Workplace CulturePOLNCT05499468
Evaluating a Physician Opinion Leader Intervention to Increase Utilization of Coaching/Therapy During Residency
A study testing Popular-Opinion Leader-led encouragement during training meetings and informal conversation in people with Workplace Culture and Help-Seeking Behavior, run by Stanford University at 1 site in United States.
Trial summary
Investigators will assess the efficacy of a physician popular opinion leader-led intervention to increase awareness and utilization of existing evidence-based coaching or therapy among post-graduate clinical trainees at Stanford. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Workplace Culture, Help-Seeking Behavior, Social Stigma
- What is being tested?
- Popular-Opinion Leader-led encouragement during training meetings and informal conversation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 493 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2022to 11 Oct 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- This post-test only evaluation study will use de-identified data that investigators will request after administrative survey data is collected by the organization
- The primary aim dataset will include WellConnect program level usage data, indicating the total aggregate number of service requests from the cohorts of physicians in the 20 postgraduate training programs at Stanford whose program directors opted to allow their trainees to participate in the Popular Opinion Leader-led population health promotion intervention
- The data set for secondary aims will include completely de-identified data from all house-staff who are enrolled in programs participating in the POL program, and who completed the regularly scheduled institutional wellness survey
Who cannot join
- Nonphysicians
- Those outside 20 training programs cohorts participating in the POL intervention at Stanford
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating a Physician Popular Opinion Leader-Led Intervention to Encourage Postgraduate Trainee Participation in One-On-One Support Resources
Investigators will assess the efficacy of a physician popular opinion leader-led intervention to increase awareness and utilization of existing evidence-based coaching or therapy among post-graduate clinical trainees at Stanford.
Read the detailed description
All Stanford residents are provided access to evidence-based coaching and/or therapy, such as cognitive and behavioral targeting of drivers of burnout.
The present project evaluates the ability of a popular opinion leader approach to normalize use of these resources with the hope of increasing utilization. Over the ark of 31 months, all training programs will receive the intervention.
A flexible, minimally intrusive, residency-randomized cluster design will be used to determine the sequence of which programs receive the intervention immediately verses delayed. Investigators delivered an intervention adapted from the CDC Popular Opinion Leader framework for encouraging physicians to utilize existing resources for individual support during residency through Stanford WellConnect (a confidential mental health promotion program for medical residents, fellows, and all benefits-eligible faculty in the School of Medicine at Stanford during their training). Support resources include evidence-based coaching and/or therapy, such as cognitive and behavioral targeting of drivers of burnout for which physicians are at higher-than-average risk. All health promotion efforts were delivered as part of clinical training, outside the scope of this distinct research evaluation. No data has been collected from individual POLs or workshop participants to date.
Investigators will utilize administratively collected data from postgraduate physician trainee populations across 20 Stanford paired residency programs with 5 or more house-staff (residents or fellows) each. 10 programs were randomly assigned to be the first to receive the intervention, and 10 to a delayed intervention group (10 programs). The immediate intervention arm (vs. delayed) received a POL-led health promotion intervention delivered as part of their regular postgraduate medical training educational activities (e.g., during didactic sessions), designed to encourage them to consider participating in existing, evidence-based one-on-one support resources (coaching and therapy with trained professionals) available through WellConnect. The POL intervention includes two formal workshop discussions and informal conversations with trained physician POL colleagues. The delayed intervention arm continued to receive their regular postgraduate medical training educational activities as well as access to the same coaching and therapy resources through WellConnect, and any other wellness resources involved in the curriculum at each program as the immediate intervention arm. The delayed intervention arm will also receive the POL program from November 1st 2022 through May 2023.
The investigators will evaluate multiple outcomes between the immediate and delayed intervention arms using administratively collected WellConnect usage data (% of each program who participate in coaching or therapy from each enrolled residency program population during the trial). In addition, investigators will analyze administratively collected institutional wellness survey data to determine population level differences in perceptions of stigma against mental health support, self-valuation, burnout, and professional fulfillment.
