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Social Navigator Program for Type 1 Diabetes

N/A

Recruiting

Led By Caroline Zuijdwijk, MD

Research Sponsored by Children's Hospital of Eastern Ontario

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Phase 1: Patient in the Type 1 diabetes (T1D) or Type 2 diabetes (T2D) clinics at CHEO

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will help healthcare providers better meet the social needs of children and their families in pediatric specialty care settings.

Who is the study for?

This trial is for children and teens (0-17 years) with Type 1 or Type 2 diabetes receiving care at CHEO. Participants must include a parent/caregiver-child pair. To join Phase 2, they need to have at least one social determinant of health need identified by a screening tool. Those already working with a social worker or unable to consent are excluded.Check my eligibility

What is being tested?

The study tests the effectiveness of a 'Social Navigator' program designed to help families address social and economic challenges affecting their child's health. It aims to connect them with resources and support through an innovative clinic model tailored for pediatric specialty care settings.See study design

What are the potential side effects?

Since this intervention involves non-medical assistance rather than drugs or medical procedures, traditional side effects are not expected. However, there may be indirect consequences such as emotional distress or privacy concerns when discussing personal socioeconomic situations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a patient with Type 1 or Type 2 diabetes at the CHEO clinic.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To compare participant satisfaction with NSRCH (social navigator) vs. standard care (social worker), as measured by the Client Satisfaction Questionnaire (CSQ).

Secondary outcome measures

To compare change in Quality of Life (QOL) of participants (pre/post intervention) referred to NSRCH (social navigator) vs standard care (social worker), as measured by the WHOQOL-BREF.

To compare the number of community resources accessed by participants relative to the number of community resources to which they were referred by NSRCH (social navigator) vs. standard care (social worker).

To compare the rate of attendance to NSRCH (social navigator) vs. standard care (social worker) visits.

+2 more

Other outcome measures

Change in Social Determinants of Health (SDH) Screening Status

To compare NSRCH (social navigator) vs. standard care (social worker) with respect to changes in glycemic control.

To compare the resource cost of the social navigator compared to the social worker.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

Participants in the intervention group will be referred to a social navigator to address their identified social needs.

Group II: Control GroupActive Control1 Intervention

Participants in the control group will be referred to a social worker, as per standard care.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of Eastern OntarioLead Sponsor

126 Previous Clinical Trials

55,378 Total Patients Enrolled

Caroline Zuijdwijk, MDPrincipal InvestigatorChildren's Hospital of Eastern Ontario

Media Library

Social Navigator Clinical Trial Eligibility Overview. Trial Name: NCT05900505 — N/A

Type 1 Diabetes Research Study Groups: Intervention Group, Control Group

Type 1 Diabetes Clinical Trial 2023: Social Navigator Highlights & Side Effects. Trial Name: NCT05900505 — N/A

Social Navigator 2023 Treatment Timeline for Medical Study. Trial Name: NCT05900505 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining in this trial for participants?

"The study's presence on clinicaltrials.gov indicates that it is no longer actively seeking patients; the trial was first posted June 1st 2023, and has not been updated since June 9th 2023. However, there are presently 379 other medical studies recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Social Navigator to Address Social Determinants of Health in Pediatrics

Caroline Zuijdwijk 2023. "Social Navigator to Address Social Determinants of Health in Pediatrics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05900505.