Type 1 DiabetesNCT05900505
Social Navigator to Address Social Determinants of Health in Pediatrics
A study testing Social Navigator in people with Type 1 Diabetes, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
It is crucial to understand the social and economic context in which children and youth live; their social determinants of health (SDH). Although this is well recognized, many health care providers do not address SDH because of the lack of easily accessible resources once social needs are identified. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Social Navigator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jun 2023to Dec 2024
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Phase 1
- Parent or guardian of a child, aged between 0-17 years
- Parent or guardian of a patient in the T1D or T2D clinics at CHEO
- Phase 2
- Parent or guardian of a child, aged between 0-17 years
- Parent or guardian of a patient in the T1D or T2D clinics at CHEO
- At least 1 positive response on the SDH Phase 1 Screening Tool
- Optional: child consented to allow access to medical information via electronic medical chart
Who cannot join
- Active social work client at the time of administration of the Phase 1 Screening Tool, defined as families who have had active follow up with a diabetes SW within the last 3 months, with plans for ongoing follow up.
- Unable or unwilling to provide i) implied consent for the completion of the SDH Phase 1 Screening Tool and/or ii) written informed consent for participation in the Phase 2 randomized trial
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Children's Hospital of Eastern Ontario - Research Institute
Ottawa, Ontario, K1H 8L1
Elias Abou-Assaly, BA, 613-737-7600 ext. 6940, eabouassaly@cheo.on.ca
Saunya Dover, MSc, 613-737-7600 ext. 4874, sdover@cheo.on.ca
About this study
Official title: Addressing Child and Family Social Determinants of Health Needs With Social Navigation: Navigating Social Resources for Children's Health "NSRCH" Clinic
It is crucial to understand the social and economic context in which children and youth live; their social determinants of health (SDH). Although this is well recognized, many health care providers do not address SDH because of the lack of easily accessible resources once social needs are identified.
Social workers (SW) have the ability to support families once a social need has been identified. However, not every clinic has a SW, and even those that do often struggle to meet the needs of all the families requiring support.
The use of social navigators (SN) is an innovative solution for an unmet need. SN models have been successful in primary care settings, but, to date, have not been adapted to address the SDH needs of children and their families receiving care in pediatric specialty care settings. We will implement the first of its kind pediatric SN clinic at the Children's Hospital of Eastern Ontario (CHEO): "Navigating Social Resources for Children's Health" (NSRCH). Our study will evaluate NSRCH - an innovative, transferable, and low-cost pediatric-specific SN model. Our goal is to support families with SDH needs to access timely, appropriate supports and resources via NSRCH.
Read the detailed description
In Phase 1 of our study, potential patient-participants will be identified from the type 1 diabetes and type 2 diabetes clinics at CHEO in the following way: the study coordinator will manually screen upcoming patients in the diabetes clinic schedules in Epic. Then, a cover letter and study information sheet will be sent to potential patient-participants (or they would be approached by a study coordinator in-person during the clinic visit). They will follow up with the family to explain the study, answer any questions, confirm interest. Interested families will be asked to complete the Phase 1 Screening Tool.
The study coordinator will be automatically notified of all positive screens (at least 1 identified social need), and then contact the respective families to invite them to participate in Phase 2 of the study and obtain informed consent.
At baseline, the coordinator will collect baseline data and have the families complete the Quality of Life - Brief Version (WHOQOL-BREF) and Baseline Questionnaire. After the visit, participants will be randomized to the intervention or control groups using the randomization module in REDCap. A referral will then be forwarded to either the SN or SW. All clinic visits between baseline and follow up will be scheduled directly by the SN or SW. The SN and the SW will be asked to complete a checklist for each participant consultation, and the results will be summarized by the coordinator.
Participants will be contacted by a coordinator for a follow up visit at 6 months. At which time, they will collect follow-up data and have the families complete the Phase 1 Screening Tool, WHOQOL-BREF, and CSQ.
- Conditions
- Type 1 Diabetes
- Being tested
- Social Navigator
- 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.
Social NavigatorOther
The social navigator will assess patient/family needs and help them to access community resources (specific to their community) to address these, while promoting their engagement and self-efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group will be referred to a social navigator to address their identified social needs. Receives: Other: Social Navigator |
| Control Group | No intervention | Participants in the control group will be referred to a social worker, as per standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare participant satisfaction with NSRCH (social navigator) vs. standard care (social worker), as measured by the Client Satisfaction Questionnaire (CSQ).
Client Satisfaction Questionnaire: Participant satisfaction will be determined using a validated Client Satisfaction Questionnaire (CSQ). The CSQ is scored on a scale of 8 to 32, with higher scores indicating higher satisfaction.
Measured: 6 months
Secondary outcomes (5)
To compare the time to access NSRCH (social navigator) vs. standard care (social worker).
Measured: 6 months
To compare the rate of attendance to NSRCH (social navigator) vs. standard care (social worker) visits.
Measured: 6 months
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).
Measured: 6 months
To compare whether resources provided to the participants corresponded to their identified social needs at NSRCH (social navigator) vs. standard care (social worker).
The social workers and social navigator will be required to indicate which resources were referred to each participant. They will also be required to indicate if the resource corresponds to one or more of the participant's identified social need(s). The mean percentage of resources that correspond to identified social needs will be compared between NSRCH (social navigator) and standard care (social workers).
Measured: 6 months
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.
