Rheumatic DiseasesNCT04879745

MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases

A study testing MyVoice:Rheum and Pamphlet in people with Rheumatic Diseases and Physician-Patient Relations, run by University of Pittsburgh at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a pilot trial to assess feasibility and acceptability of MyVoice:Rheum vs. a patient pamphlet among female patients ages 18-44 (n=40) who receive rheumatology care. Hypothesis: MyVoice:Rheum will be feasible and acceptable to patients who receive rheumatology care. Read more about this study

Who is it for?: Ages 18 to 44 years, women only
Conditions the study is for: Rheumatic Diseases, Physician-Patient Relations, Contraception
What is being tested?: MyVoice:Rheum and Pamphlet
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 2 sitesUnited States
Study dates: 29 Jul 2021to 1 Mar 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 44 years
Women only
No healthy volunteers
Adult

Who may be able to join

Patients must have at least one of four rheumatic diseases diagnosed by a rheumatologist: rheumatoid arthritis (RA), systemic sclerosis (SSc), myositis, Sjogren's syndrome, vasculitis, spondyloarthritis, and systemic lupus erythematosus (SLE).
Patients must read and speak in English as a Spanish-language version of the tool has not yet been developed
Access to a smart phone, personal computer, or tablet.

Who cannot join

Women who have had prior hysterectomy or sterilization, or are pregnant.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

UPMC Falk Rheumatology Clinic
Pittsburgh, Pennsylvania, 15213
UPMC Lupus Center of Excellence
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: A Pilot Study of the MyVoice:Rheum Decision Aid to Address the Reproductive Health Needs of Women With Rheumatic Diseases

This is a pilot trial to assess feasibility and acceptability of MyVoice:Rheum vs. a patient pamphlet among female patients ages 18-44 (n=40) who receive rheumatology care.

Hypothesis: MyVoice:Rheum will be feasible and acceptable to patients who receive rheumatology care.

Read the detailed description

The pilot will demonstrate if the MyVoice:Rheum decision aid can be feasibly and acceptably implemented into the rheumatology context and inform operational procedures for a future hybrid effectiveness-implementation trial. Women in the intervention arm will receive the MyVoice:Rheum decision aid (n=30). Women in the control arm (n=9) will receive a widely-accessible paper-based pamphlet about pregnancy, which, similarly to MyVoice:Rheum, targets women with a broad range of rheumatic diseases.

Conditions: Rheumatic Diseases, Physician-Patient Relations, Contraception
Being tested: MyVoice:Rheum, Pamphlet
Keywords: rheumatic diseases, shared decision-making, sexual and reproductive health, decision aids
Medical subject headings: Rheumatic Diseases, Coitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MyVoice:RheumOther
Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).
PamphletOther
Participants in this arm will be given a copy of an existing patient pamphlet

Study groups in NCT04879745
Study group	Role	What they receive
Decision Aid Users	Experimental	Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid Receives: Other: MyVoice:Rheum
Pamphlet Users	Active comparator	Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning Receives: Other: Pamphlet

What is being measured

The primary outcome is the main question the study is designed to answer.

Acceptability of Intervention
Acceptability of Intervention Measure (AIM) consist of Four- item measure, Likert scales ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean of scores, with a higher score indicating higher acceptability. We assigned a feasibility threshold of ≥ 3.5 of 5, for which higher scores indicate more positive responses.
Measured: T2 (within 24 hours of intervention and appointment)
Intervention Appropriateness Measure
The validated Intervention Appropriateness Measure (IAM) consist of Four-item Likert scales ranging from 1 (completely disagree) to 5 (completely agree); we assigned a feasibility threshold of ≥ 3.5 of 5 for IAM scores, for which higher scores indicate more positive responses. Score is determined by calculating the mean, with a higher score indicating greater appropriateness.
Measured: T2 (within 24 hours of intervention and appointment)
System Usability Scale
Usability was assessed via summary scores from the System Usability Scale (SUS), which consists of a 10-item Likert scale with scores ranging from 0-100; overall score calculated by finding the mean of items on scale. We set a threshold of scores >80.3 as 'A'/excellent and 68-80.3 as 'B'/very good, consistent with standard rating for the SUS.
Measured: T2 (within 24 hours of intervention and appointment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jul 20211 Mar 2023

