 6, 12, 18 months
measure: Diabetes-related hospitalizations
timeFrame: 0, 12 months
measure: Diabetes-related emergency department visits
timeFrame: 0, 12 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Children's Hospital - McGill University Health Centre (MUHC)
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Meranda Nakhla, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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: 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: 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: 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.