- Being tested
- Popular-Opinion Leader-led encouragement during training meetings and informal conversation
- Keywords
- Occupational Culture, Trainee Mental Health, Physician Stigma, Resident Health Promotion
- Medical subject headings
- Help-Seeking Behavior, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Popular-Opinion Leader-led encouragement during training meetings and informal conversationOther
Investigators adapted evidence-based principles from the Popular Opinion Leader framework to increase utilizations of existing one-on-one emotional support resources for physicians-in-training at Stanford (an effective HIV prevention intervention developed by the CDC for changing social norms and reducing behavioral risk factors led by influential members of a community, trained to promote behavior change). All intervention activities designed to encourage utilization were delivered as part of health promotion during pre-existing clinical training meetings and no data was collected during these workshops. Identified POLs were recruited and trained to encourage their colleagues to use existing support resources and engage in two 30-60 minute workshops scheduled to occur during training meetings.
| Study group | Role | What they receive |
|---|---|---|
| Popular-Opinion Leader-led workshops & conversations to encourage utilization of support resources | Other | Physicians identified by programwide Qualtrics survey item asking housestaff who in their program they respect and trust most, personally and professionally. Identified POLs were invited to join this health promotion effort as a POL to improve the culture of wellness and psychological safety among housestaff and encourage them to utilize resources at a time when they may benefit significantly. POLs were trained to endorse the benefits of mental health promotion coaching or therapy for residents training at Stanford. Receives: Other: Popular-Opinion Leader-led encouragement during training meetings and informal conversation |
| Standard Training Program Curriculum and Access to Existing Support Resources | No intervention | All residents and fellows continued to have the same access to coaching and psychotherapy resources available through Stanford WellConnect, along with other educational activities in their usual training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants enrolled in WellConnect program
The WellConnect service tracks utilization by residents in each department. The study team will ask WellConnect to report the total number of calls from November 1, 2021, through June 30th 2022, from house-staff (residents and fellows) who are part of training programs that participated in the POL program. The proportion of residents in each program who participate in coaching or psychotherapy support offered by the WellConnect program will be calculated by dividing the number of residents who participate in the program by the total number of residents enrolled in the program.
Measured: study week 7, program usage report will be requested from WellConnect Coordinator in October 2022
Secondary outcomes (4)
Score in "Disclosure and Help-Seeking" Subscale of the Opening Minds Stigma Scale for Health Care Providers (from administratively collected institutional wellness survey data)
"Disclosure and Help-seeking subscale" is a subscale of the Opening Minds Scale for Health Care Providers (OMS-HC) includes 4 items, with responses on a Likert scale (scores range from 1 to 5, where a higher score is less favorable). Respondents are instructed "These questions ask you to agree or disagree with a series of statements about mental illness. There is no correct answer. Please mark the box that best fits your opinion" and statements include: 1) "If I were under treatment for a mental illness I would not disclose this to any of my colleagues"; 2) "I would see myself as weak if I had a mental illness and could not fix it myself"; 3) "I would be reluctant to seek help if I had a mental illness"; and 4) "If I had a mental illness, I would tell my friends."
Measured: study week 7, post-intervention, de-identified data will be requested from organization-wide administratively collected survey data. This data will be requested in December, 2022
Response to standardized question from the National Comorbidity Survey ("Attitudes Regarding Help Seeking" item) from administratively collected institutional wellness survey data
Assessed using a single standardized item from the National Comorbidity Survey, which asks "People differ a lot in their feelings about professional help for emotional problems. If you had a serious emotional problem, would you definitely go for professional help, probably go, probably not go, or definitely not go for professional help?" Responses (ranging from most to least favorable) are: "Would definitely go," "Would probably go," "Would probably not go," and "Would definitely not go." Source: Mojtabai R, Evans-Lacko S, Schomerus G, Thornicroft G. Attitudes Toward Mental Health Help Seeking as Predictors of Future Help-Seeking Behavior and Use of Mental Health Treatments. Psychiatr Serv. 2016 Jun 1;67(6):650-7. doi: 10.1176/appi.ps.201500164. Epub 2016 Feb 14. PMID: 26876662.
Measured: study week 7, post-intervention de-identified data will be requested from organization-wide administratively collected survey data. This data will be requested in December, 2022.
Stanford Professional Fulfillment Index Score (from administratively collected institutional wellness survey data)
Each PFI item is scored from 0 to 4, using the associated five-point Likert scale. Scale scores are then calculated by averaging the items scores of all item within each corresponding scale, such that all scale scores also range from 0 to 4, which are then converted to a scale of 0-10.
Using 0-10 scale, the cut-point for Professional fulfillment is 7.5 and greater (higher score more favorable, and for Overall Burnout is 3.325 and greater (lower score more favorable). Professional fulfillment scale cut-point is 7.5. Those with average scores of 7.5 and greater are more likely to be professionally fulfilled. Overall Burnout, has a cut-point of 3.325. Those with averages scores of 3.325 or greater are more likely to be experiencing Burnout.