First posted10 May 2021
Study start29 Jul 2021
Primary completion31 Dec 2022
Study completion1 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (31)Papers the sponsor has linked to this study.
Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
More trials run by University of PittsburghThe 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: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04879745
Sponsor's protocol ID: STUDY20060240
Other IDs: K23AR075057-01A1
Status last verified: Apr 2024
First submitted: 4 May 2021
Last updated: 30 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Mehta B, Luo Y, Xu J, Sammaritano L, Salmon J, Lockshin M, Goodman S, Ibrahim S. Trends in Maternal and Fetal Outcomes Among Pregnant Women With Systemic Lupus Erythematosus in the United States: A Cross-sectional Analysis. Ann Intern Med. 2019 Aug 6;171(3):164-171. doi: 10.7326/M19-0120. Epub 2019 Jul 9.
PubMed 31284305
Birru Talabi M, Clowse MEB, Schwarz EB, Callegari LS, Moreland L, Borrero S. Family Planning Counseling for Women With Rheumatic Diseases. Arthritis Care Res (Hoboken). 2018 Feb;70(2):169-174. doi: 10.1002/acr.23267. No abstract available.
PubMed 28437837
Rajendran A, Eudy AM, Balevic SJ, Clowse MEB. The importance of pregnancy planning in lupus pregnancies. Lupus. 2021 Apr;30(5):741-751. doi: 10.1177/0961203321989803. Epub 2021 Jan 28.
PubMed 33509066
Birru Talabi M, Callegari LS, Borrero S. Redefining Primum Non Nocere to Include Reproductive Autonomy: A New Paradigm in Subspecialty Medicine. Womens Health Rep (New Rochelle). 2021 Oct 26;2(1):497-499. doi: 10.1089/whr.2021.0079. eCollection 2021.
PubMed 34970654
Birru Talabi M, Eudy AM, Jayasundara M, Haroun T, Nowell WB, Curtis JR, Crow-Hercher R, White CW, Ginsberg S, Clowse MEB. Pregnancy, Periods, and "The Pill": Exploring the Reproductive Experiences of Women with Inflammatory Arthritis. ACR Open Rheumatol. 2019 Apr 15;1(2):125-132. doi: 10.1002/acr2.1016. eCollection 2019 Apr.
PubMed 31777789
Stransky OM, Wolgemuth T, Kazmerski T, Chodoff A, Borrero S, Birru Talabi M. Contraception decision-making and care among reproductive-aged women with autoimmune diseases. Contraception. 2021 Feb;103(2):86-91. doi: 10.1016/j.contraception.2020.11.001. Epub 2020 Nov 9.
PubMed 33181126
Wolgemuth T, Stransky OM, Chodoff A, Kazmerski TM, Clowse MEB, Birru Talabi M. Exploring the Preferences of Women Regarding Sexual and Reproductive Health Care in the Context of Rheumatology: A Qualitative Study. Arthritis Care Res (Hoboken). 2021 Aug;73(8):1194-1200. doi: 10.1002/acr.24249. Epub 2021 Jul 14.
PubMed 32374928
Birru Talabi M, Clowse MEB, Blalock SJ, Hamm M, Borrero S. Perspectives of Adult Rheumatologists Regarding Family Planning Counseling and Care: A Qualitative Study. Arthritis Care Res (Hoboken). 2020 Mar;72(3):452-458. doi: 10.1002/acr.23872.
PubMed 30875455
Frosch DL, Legare F, Fishbein M, Elwyn G. Adjuncts or adversaries to shared decision-making? Applying the Integrative Model of behavior to the role and design of decision support interventions in healthcare interactions. Implement Sci. 2009 Nov 12;4:73. doi: 10.1186/1748-5908-4-73.
PubMed 19909547
Stacey D, Legare F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017 Apr 12;4(4):CD001431. doi: 10.1002/14651858.CD001431.pub5.
PubMed 28402085
O'Connor AM, Llewellyn-Thomas HA, Flood AB. Modifying unwarranted variations in health care: shared decision making using patient decision aids. Health Aff (Millwood). 2004;Suppl Variation:VAR63-72. doi: 10.1377/hlthaff.var.63.
PubMed 15471770
Birru Talabi M, Eudy AM, Jayasundara M, Haroun T, Nowell WB, Curtis JR, Crow-Hercher R, White W, Ginsberg S, Clowse MEB. Tough Choices: Exploring Medication Decision-Making During Pregnancy and Lactation Among Women With Inflammatory Arthritis. ACR Open Rheumatol. 2021 Jul;3(7):475-483. doi: 10.1002/acr2.11240. Epub 2021 Jun 11.
PubMed 34114738
Sammaritano LR, Bermas BL, Chakravarty EE, Chambers C, Clowse MEB, Lockshin MD, Marder W, Guyatt G, Branch DW, Buyon J, Christopher-Stine L, Crow-Hercher R, Cush J, Druzin M, Kavanaugh A, Laskin CA, Plante L, Salmon J, Simard J, Somers EC, Steen V, Tedeschi SK, Vinet E, White CW, Yazdany J, Barbhaiya M, Bettendorf B, Eudy A, Jayatilleke A, Shah AA, Sullivan N, Tarter LL, Birru Talabi M, Turgunbaev M, Turner A, D'Anci KE. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol. 2020 Apr;72(4):529-556. doi: 10.1002/art.41191. Epub 2020 Feb 23.
PubMed 32090480
Krishnamurti T, Birru Talabi M, Callegari LS, Kazmerski TM, Borrero S. A Framework for Femtech: Guiding Principles for Developing Digital Reproductive Health Tools in the United States. J Med Internet Res. 2022 Apr 28;24(4):e36338. doi: 10.2196/36338.
PubMed 35482371
Birru MS, Monaco VM, Charles L, Drew H, Njie V, Bierria T, Detlefsen E, Steinman RA. Internet usage by low-literacy adults seeking health information: an observational analysis. J Med Internet Res. 2004 Sep 3;6(3):e25. doi: 10.2196/jmir.6.3.e25.
PubMed 15471751

