Stakeholder EngagementPRECIDENTD-EMSNCT07053046
PRECIDENTD Engagement Methods for Sites
A study testing Standard engagement approach and Agile methods engagement approach in people with Stakeholder Engagement, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This trial is evaluating approaches to effective stakeholder engagement as part of an ongoing multi-site trial, called PRECIDENTD (PREvention of Cardiovascular and DiabEtic kidNey disease in Type 2 Diabetes). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stakeholder Engagement
- What is being tested?
- Standard engagement approach and Agile methods engagement approach
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to 31 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PRECIDENTD patient stakeholder advisory council partners
- PRECIDENTD site study staff
- PRECIDENTD site investigators
Who cannot join
None listed.
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
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
Official title: PRECIDENTD Engagement Methods for Sites (PRECIDENTD-EMS)
This trial is evaluating approaches to effective stakeholder engagement as part of an ongoing multi-site trial, called PRECIDENTD (PREvention of Cardiovascular and DiabEtic kidNey disease in Type 2 Diabetes). PRECIDENTD is a PCORI-funded trial comparing two classes of medication for reducing major health events (e.g., heart attack, stroke, kidney disease) in patients with type 2 diabetes. This is a trial within PRECIDENTD examining Engagement Methods for Sites (PRECIDENTD-EMS) in which PRECIDENTD study sites are randomized to agile engagement methods or a standard engagement approach. The application of agile methods will provide opportunities for increased collaboration between patient partners and study sites during the conduct of the study. The hypothesis is that this will result in better research outcomes for the larger PRECIDENTD study, as well as engagement quality and partner outcomes among those engaged with the conduct of the PRECIDENTD study, as compared with a standard engagement approach.
This study is designed to assess if agile methodology - when applied to engagement during the conduct of a study - will affect research outcomes of that study, as well as the quality of engagement.
Read more
Aim 1: Evaluate whether agile methods applied to stakeholder engagement impact research outcomes. The investigators will compare research outcomes (recruitment, adherence to assigned medication, and retention in the larger PRECIDENTD study) between study sites in the agile and standard engagement arms.
Aim 2. Evaluate whether agile methods in stakeholder engagement impact partners and identify potential mediators of effects. The investigators will examine engagement quality and partner outcomes between the agile and standard engagement arms. The investigators will also explore engagement quality as a potential driver/mediator of the effects of agile methods on partner outcomes.
- Conditions
- Stakeholder Engagement
- Being tested
- Standard engagement approach, Agile methods engagement approach
- Keywords
- Stakeholders, Engagement, Agile Methods, Patient Partners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard engagement approachOther
Large group meetings led by PRECIDENTD PIs; composed of ~20 sites (with ~25 site investigators and ~40 study staff). PRECIDENTD PIs will share updates and facilitate discussion around any problems.
Problem identification and steps toward solution occur sequentially. A problem is identified in the data (e.g., slow recruitment), then brought to the Stakeholder Advisory Council (SAC) for advisement, then back to site investigators and study staff to implement recommended changes, the PIs look at data to see if changes improved the problem. PIs and the Stakeholder Engagement Core broker information and relationships with SAC partners.
Agile methods engagement approachOther
Small group meetings led by a coordinator trained in agile methods; composed of ~4 sites each (representing 4-6 investigators and 6-10 study staff), plus 2-3 Stakeholder Advisory Council (SAC) patient partners. Meetings will focus on problem-solving around specific topics and apply agile tools and principles.
Sites in each small group will review process data together and each site will identify a specific topic (recruitment, retention, medication adherence) to focus on improving over the next month. Research partners at sites and patient partners will contribute to discussion and reflection on barriers, challenges, successes, and facilitators. Steps toward solutions occur on a rapid timeframe, iteratively using data as a guidepost.
| Study group | Role | What they receive |
|---|---|---|
| Standard engagement approach | Placebo comparator | Not described Receives: Other: Standard engagement approach |
| Agile methods engagement approach | Experimental | Not described Receives: Other: Agile methods engagement approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Recruitment
Total patient participants enrolled in PRECIDENTD across sites
Measured: 18 months post-baseline
Engagement experience
As measured by the Patient Engagement in Research Scale (PEIRS); Procedural requirements and Convenience subscales. Items scored on a scale from 0-5, where higher scores indicate better engagement experiences.