Measured: study week 7, post-intervention de-identified data will be requested from organization-wide administratively collected survey. This data will be requested in December, 2022.
Self-Valuation Index Score (from administratively collected institutional wellness survey data)
Self-valuation is a construct "involving constructive prioritization of personal well-being and a growth mindset perspective that seeks to learn and improve as the primary response to errors," assessed using 4-item questionnaire that asks respondents to characterize their experiences in the past 2 weeks, measured using "a 5-point (0-4) Likert scale (summative score range, 0-16, higher score more favorable)," where total self valuation index score is calculated by adding up individual item scores.
Measured: study week 7, post-intervention de-identified data will be requested from organization-wide administratively collected survey data. This data will be requested in December, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start30 Aug 2022
- Primary completion11 Oct 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Workplace CultureStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 493 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians Foundation
- Responsible party
- Principal investigator, Mickey Trockel, Stanford University
- Investigators
- Mickey T Trockel, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499468
- Sponsor's protocol ID
- 60993
- Acronym
- POL
- Status last verified
- Nov 2022
- First submitted
- 10 Aug 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kassam A, Papish A, Modgill G, Patten S. The development and psychometric properties of a new scale to measure mental illness related stigma by health care providers: the Opening Minds Scale for Health Care Providers (OMS-HC). BMC Psychiatry. 2012 Jun 13;12:62. doi: 10.1186/1471-244X-12-62.
PubMed 22694771Trockel M, Bohman B, Lesure E, Hamidi MS, Welle D, Roberts L, Shanafelt T. A Brief Instrument to Assess Both Burnout and Professional Fulfillment in Physicians: Reliability and Validity, Including Correlation with Self-Reported Medical Errors, in a Sample of Resident and Practicing Physicians. Acad Psychiatry. 2018 Feb;42(1):11-24. doi: 10.1007/s40596-017-0849-3. Epub 2017 Dec 1.
PubMed 29196982Trockel MT, Hamidi MS, Menon NK, Rowe SG, Dudley JC, Stewart MT, Geisler CZ, Bohman BD, Shanafelt TD. Self-valuation: Attending to the Most Important Instrument in the Practice of Medicine. Mayo Clin Proc. 2019 Oct;94(10):2022-2031. doi: 10.1016/j.mayocp.2019.04.040. Epub 2019 Sep 19.
PubMed 31543254NIMH Collaborative HIV/STD Prevention Trial Group. The community popular opinion leader HIV prevention programme: conceptual basis and intervention procedures. AIDS. 2007 Apr;21 Suppl 2:S59-68. doi: 10.1097/01.aids.0000266458.49138.fa.
PubMed 17413265Shanafelt TD, Dyrbye LN, West CP, Sinsky C, Tutty M, Carlasare LE, Wang H, Trockel M. Suicidal Ideation and Attitudes Regarding Help Seeking in US Physicians Relative to the US Working Population. Mayo Clin Proc. 2021 Aug;96(8):2067-2080. doi: 10.1016/j.mayocp.2021.01.033. Epub 2021 Jul 20.
PubMed 34301399Mojtabai R, Evans-Lacko S, Schomerus G, Thornicroft G. Attitudes Toward Mental Health Help Seeking as Predictors of Future Help-Seeking Behavior and Use of Mental Health Treatments. Psychiatr Serv. 2016 Jun 1;67(6):650-7. doi: 10.1176/appi.ps.201500164. Epub 2016 Feb 14.
PubMed 26876662
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Physician Popular Opinion Leader-Led Intervention to Encourage Postgraduate Trainee Participation in One-On-One Support Resources
- ClinicalTrials.gov ID
- NCT05499468
- Acronym / sponsor ID
- POL / 60993
- Keywords
- Occupational Culture, Trainee Mental Health, Physician Stigma, Resident Health Promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- The Physicians Foundation
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 11 Oct 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 12 Aug 2022 (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.
Investigators will assess the efficacy of a physician popular opinion leader-led intervention to increase awareness and utilization of existing evidence-based coaching or therapy among post-graduate clinical trainees at Stanford.
Detailed description
All Stanford residents are provided access to evidence-based coaching and/or therapy, such as cognitive and behavioral targeting of drivers of burnout.