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of the MyVoice:Rheum Decision Aid to Address the Reproductive Health Needs of Women With Rheumatic Diseases
ClinicalTrials.gov ID: NCT04879745
Acronym / sponsor ID: STUDY20060240
Conditions: Rheumatic Diseases, Physician-Patient Relations, Contraception
Keywords: rheumatic diseases, shared decision-making, sexual and reproductive health, decision aids
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study start: 29 Jul 2021 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 1 Mar 2023 (actual)
First posted: 10 May 2021 (actual)
Results: Posted 30 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a pilot trial to assess feasibility and acceptability of MyVoice:Rheum vs. a patient pamphlet among female patients ages 18-44 (n=40) who receive rheumatology care.

Hypothesis: MyVoice:Rheum will be feasible and acceptable to patients who receive rheumatology care.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Decision Aid Users	Experimental	Other: MyVoice:RheumPatients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid
Pamphlet Users	Active comparator	Other: PamphletPatients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning

Who may qualify

Ages: 18 to 44 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Patients must have at least one of four rheumatic diseases diagnosed by a rheumatologist: rheumatoid arthritis (RA), systemic sclerosis (SSc), myositis, Sjogren's syndrome, vasculitis, spondyloarthritis, and systemic lupus erythematosus (SLE).
Patients must read and speak in English as a Spanish-language version of the tool has not yet been developed
Access to a smart phone, personal computer, or tablet.

