Clinical trial NCT04909580: Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes
Official title: Decision Coaching Using a Patient Decision Aid for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes: a Pretest Posttest Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 45
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre post study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A pre-/post-test design. Youth with type 1 diabetes and their parent(s) were referred to the intervention by their diabetes physician. Decision coaching guided youth and their parents in completing a patient decision aid that was pre-populated with evidence on insulin delivery options. Primary outcomes were youth and parent scores on the low literary version of the Decisional Conflict Scale (DCS).

Detailed description: A pre-/post-test design was used. Youth with type 1 diabetes and their parent(s) were referred to the intervention by their diabetes physician. Eligible participants were youth under 18 years old with T1D and their parents, who were considering a change in insulin delivery method, capable of participating in the decision making process, and able to read and speak English or French. No lower age limit was set for youth participants, provided the youth and parent(s) could participate in the consent or assent process. Family dyads (youth and one parent) and family triads (youth and two parents) were included.

The intervention was decision coaching guided by the Ottawa Decision Support Framework for youth with type 1 diabetes and their parents using a patient decision aid that was pre-populated with evidence on insulin delivery options.

Eligibility criteria: Inclusion Criteria:

* Youth with type 1 diabetes and their parents
* considering a change in their insulin delivery method
* capable of participating in the decision making process
* able to read and speak English or French

Exclusion Criteria:

* Using an insulin pump

Primary outcomes:
measure: Decisional Conflict
timeFrame: Change from baseline decision conflict scale 14 days after intervention
Secondary outcomes:
measure: Choice predisposition
timeFrame: Change from baseline predisposition scale to 14 days after intervention
measure: Preferred choice
timeFrame: Immediately after intervention
measure: Genetic Counselling Satisfaction Scale (modified version)
timeFrame: 14 days after the intervention
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Margaret L Lawson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lawson ML, Shephard AL, Feenstra B, Boland L, Sourial N, Stacey D. Decision coaching using a patient decision aid for youth and parents considering insulin delivery methods for type 1 diabetes: a pre/post study. BMC Pediatr. 2020 Jan 3;20(1):1. doi: 10.1186/s12887-019-1898-4.