The present project evaluates the ability of a popular opinion leader approach to normalize use of these resources with the hope of increasing utilization. Over the ark of 31 months, all training programs will receive the intervention.
A flexible, minimally intrusive, residency-randomized cluster design will be used to determine the sequence of which programs receive the intervention immediately verses delayed. Investigators delivered an intervention adapted from the CDC Popular Opinion Leader framework for encouraging physicians to utilize existing resources for individual support during residency through Stanford WellConnect (a confidential mental health promotion program for medical residents, fellows, and all benefits-eligible faculty in the School of Medicine at Stanford during their training). Support resources include evidence-based coaching and/or therapy, such as cognitive and behavioral targeting of drivers of burnout for which physicians are at higher-than-average risk. All health promotion efforts were delivered as part of clinical training, outside the scope of this distinct research evaluation. No data has been collected from individual POLs or workshop participants to date.
Investigators will utilize administratively collected data from postgraduate physician trainee populations across 20 Stanford paired residency programs with 5 or more house-staff (residents or fellows) each. 10 programs were randomly assigned to be the first to receive the intervention, and 10 to a delayed intervention group (10 programs). The immediate intervention arm (vs. delayed) received a POL-led health promotion intervention delivered as part of their regular postgraduate medical training educational activities (e.g., during didactic sessions), designed to encourage them to consider participating in existing, evidence-based one-on-one support resources (coaching and therapy with trained professionals) available through WellConnect. The POL intervention includes two formal workshop discussions and informal conversations with trained physician POL colleagues. The delayed intervention arm continued to receive their regular postgraduate medical training educational activities as well as access to the same coaching and therapy resources through WellConnect, and any other wellness resources involved in the curriculum at each program as the immediate intervention arm. The delayed intervention arm will also receive the POL program from November 1st 2022 through May 2023.
The investigators will evaluate multiple outcomes between the immediate and delayed intervention arms using administratively collected WellConnect usage data (% of each program who participate in coaching or therapy from each enrolled residency program population during the trial). In addition, investigators will analyze administratively collected institutional wellness survey data to determine population level differences in perceptions of stigma against mental health support, self-valuation, burnout, and professional fulfillment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Popular-Opinion Leader-led workshops & conversations to encourage utilization of support resources | Other | Other: Popular-Opinion Leader-led encouragement during training meetings and informal conversationPhysicians identified by programwide Qualtrics survey item asking housestaff who in their program they respect and trust most, personally and professionally. Identified POLs were invited to join this health promotion effort as a POL to improve the culture of wellness and psychological safety among housestaff and encourage them to utilize resources at a time when they may benefit significantly. POLs were trained to endorse the benefits of mental health promotion coaching or therapy for residents training at Stanford. |
| Standard Training Program Curriculum and Access to Existing Support Resources | No intervention | –All residents and fellows continued to have the same access to coaching and psychotherapy resources available through Stanford WellConnect, along with other educational activities in their usual training. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- This post-test only evaluation study will use de-identified data that investigators will request after administrative survey data is collected by the organization
- The primary aim dataset will include WellConnect program level usage data, indicating the total aggregate number of service requests from the cohorts of physicians in the 20 postgraduate training programs at Stanford whose program directors opted to allow their trainees to participate in the Popular Opinion Leader-led population health promotion intervention
- The data set for secondary aims will include completely de-identified data from all house-staff who are enrolled in programs participating in the POL program, and who completed the regularly scheduled institutional wellness survey
Key exclusion criteria (2 listed)
- Nonphysicians
- Those outside 20 training programs cohorts participating in the POL intervention at Stanford
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 |
|---|---|---|
| Popular-Opinion Leader-led encouragement during training meetings and informal conversationInvestigators adapted evidence-based principles from the Popular Opinion Leader framework to increase utilizations of existing one-on-one emotional support resources for physicians-in-training at Stanford (an effective HIV prevention intervention developed by the CDC for changing social norms and reducing behavioral risk factors led by influential members of a community, trained to promote behavior change). All intervention activities designed to encourage utilization were delivered as part of health promotion during pre-existing clinical training meetings and no data was collected during these workshops. Identified POLs were recruited and trained to encourage their colleagues to use existing support resources and engage in two 30-60 minute workshops scheduled to occur during training meetings. | Other | Popular-Opinion Leader-led workshops & conversations to encourage utilization of support resources |
Primary outcome
Number of participants enrolled in WellConnect program
Time frame: study week 7, program usage report will be requested from WellConnect Coordinator in October 2022
The WellConnect service tracks utilization by residents in each department. The study team will ask WellConnect to report the total number of calls from November 1, 2021, through June 30th 2022, from house-staff (residents and fellows) who are part of training programs that participated in the POL program. The proportion of residents in each program who participate in coaching or psychotherapy support offered by the WellConnect program will be calculated by dividing the number of residents who participate in the program by the total number of residents enrolled in the program.
