Type 1 Diabetes MellitusNCT04909580
Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes
A study testing Decision coaching with a patient decision aid in people with Type 1 Diabetes Mellitus, run by Margaret Lawson at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Decision coaching with a patient decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 5 Sep 2013to 5 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Using an insulin pump
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Decision coaching with a patient decision aid
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision coaching with a patient decision aidBehavioural
Decision coaching guided by the Ottawa Decision Support Framework
| Study group | Role | What they receive |
|---|---|---|
| decision coaching | Experimental | Decision coaching with a patient decision aid guided by the Ottawa Decision Support Framework Receives: Behavioral: Decision coaching with a patient decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict
Decision Conflict Scale - minimum score 0; maximum score 100
Measured: Change from baseline decision conflict scale 14 days after intervention
Secondary outcomes (3)
Choice predisposition
Choice Predisposition Scale - minimum score 0; maximum score 4
Measured: Change from baseline predisposition scale to 14 days after intervention
Preferred choice
Questionnaire asking participants for their preferred choice for insulin delivery method
Measured: Immediately after intervention
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
Measured: 14 days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start5 Sep 2013
- Primary completion31 Aug 2015
- Study completion5 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre post study
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Margaret Lawson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Margaret Lawson, Children's Hospital of Eastern Ontario
- Investigators
- Margaret L Lawson, MD, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909580
- Sponsor's protocol ID
- 11/76X
- Status last verified
- May 2021
- First submitted
- 7 May 2019
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31900152
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04909580
- Acronym / sponsor ID
- 11/76X
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Margaret LawsonUniversity, hospital or other
- Study start
- 5 Sep 2013 (actual)
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 5 Dec 2015 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre post study
| Arm | Type | Receives |
|---|---|---|
| decision coaching | Experimental | Behavioral: Decision coaching with a patient decision aidDecision coaching with a patient decision aid guided by the Ottawa Decision Support Framework |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Using an insulin pump
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision coaching with a patient decision aidDecision coaching guided by the Ottawa Decision Support Framework | Behavioural | decision coaching |
Primary outcome
Decisional Conflict
Time frame: Change from baseline decision conflict scale 14 days after intervention
Decision Conflict Scale - minimum score 0; maximum score 100
3 secondary outcomes
Choice predisposition
Time frame: Change from baseline predisposition scale to 14 days after intervention
Preferred choice
Time frame: Immediately after intervention
Genetic Counselling Satisfaction Scale (modified version)
Time frame: 14 days after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Results publication: PubMed 31900152Lawson 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.
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret L Lawson, MD principal investigator
Children's Hospital of Eastern Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision coaching with a patient decision aid in people with Type 1 Diabetes Mellitus, run by Margaret Lawson at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict (time frame: Change from baseline decision conflict scale 14 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04909580, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.