Stakeholder EngagementNCT07166913
Enhancing Engagement of Partners in Research
A study testing Toolkit in people with Stakeholder Engagement, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to examine the implementation and effectiveness of a bundle of engagement strategies for pediatric patient centered outcomes research (PCOR) studies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stakeholder Engagement
- What is being tested?
- Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, PIs must oversee a study that meets the following criteria:
- Studies who either have not started enrollment or are within 1-3 months of the start of enrollment, and within the 25% ceiling for % recruitment target.
- Studies that have started enrollment must be no further than 25% of projected enrollment timeline of the study (with at least 6 months remaining for enrollment).
- Target n>50 participants in study.
- At least 10 stakeholder partners part of study. The PI's must also be ≥18 years old;
- In order for study stakeholders to be eligible to participate in this study, an individual must meet all of the following criteria:
Show all 10Show fewer
- >=12 years old;
- Ability to speak either English, Spanish, or Chinese, and;
- Part of the study team or serving in an advisory capacity to the study team
- The same criteria as that used for stakeholder and PI eligibility applies to Key informant (KI) interviews.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Not able to complete 6 month follow-up assessment
- Children who are wards/foster children
- Not able or willing to provide consent.
- Concurrent enrollment in another study that is part of this research project.
- In addition, PI's who meet the following criteria will be excluded from participation in this study:
- 1. A lot of experience with stakeholder engagement (based on screener survey question)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Enhancing Stakeholder Engagement in Pediatric Research
The purpose of this study is to examine the implementation and effectiveness of a bundle of engagement strategies for pediatric patient centered outcomes research (PCOR) studies. The study aims to examine the effectiveness of a "bundle" of enhanced engagement strategies on improved stakeholder engagement and study protocol indicators (including improved language access, meeting recruitment/retention goals) compared to standard practice.
- Conditions
- Stakeholder Engagement
- Being tested
- Toolkit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToolkitBehavioural
The toolkit contains information regarding enhanced stakeholder engagement strategies. The toolkit includes guidance materials, checklists, and templates/ sample materials, to increase stakeholder engagement in the research. This includes guidance on setting up a stakeholder advisory board (SAB) and ensuring literacy- and language- sensitivity of participant-/stakeholder-facing materials.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Strategies | Experimental | Subjects assigned to the Enhanced Strategies arm will receive a toolkit of enhanced stakeholder engagement strategies. Receives: Behavioral: Toolkit |
| Standard Practice | No intervention | No Intervention. Participants will continue to implement standard practices used by investigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Research Engagement Survey Tool (REST) stakeholder engagement score
This tool consists of 32 items and assesses engagement across 8 domains, using a 5-point Likert scale for each item. The 8 domains include: 1) focus on community perspectives and determinants of health, 2) partner input, 3) partnership sustainability, 4) fostering co-learning, capacity building and co-benefit, 5) building on strengths and resources, 6) facilitating collaborative, equitable partnerships, 7) involving partners in the dissemination process, and 8) building and maintaining trust. Engagement principle (EP) scores are calculated as an average of non-missing items. The 8 means are used to calculate the overall stakeholder engagement score. Higher scores indicate higher degree of stakeholder engagement.
Measured: Month 6
Secondary outcomes (3)
Patient Engagement in Research Scale (PEIRS) stakeholder engagement score
The scale consists of 22 items and assesses engagement across seven domains, using a 5-point Likert scale for each item. The 7 domains include: 1) procedural requirements, 2) convenience, 3) contributions, 4) team environment and interaction, 5) support, 6) feel valued, and 7) benefits. The total score is calculated by summing the scores for each item and dividing by the maximum possible score. This result is then multiplied by 100 to get a score out of 100. Higher scores indicate a greater degree of meaningful patient engagement.
Measured: Month 6
Reading grade level of written materials
Mean of 5 readability formulas (Flesch Reading Ease, Flesch-Kincaid, Simple Measure of Gobbledygook (SMOG), Gunning Fog, Forcast). Lower score reflects lower reading grade level.