Key exclusion criteria (1 listed)

Women who have had prior hysterectomy or sterilization, or are pregnant.

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
MyVoice:RheumParticipants will be given access to MyVoice:Rheum, a web-based decision aid (DA).	Other	Decision Aid Users
PamphletParticipants in this arm will be given a copy of an existing patient pamphlet	Other	Pamphlet Users

Primary outcome

Acceptability of Intervention
Time frame: T2 (within 24 hours of intervention and appointment)
Acceptability of Intervention Measure (AIM) consist of Four- item measure, Likert scales ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean of scores, with a higher score indicating higher acceptability. We assigned a feasibility threshold of ≥ 3.5 of 5, for which higher scores indicate more positive responses.
Intervention Appropriateness Measure
Time frame: T2 (within 24 hours of intervention and appointment)
The validated Intervention Appropriateness Measure (IAM) consist of Four-item Likert scales ranging from 1 (completely disagree) to 5 (completely agree); we assigned a feasibility threshold of ≥ 3.5 of 5 for IAM scores, for which higher scores indicate more positive responses. Score is determined by calculating the mean, with a higher score indicating greater appropriateness.
System Usability Scale
Time frame: T2 (within 24 hours of intervention and appointment)
Usability was assessed via summary scores from the System Usability Scale (SUS), which consists of a 10-item Likert scale with scores ranging from 0-100; overall score calculated by finding the mean of items on scale. We set a threshold of scores >80.3 as 'A'/excellent and 68-80.3 as 'B'/very good, consistent with standard rating for the SUS.

Results and safety

Results posted to the registry on 30 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Decision Aid Users	35	31
Pamphlet Users	10	9

Primary outcome: Acceptability of Intervention

Time frame: T2 (within 24 hours of intervention and appointment). Mean (Standard Deviation). Unit: score on a scale

Measure	Decision Aid Users n = 30	Pamphlet Users n = 9
Value	4.45 (.59)	3.97 (.65)

Population analysed: 30 of 31 decision aid users completed the AIM.

Primary outcome: Intervention Appropriateness Measure

Time frame: T2 (within 24 hours of intervention and appointment). Mean (Standard Deviation). Unit: score on a scale

Measure	Decision Aid Users n = 30	Pamphlet Users n = 9
Value	4.48 (.61)	4.11 (.85)

Population analysed: 30 of the 31 Decision Aid users completed the IAM.

Primary outcome: System Usability Scale

Time frame: T2 (within 24 hours of intervention and appointment). Mean (Standard Deviation). Unit: score on a scale

Measure	Decision Aid Users n = 30	Pamphlet Users n = 9
Value	83.06 (15.67)	79.32 (14.10)