Measured: Baseline and 6, 12, and 18 months post-baseline
Partnership functioning
As measured by the Patient Engagement in Research Scale (PEIRS); Contributions and Support subscales. Items scored on a scale from 0-5, where higher scores indicate better partnership functioning.
Measured: Baseline and 6, 12, and 18 months post-baseline
Group dynamics
As measured by the Patient Engagement in Research Scale (PEIRS); Team environment and interaction subscale. Items scored on a scale from 0-5, where higher scores indicate better group dynamics.
Measured: Baseline and 6, 12, and 18 months post-baseline
Equity and Inclusiveness
Selected \& adapted items from the Research Engagement Survey Tool (REST) - Facilitate collaborative, equitable partnerships subscale. Items scored on a scale from 0-5, where higher scores indicate better equity and inclusiveness.
Measured: Baseline and 6, 12, and 18 months post-baseline
Secondary outcomes (6)
Medication adherence
Proportion of PRECIDENTD study participants taking assigned study medication across sites. As assessed by participant self-report via communication with study sites and study assessments.
Measured: Baseline and 18 months
Participant retention
Proportion of PRECIDENTD study participants completing study visits across sites.
Measured: Baseline and 18 months
Participant retention
Proportion of PRECIDENTD study participants completing study assessments across sites.
Measured: Baseline and 18 months
Post-engagement capacity and readiness
Item developed by the study team. Items scored on a scale from 0-5, where higher scores indicate better post-engagement capacity and readiness.
Measured: 12 and 18 months post-baseline
Costs and benefits
Selected \& adapted items from the Patient Engagement in Research Scale (PEIRS); Benefits subscale. Items scored on a scale from 0-5, where higher scores indicate better benefits.
Measured: Baseline and 6, 12, and 18 months post-baseline
Engagement Sustainability
Selected \& adapted items from the REST - Partnership sustainability to meet goals and objectives. Items scored on a scale from 0-5, where higher scores indicate better engagement sustainability.
Measured: 12 and 18 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start7 Jul 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 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 Vanderbilt University Medical CenterThe 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
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Brigham and Women's Hospital
- Responsible party
- Principal investigator, Lyndsay Nelson, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053046
- Sponsor's protocol ID
- 250764
- Other IDs
- SOE-2024C1-37523
- Acronym
- PRECIDENTD-EMS
- Status last verified
- Aug 2026
- First submitted
- 30 Jun 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators plan to share IPD data, but have not yet developed a specific plan.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRECIDENTD Engagement Methods for Sites (PRECIDENTD-EMS)
- ClinicalTrials.gov ID
- NCT07053046
- Acronym / sponsor ID
- PRECIDENTD-EMS / 250764
- Conditions
- Stakeholder Engagement
- Keywords
- Stakeholders, Engagement, Agile Methods, Patient Partners
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Brigham and Women's Hospital
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 8 Jul 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.
This trial is evaluating approaches to effective stakeholder engagement as part of an ongoing multi-site trial, called PRECIDENTD (PREvention of Cardiovascular and DiabEtic kidNey disease in Type 2 Diabetes). PRECIDENTD is a PCORI-funded trial comparing two classes of medication for reducing major health events (e.g., heart attack, stroke, kidney disease) in patients with type 2 diabetes. This is a trial within PRECIDENTD examining Engagement Methods for Sites (PRECIDENTD-EMS) in which PRECIDENTD study sites are randomized to agile engagement methods or a standard engagement approach. The application of agile methods will provide opportunities for increased collaboration between patient partners and study sites during the conduct of the study. The hypothesis is that this will result in better research outcomes for the larger PRECIDENTD study, as well as engagement quality and partner outcomes among those engaged with the conduct of the PRECIDENTD study, as compared with a standard engagement approach.
This study is designed to assess if agile methodology - when applied to engagement during the conduct of a study - will affect research outcomes of that study, as well as the quality of engagement.
