Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04909580
• Other study ID #: 11/76X
• Status: Completed
• Phase: N/A
• Start date: September 5, 2013
• Est. completion date: December 5, 2015

Study information

• Verified date: May 2021
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 5, 2015
• Est. primary completion date: August 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Decision coaching with a patient decision aid
Decision coaching guided by the Ottawa Decision Support Framework

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Margaret Lawson

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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: 10.11 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional Conflict	Decision Conflict Scale - minimum score 0; maximum score 100	Change from baseline decision conflict scale 14 days after intervention
Secondary	Choice predisposition	Choice Predisposition Scale - minimum score 0; maximum score 4	Change from baseline predisposition scale to 14 days after intervention
Secondary	Preferred choice	Questionnaire asking participants for their preferred choice for insulin delivery method	Immediately after intervention
Secondary	Genetic Counselling Satisfaction Scale (modified version)	Questionnaire that combined a shared decision making satisfaction rating tool and a modified version of the Genetic Counselling Satisfaction Scale	14 days after the intervention