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

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Decision coaching with a patient decision aid

About this trial

This is an interventional health services research trial for Type 1 Diabetes Mellitus

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children's Hospital of Eastern Ontario

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

decision coaching

Arm Description

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

Outcomes

Primary Outcome Measures

Decisional Conflict

Decision Conflict Scale - minimum score 0; maximum score 100

Secondary Outcome Measures

Choice predisposition

Choice Predisposition Scale - minimum score 0; maximum score 4

Preferred choice

Questionnaire asking participants for their preferred choice for insulin delivery method

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

Full Information

NCT ID

NCT04909580

First Posted

May 7, 2019

Last Updated

May 28, 2021

Sponsor

Margaret Lawson

1. Study Identification

Unique Protocol Identification Number

NCT04909580

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

September 5, 2013 (Actual)

Primary Completion Date

August 31, 2015 (Actual)

Study Completion Date

December 5, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Margaret Lawson

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Pre post study

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

decision coaching

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Decision coaching with a patient decision aid

Intervention Description

Decision coaching guided by the Ottawa Decision Support Framework

Primary Outcome Measure Information:

Title

Decisional Conflict

Description

Decision Conflict Scale - minimum score 0; maximum score 100

Time Frame

Change from baseline decision conflict scale 14 days after intervention

Secondary Outcome Measure Information:

Title

Choice predisposition

Description

Choice Predisposition Scale - minimum score 0; maximum score 4

Time Frame

Change from baseline predisposition scale to 14 days after intervention

Title

Preferred choice

Description

Questionnaire asking participants for their preferred choice for insulin delivery method

Time Frame

Immediately after intervention

Title

Genetic Counselling Satisfaction Scale (modified version)

Description

Questionnaire that combined a shared decision making satisfaction rating tool and a modified version of the Genetic Counselling Satisfaction Scale

Time Frame

14 days after the intervention

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Margaret L Lawson, MD

Organizational Affiliation

Children's Hospital of Eastern Ontario

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital of Eastern Ontario

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L1

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

31900152

Citation

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.

Results Reference

result

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

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