4 secondary outcomes
Score in "Disclosure and Help-Seeking" Subscale of the Opening Minds Stigma Scale for Health Care Providers (from administratively collected institutional wellness survey data)
Time frame: study week 7, post-intervention, de-identified data will be requested from organization-wide administratively collected survey data. This data will be requested in December, 2022
Response to standardized question from the National Comorbidity Survey ("Attitudes Regarding Help Seeking" item) from administratively collected institutional wellness survey data
Time frame: study week 7, post-intervention de-identified data will be requested from organization-wide administratively collected survey data. This data will be requested in December, 2022.
Stanford Professional Fulfillment Index Score (from administratively collected institutional wellness survey data)
Time frame: study week 7, post-intervention de-identified data will be requested from organization-wide administratively collected survey. This data will be requested in December, 2022.
Self-Valuation Index Score (from administratively collected institutional wellness survey data)
Time frame: study week 7, post-intervention de-identified data will be requested from organization-wide administratively collected survey data. This data will be requested in December, 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Background: PubMed 22694771Kassam A, Papish A, Modgill G, Patten S. The development and psychometric properties of a new scale to measure mental illness related stigma by health care providers: the Opening Minds Scale for Health Care Providers (OMS-HC). BMC Psychiatry. 2012 Jun 13;12:62. doi: 10.1186/1471-244X-12-62.
- Background: PubMed 29196982Trockel M, Bohman B, Lesure E, Hamidi MS, Welle D, Roberts L, Shanafelt T. A Brief Instrument to Assess Both Burnout and Professional Fulfillment in Physicians: Reliability and Validity, Including Correlation with Self-Reported Medical Errors, in a Sample of Resident and Practicing Physicians. Acad Psychiatry. 2018 Feb;42(1):11-24. doi: 10.1007/s40596-017-0849-3. Epub 2017 Dec 1.
- Background: PubMed 31543254Trockel MT, Hamidi MS, Menon NK, Rowe SG, Dudley JC, Stewart MT, Geisler CZ, Bohman BD, Shanafelt TD. Self-valuation: Attending to the Most Important Instrument in the Practice of Medicine. Mayo Clin Proc. 2019 Oct;94(10):2022-2031. doi: 10.1016/j.mayocp.2019.04.040. Epub 2019 Sep 19.
- Background: PubMed 17413265NIMH Collaborative HIV/STD Prevention Trial Group. The community popular opinion leader HIV prevention programme: conceptual basis and intervention procedures. AIDS. 2007 Apr;21 Suppl 2:S59-68. doi: 10.1097/01.aids.0000266458.49138.fa.
- Background: PubMed 34301399Shanafelt TD, Dyrbye LN, West CP, Sinsky C, Tutty M, Carlasare LE, Wang H, Trockel M. Suicidal Ideation and Attitudes Regarding Help Seeking in US Physicians Relative to the US Working Population. Mayo Clin Proc. 2021 Aug;96(8):2067-2080. doi: 10.1016/j.mayocp.2021.01.033. Epub 2021 Jul 20.
- Background: PubMed 26876662Mojtabai R, Evans-Lacko S, Schomerus G, Thornicroft G. Attitudes Toward Mental Health Help Seeking as Predictors of Future Help-Seeking Behavior and Use of Mental Health Treatments. Psychiatr Serv. 2016 Jun 1;67(6):650-7. doi: 10.1176/appi.ps.201500164. Epub 2016 Feb 14.
- Individual participant dataSharing planned: No
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.
Mickey T Trockel, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Popular-Opinion Leader-led encouragement during training meetings and informal conversation in people with Workplace Culture and Help-Seeking Behavior, run by Stanford University 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 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: finished, as of the sponsor's last update on 23 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants enrolled in WellConnect program (time frame: study week 7, program usage report will be requested from WellConnect Coordinator in October 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05499468, which also lists 6 linked publications.
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 23 Nov 2022.