Population analysed: 30 of the original 31 Decision Aid Users completed the SUS Measure.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Decision Aid Users	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Pamphlet Users	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): Due to an increase in telemedicine utilization over the COVID-19 pandemic, most recruitment was conducted remotely instead of in-person as originally intended. The COVID-19 pandemic coincided with our study, which may account for the low number of participants recruited.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31284305Mehta B, Luo Y, Xu J, Sammaritano L, Salmon J, Lockshin M, Goodman S, Ibrahim S. Trends in Maternal and Fetal Outcomes Among Pregnant Women With Systemic Lupus Erythematosus in the United States: A Cross-sectional Analysis. Ann Intern Med. 2019 Aug 6;171(3):164-171. doi: 10.7326/M19-0120. Epub 2019 Jul 9.
Background: PubMed 28437837Birru Talabi M, Clowse MEB, Schwarz EB, Callegari LS, Moreland L, Borrero S. Family Planning Counseling for Women With Rheumatic Diseases. Arthritis Care Res (Hoboken). 2018 Feb;70(2):169-174. doi: 10.1002/acr.23267. No abstract available.
Background: PubMed 33509066Rajendran A, Eudy AM, Balevic SJ, Clowse MEB. The importance of pregnancy planning in lupus pregnancies. Lupus. 2021 Apr;30(5):741-751. doi: 10.1177/0961203321989803. Epub 2021 Jan 28.
Background: PubMed 34970654Birru Talabi M, Callegari LS, Borrero S. Redefining Primum Non Nocere to Include Reproductive Autonomy: A New Paradigm in Subspecialty Medicine. Womens Health Rep (New Rochelle). 2021 Oct 26;2(1):497-499. doi: 10.1089/whr.2021.0079. eCollection 2021.
Background: PubMed 31777789Birru Talabi M, Eudy AM, Jayasundara M, Haroun T, Nowell WB, Curtis JR, Crow-Hercher R, White CW, Ginsberg S, Clowse MEB. Pregnancy, Periods, and "The Pill": Exploring the Reproductive Experiences of Women with Inflammatory Arthritis. ACR Open Rheumatol. 2019 Apr 15;1(2):125-132. doi: 10.1002/acr2.1016. eCollection 2019 Apr.
Background: PubMed 33181126Stransky OM, Wolgemuth T, Kazmerski T, Chodoff A, Borrero S, Birru Talabi M. Contraception decision-making and care among reproductive-aged women with autoimmune diseases. Contraception. 2021 Feb;103(2):86-91. doi: 10.1016/j.contraception.2020.11.001. Epub 2020 Nov 9.
Background: PubMed 32374928Wolgemuth T, Stransky OM, Chodoff A, Kazmerski TM, Clowse MEB, Birru Talabi M. Exploring the Preferences of Women Regarding Sexual and Reproductive Health Care in the Context of Rheumatology: A Qualitative Study. Arthritis Care Res (Hoboken). 2021 Aug;73(8):1194-1200. doi: 10.1002/acr.24249. Epub 2021 Jul 14.
Background: PubMed 30875455Birru Talabi M, Clowse MEB, Blalock SJ, Hamm M, Borrero S. Perspectives of Adult Rheumatologists Regarding Family Planning Counseling and Care: A Qualitative Study. Arthritis Care Res (Hoboken). 2020 Mar;72(3):452-458. doi: 10.1002/acr.23872.
Background: PubMed 19909547Frosch DL, Legare F, Fishbein M, Elwyn G. Adjuncts or adversaries to shared decision-making? Applying the Integrative Model of behavior to the role and design of decision support interventions in healthcare interactions. Implement Sci. 2009 Nov 12;4:73. doi: 10.1186/1748-5908-4-73.
Background: PubMed 28402085Stacey D, Legare F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017 Apr 12;4(4):CD001431. doi: 10.1002/14651858.CD001431.pub5.
Background: PubMed 15471770O'Connor AM, Llewellyn-Thomas HA, Flood AB. Modifying unwarranted variations in health care: shared decision making using patient decision aids. Health Aff (Millwood). 2004;Suppl Variation:VAR63-72. doi: 10.1377/hlthaff.var.63.
Background: PubMed 34114738Birru Talabi M, Eudy AM, Jayasundara M, Haroun T, Nowell WB, Curtis JR, Crow-Hercher R, White W, Ginsberg S, Clowse MEB. Tough Choices: Exploring Medication Decision-Making During Pregnancy and Lactation Among Women With Inflammatory Arthritis. ACR Open Rheumatol. 2021 Jul;3(7):475-483. doi: 10.1002/acr2.11240. Epub 2021 Jun 11.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Mehret S Birru Talabi, MD, PhD principal investigator

University of Pittsburgh

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MyVoice:Rheum and Pamphlet in people with Rheumatic Diseases and Physician-Patient Relations, run by University of Pittsburgh at 2 sites 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 1 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 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 30 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Acceptability of Intervention (time frame: T2 (within 24 hours of intervention and appointment)). The study lists 3 primary outcomes in all. 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 NCT04879745, which also lists 31 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 30 Apr 2024.