NCT06786130

Brief Summary

The purpose of this observational study is to estimate the burden of T1D on caregivers of patient with T1D in terms of work productivity, healthcare resource utilization and quality of life.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 9, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

September 16, 2024

Last Update Submit

December 22, 2025

Conditions

Type 1 Diabetes MellitusQuality of Life (QOL)Work ProductivityCaregiver Subjective Burden

Keywords

observationalquality of lifecaregiverwork productivityreal-world

Outcome Measures

Primary Outcomes (1)

  • To estimate work productivity impairment of caregivers of a T1D child.

    Using the WOrk Productivity and Activity Impairment (WPAI) questionnaire

    At recruitment

Secondary Outcomes (3)

  • To estimate healthcare resource utilization in caregivers of T1D child

    At recruitment

  • To estimate health-related quality of life in caregivers of a T1D child

    At recruitment

  • To estimate the caregiver burden in caregivers of a T1D child

    At recruitment

Study Arms (1)

Caregiver of child with T1D

Caregiver of child with T1D diagnosed within the past 2 years

Other: observational study

Interventions

observational studyOTHER

This is an observational study in which participants complete PRO questionnaires via a web platform. No medical intervention or medication is involved.

Caregiver of child with T1D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parental caregivers of a child with T1D

You may qualify if:

  • Age ≥18 ;
  • Residence in the Canada;
  • Willingess to complete a 20-minute survey
  • Ability to read and understand French or English;
  • Signature of informed consent form (ICF)

You may not qualify if:

  • \. Participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PROxy Network, an initiative of PeriPharm Inc.

Montreal, Quebec, H2Y 2H4, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Observation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2024

First Posted

January 22, 2025

Study Start

January 9, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)