NCT04909580

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2015

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2019

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

May 7, 2019

Last Update Submit

May 28, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Decisional Conflict

    Decision Conflict Scale - minimum score 0; maximum score 100

    Change from baseline decision conflict scale 14 days after intervention

Secondary Outcomes (3)

  • Choice predisposition

    Change from baseline predisposition scale to 14 days after intervention

  • Preferred choice

    Immediately after intervention

  • Genetic Counselling Satisfaction Scale (modified version)

    14 days after the intervention

Study Arms (1)

decision coaching

EXPERIMENTAL

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

Behavioral: Decision coaching with a patient decision aid

Interventions

Decision coaching guided by the Ottawa Decision Support Framework

decision coaching

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Using an insulin pump

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Related 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: 10.1186/s12887-019-1898-4.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Margaret L Lawson, MD

    Children's Hospital of Eastern Ontario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Pre post study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Pediatric Endocrinologist

Study Record Dates

First Submitted

May 7, 2019

First Posted

June 1, 2021

Study Start

September 5, 2013

Primary Completion

August 31, 2015

Study Completion

December 5, 2015

Last Updated

June 1, 2021

Record last verified: 2021-05

Locations