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

NCT ID: NCT04909580

Last Updated: 2021-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-05

Study Completion Date

2015-12-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pre post study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

decision coaching

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

Group Type EXPERIMENTAL

Decision coaching with a patient decision aid

Intervention Type BEHAVIORAL

Decision coaching guided by the Ottawa Decision Support Framework

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Decision coaching with a patient decision aid

Decision coaching guided by the Ottawa Decision Support Framework

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Margaret Lawson

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Margaret Lawson

Pediatric Endocrinologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Margaret L Lawson, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Eastern Ontario

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 31900152 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11/76X

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Diabetes Management Personal Trainer
NCT00340093 COMPLETED PHASE1
Family-Based Treatment for Type 1 Diabetes
NCT05756361 ACTIVE_NOT_RECRUITING NA