Aim 1: Evaluate whether agile methods applied to stakeholder engagement impact research outcomes. The investigators will compare research outcomes (recruitment, adherence to assigned medication, and retention in the larger PRECIDENTD study) between study sites in the agile and standard engagement arms.
Aim 2. Evaluate whether agile methods in stakeholder engagement impact partners and identify potential mediators of effects. The investigators will examine engagement quality and partner outcomes between the agile and standard engagement arms. The investigators will also explore engagement quality as a potential driver/mediator of the effects of agile methods on partner outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard engagement approach | Placebo comparator | Other: Standard engagement approach |
| Agile methods engagement approach | Experimental | Other: Agile methods engagement approach |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- PRECIDENTD patient stakeholder advisory council partners
- PRECIDENTD site study staff
- PRECIDENTD site investigators
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Standard engagement approachLarge group meetings led by PRECIDENTD PIs; composed of ~20 sites (with ~25 site investigators and ~40 study staff). PRECIDENTD PIs will share updates and facilitate discussion around any problems. Problem identification and steps toward solution occur sequentially. A problem is identified in the data (e.g., slow recruitment), then brought to the Stakeholder Advisory Council (SAC) for advisement, then back to site investigators and study staff to implement recommended changes, the PIs look at data to see if changes improved the problem. PIs and the Stakeholder Engagement Core broker information and relationships with SAC partners. | Other | Standard engagement approach |
| Agile methods engagement approachSmall group meetings led by a coordinator trained in agile methods; composed of ~4 sites each (representing 4-6 investigators and 6-10 study staff), plus 2-3 Stakeholder Advisory Council (SAC) patient partners. Meetings will focus on problem-solving around specific topics and apply agile tools and principles. Sites in each small group will review process data together and each site will identify a specific topic (recruitment, retention, medication adherence) to focus on improving over the next month. Research partners at sites and patient partners will contribute to discussion and reflection on barriers, challenges, successes, and facilitators. Steps toward solutions occur on a rapid timeframe, iteratively using data as a guidepost. | Other | Agile methods engagement approach |
Primary outcome
Participant Recruitment
Time frame: 18 months post-baseline
Total patient participants enrolled in PRECIDENTD across sites
Engagement experience
Time frame: Baseline and 6, 12, and 18 months post-baseline
As measured by the Patient Engagement in Research Scale (PEIRS); Procedural requirements and Convenience subscales. Items scored on a scale from 0-5, where higher scores indicate better engagement experiences.
Partnership functioning
Time frame: Baseline and 6, 12, and 18 months post-baseline
As measured by the Patient Engagement in Research Scale (PEIRS); Contributions and Support subscales. Items scored on a scale from 0-5, where higher scores indicate better partnership functioning.
Group dynamics
Time frame: Baseline and 6, 12, and 18 months post-baseline
As measured by the Patient Engagement in Research Scale (PEIRS); Team environment and interaction subscale. Items scored on a scale from 0-5, where higher scores indicate better group dynamics.
Equity and Inclusiveness
Time frame: Baseline and 6, 12, and 18 months post-baseline
Selected \& adapted items from the Research Engagement Survey Tool (REST) - Facilitate collaborative, equitable partnerships subscale. Items scored on a scale from 0-5, where higher scores indicate better equity and inclusiveness.
6 secondary outcomes
Medication adherence
Time frame: Baseline and 18 months
Participant retention
Time frame: Baseline and 18 months
Participant retention
Time frame: Baseline and 18 months
Post-engagement capacity and readiness
Time frame: 12 and 18 months post-baseline
Costs and benefits
Time frame: Baseline and 6, 12, and 18 months post-baseline
Engagement Sustainability
Time frame: 12 and 18 months post-baseline
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 11 Aug 2026.
- Individual participant dataSharing planned: Undecided. The investigators plan to share IPD data, but have not yet developed a specific plan.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard engagement approach and Agile methods engagement approach in people with Stakeholder Engagement, run by Vanderbilt University Medical Center 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 3 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 11 Aug 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. Some participants in this study may receive a placebo. 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?
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?
Participant Recruitment (time frame: 18 months post-baseline). The study lists 5 primary outcomes in all. 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 11 Aug 2026.