Measured: Month 6
Patient Education Materials Assessment Tool (PEMAT) score
Consists of Understandability (19 items) and Actionability (7 items) subscales. Scoring is as follows: (Total points / possible points yields) x100 = Score %. Higher score reflects greater understandability / actionability.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start8 Sep 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stakeholder EngagementStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- H. Shonna Yin, MD, MS, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166913
- Sponsor's protocol ID
- 24-01851
- Other IDs
- SOE-2022C2-28894
- Status last verified
- Jul 2026
- First submitted
- 9 Sep 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Hsiang.Yin@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Stakeholder Engagement in Pediatric Research
- ClinicalTrials.gov ID
- NCT07166913
- Acronym / sponsor ID
- 24-01851
- Conditions
- Stakeholder Engagement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 11 Sep 2025 (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.
The purpose of this study is to examine the implementation and effectiveness of a bundle of engagement strategies for pediatric patient centered outcomes research (PCOR) studies. The study aims to examine the effectiveness of a "bundle" of enhanced engagement strategies on improved stakeholder engagement and study protocol indicators (including improved language access, meeting recruitment/retention goals) compared to standard practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Strategies | Experimental | Behavioral: ToolkitSubjects assigned to the Enhanced Strategies arm will receive a toolkit of enhanced stakeholder engagement strategies. |
| Standard Practice | No intervention | –No Intervention. Participants will continue to implement standard practices used by investigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- In order to be eligible to participate in this study, PIs must oversee a study that meets the following criteria:
- Studies who either have not started enrollment or are within 1-3 months of the start of enrollment, and within the 25% ceiling for % recruitment target.
- Studies that have started enrollment must be no further than 25% of projected enrollment timeline of the study (with at least 6 months remaining for enrollment).
- Target n>50 participants in study.
- At least 10 stakeholder partners part of study. The PI's must also be ≥18 years old;
Key exclusion criteria (7 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Not able to complete 6 month follow-up assessment
- Children who are wards/foster children
- Not able or willing to provide consent.
- Concurrent enrollment in another study that is part of this research project.
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 |
|---|---|---|
| ToolkitThe toolkit contains information regarding enhanced stakeholder engagement strategies. The toolkit includes guidance materials, checklists, and templates/ sample materials, to increase stakeholder engagement in the research. This includes guidance on setting up a stakeholder advisory board (SAB) and ensuring literacy- and language- sensitivity of participant-/stakeholder-facing materials. | Behavioural | Enhanced Strategies |
Primary outcome
Research Engagement Survey Tool (REST) stakeholder engagement score
Time frame: Month 6
This tool consists of 32 items and assesses engagement across 8 domains, using a 5-point Likert scale for each item. The 8 domains include: 1) focus on community perspectives and determinants of health, 2) partner input, 3) partnership sustainability, 4) fostering co-learning, capacity building and co-benefit, 5) building on strengths and resources, 6) facilitating collaborative, equitable partnerships, 7) involving partners in the dissemination process, and 8) building and maintaining trust. Engagement principle (EP) scores are calculated as an average of non-missing items. The 8 means are used to calculate the overall stakeholder engagement score. Higher scores indicate higher degree of stakeholder engagement.
3 secondary outcomes
Patient Engagement in Research Scale (PEIRS) stakeholder engagement score
Time frame: Month 6
Reading grade level of written materials
Time frame: Month 6
Patient Education Materials Assessment Tool (PEMAT) score
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Hsiang.Yin@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Related trials for Stakeholder Engagement
Enrolling by invitation
PRECIDENTD Engagement Methods for Sites
Stakeholder Engagement
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.
H. Shonna Yin, MD, MS principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toolkit in people with Stakeholder Engagement, run by NYU Langone Health at 1 site in United States.
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 10 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact H. Shonna Yin, MD, MS (646-501-4284, Hsiang.Yin@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Research Engagement Survey Tool (REST) stakeholder engagement score (time frame: Month 6). 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 31 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.