Quality of Life: change in quality of life from baseline to end of study (pre/post intervention) will be compared between the NSRCH and standard care groups. Quality of life will be assessed using the World Health Organization Quality of Life - Brief Version (WHOQOL-BREF). The WHOQOL-BREF is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. Higher scores denote a higher quality of life. This measure provides 4 domain scores, one for each domain in which quality of life is assessed: physical (raw score 7-35), psychological (raw score 6-30), social relationships (raw score 3-15), and environment (raw score 8-40). Raw scores can also be transformed to reflect scores of 4-20 or 0-100.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start26 Jun 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Zuijdwijk, Children's Hospital of Eastern Ontario
- Investigators
- Caroline Zuijdwijk, MD, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900505
- Sponsor's protocol ID
- 22/65X
- Status last verified
- Mar 2024
- First submitted
- 19 Apr 2023
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Child and Family Social Determinants of Health Needs With Social Navigation: Navigating Social Resources for Children's Health "NSRCH" Clinic
- ClinicalTrials.gov ID
- NCT05900505
- Acronym / sponsor ID
- 22/65X
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Jun 2023 (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.
It is crucial to understand the social and economic context in which children and youth live; their social determinants of health (SDH). Although this is well recognized, many health care providers do not address SDH because of the lack of easily accessible resources once social needs are identified.
Social workers (SW) have the ability to support families once a social need has been identified. However, not every clinic has a SW, and even those that do often struggle to meet the needs of all the families requiring support.
The use of social navigators (SN) is an innovative solution for an unmet need. SN models have been successful in primary care settings, but, to date, have not been adapted to address the SDH needs of children and their families receiving care in pediatric specialty care settings. We will implement the first of its kind pediatric SN clinic at the Children's Hospital of Eastern Ontario (CHEO): "Navigating Social Resources for Children's Health" (NSRCH). Our study will evaluate NSRCH - an innovative, transferable, and low-cost pediatric-specific SN model. Our goal is to support families with SDH needs to access timely, appropriate supports and resources via NSRCH.
Detailed description
In Phase 1 of our study, potential patient-participants will be identified from the type 1 diabetes and type 2 diabetes clinics at CHEO in the following way: the study coordinator will manually screen upcoming patients in the diabetes clinic schedules in Epic. Then, a cover letter and study information sheet will be sent to potential patient-participants (or they would be approached by a study coordinator in-person during the clinic visit). They will follow up with the family to explain the study, answer any questions, confirm interest. Interested families will be asked to complete the Phase 1 Screening Tool.
The study coordinator will be automatically notified of all positive screens (at least 1 identified social need), and then contact the respective families to invite them to participate in Phase 2 of the study and obtain informed consent.
At baseline, the coordinator will collect baseline data and have the families complete the Quality of Life - Brief Version (WHOQOL-BREF) and Baseline Questionnaire. After the visit, participants will be randomized to the intervention or control groups using the randomization module in REDCap. A referral will then be forwarded to either the SN or SW. All clinic visits between baseline and follow up will be scheduled directly by the SN or SW. The SN and the SW will be asked to complete a checklist for each participant consultation, and the results will be summarized by the coordinator.
Participants will be contacted by a coordinator for a follow up visit at 6 months. At which time, they will collect follow-up data and have the families complete the Phase 1 Screening Tool, WHOQOL-BREF, and CSQ.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Social NavigatorParticipants in the intervention group will be referred to a social navigator to address their identified social needs. |
| Control Group | No intervention | –Participants in the control group will be referred to a social worker, as per standard care. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Phase 1
- Parent or guardian of a child, aged between 0-17 years
- Parent or guardian of a patient in the T1D or T2D clinics at CHEO
- Phase 2
- Parent or guardian of a child, aged between 0-17 years
Key exclusion criteria (2 listed)
- Active social work client at the time of administration of the Phase 1 Screening Tool, defined as families who have had active follow up with a diabetes SW within the last 3 months, with plans for ongoing follow up.
- Unable or unwilling to provide i) implied consent for the completion of the SDH Phase 1 Screening Tool and/or ii) written informed consent for participation in the Phase 2 randomized trial
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 |
|---|---|---|
| Social NavigatorThe social navigator will assess patient/family needs and help them to access community resources (specific to their community) to address these, while promoting their engagement and self-efficacy. | Other | Intervention Group |
Primary outcome
To compare participant satisfaction with NSRCH (social navigator) vs. standard care (social worker), as measured by the Client Satisfaction Questionnaire (CSQ).
Time frame: 6 months
Client Satisfaction Questionnaire: Participant satisfaction will be determined using a validated Client Satisfaction Questionnaire (CSQ). The CSQ is scored on a scale of 8 to 32, with higher scores indicating higher satisfaction.
5 secondary outcomes
To compare the time to access NSRCH (social navigator) vs. standard care (social worker).
Time frame: 6 months
To compare the rate of attendance to NSRCH (social navigator) vs. standard care (social worker) visits.
Time frame: 6 months
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).
Time frame: 6 months
To compare whether resources provided to the participants corresponded to their identified social needs at NSRCH (social navigator) vs. standard care (social worker).
Time frame: 6 months
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.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes
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.
Caroline Zuijdwijk, 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 Social Navigator in people with Type 1 Diabetes, run by Children's Hospital of Eastern Ontario 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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elias Abou-Assaly, BA (613-737-7600 ext. 6940, eabouassaly@cheo.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare participant satisfaction with NSRCH (social navigator) vs. standard care (social worker), as measured by the Client Satisfaction Questionnaire (CSQ). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2024.