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

May 28, 2021 updated by: Margaret Lawson

Decision Coaching Using a Patient Decision Aid for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes: a Pretest Posttest Study

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: decision coaching
Decision coaching with a patient decision aid guided by the Ottawa Decision Support Framework
Behavioral: Decision coaching with a patient decision aid
Decision coaching guided by the Ottawa Decision Support Framework

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional Conflict
Time Frame: Change from baseline decision conflict scale 14 days after intervention
Decision Conflict Scale - minimum score 0; maximum score 100
Change from baseline decision conflict scale 14 days after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Choice predisposition
Time Frame: Change from baseline predisposition scale to 14 days after intervention
Choice Predisposition Scale - minimum score 0; maximum score 4
Change from baseline predisposition scale to 14 days after intervention
Preferred choice
Time Frame: Immediately after intervention
Questionnaire asking participants for their preferred choice for insulin delivery method
Immediately after intervention
Genetic Counselling Satisfaction Scale (modified version)
Time Frame: 14 days after the intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Margaret Lawson

Investigators

  • Principal Investigator: Margaret L Lawson, MD, Children's Hospital of Eastern Ontario

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2013

Primary Completion (Actual)

August 31, 2015

Study Completion (Actual)

December 5, 2015

Study Registration Dates

First Submitted

May 7, 2019

First Submitted That Met QC Criteria

May 28, 2021

First Posted (Actual)

June 1, 2021

Study Record Updates

Last Update Posted (Actual)

June 1, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/76X

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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