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Completed

NCT Number: NCT04909580

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

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).

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decision coaching with a patient decision aid

Behavioral

Decision coaching guided by the Ottawa Decision Support Framework

Primary outcomes

  1. Decisional Conflict

    Time frame: Change from baseline decision conflict scale 14 days after intervention

    Decision Conflict Scale - minimum score 0; maximum score 100

Secondary outcomes

  1. Choice predisposition

    Time frame: Change from baseline predisposition scale to 14 days after intervention

    Choice Predisposition Scale - minimum score 0; maximum score 4

  2. Preferred choice

    Time frame: Immediately after intervention

    Questionnaire asking participants for their preferred choice for insulin delivery method

  3. 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

Sponsors and collaborators

Lead sponsor

Margaret Lawson

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 1, 2021
Registry last updated
Jun 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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