Cystic FibrosisNCT04825236
MyVoice:CF Decision Aid for Women With Cystic Fibrosis
A study testing MyVoice:CF in people with Cystic Fibrosis and Contraception, run by University of Pittsburgh at 1 site in United States.
Trial summary
This project is a single-center feasibility study of MyVoice:CF, a patient-facing, web-based decision aid. Aim 1) Assess the acceptability, feasibility, and usability of MyVoice:CF for women with CF and multidisciplinary adult CF providers. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Cystic Fibrosis, Contraception, Physician-Patient Relations
- What is being tested?
- MyVoice:CF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 3 Feb 2023
- 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 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Cisgender female
- Age 18-44 years
- English-speaking
- Diagnosed with cystic fibrosis
Who cannot join
- Men
- Women under 18 (this tool was not designed to appropriately address the sexual and reproductive health needs and experiences of the adolescent population)
- Patients who have no computer and internet access and would be unable to access the tool
- Patients who are unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Feasibility Trial of the MyVoice:CF Decision Aid to Address the Reproductive Health Needs of Women With Cystic Fibrosis
This project is a single-center feasibility study of MyVoice:CF, a patient-facing, web-based decision aid.
Aim 1) Assess the acceptability, feasibility, and usability of MyVoice:CF for women with CF and multidisciplinary adult CF providers.
Aim 2) Assess the preliminary efficacy of MyVoice:CF related to patient-provider communication, shared decision-making, knowledge, and self-efficacy for women with CF related to reproductive health concerns.
Read the detailed description
This study seeks to test a decision aid created to address the disease-specific reproductive health concerns of women with cystic fibrosis. The decision aid was built out of research done by studies previously approved by the University of Pittsburgh IRB. These studies determined the information and decision support needs of women with cystic fibrosis concerning their sexual and reproductive health care.
The purpose of this study is to pilot the decision aid prototype to evaluate its feasibility, appropriateness, and acceptability.
Screening for eligibility will be conducted prior to a potential participant's visit with their CF care team. Eligible patients will be contacted via phone. Interested patients will be consented and asked to schedule a time to complete the web-based decision aid in its entirety and complete a follow up qualitative interview.
The investigators will also ask participants if they are interested in two optional activities: having their screen activity on MyVoice:CF recorded for analysis and having their next appointment with their CF team recorded for conversation analyses. The RC will explain these recordings will be de-identified prior to analysis and that no one outside of the study team will see the screen capture data, listen to the recording, or read the full transcript.
Data collection: After giving consent to participate, participants will be given the link for the baseline survey, hosted on REDCap, by the RC/RA. They will also schedule a time to 1) complete the web-based decision aid and 2) complete an exit survey about the aid.
Immediately following their next visit with the CF care team, they will complete a survey to assess the tool's impact on their interaction with the team and their receipt of reproductive health care and complete a qualitative interview on the tool and its impact on their team interaction.
The subsequent 3-month and 6-month surveys will also be completed via REDCap, and participants will be given the link via email, with phone calls as necessary to prompt completion. Six months after the last recruited patient has completed their run through of the tool, the adult CF care team (n=11) will be asked to complete an anonymous survey about their experiences with patients who have used the tool. Following this, a focus group will be conducted with the care team to discuss the perceived feasibility, appropriateness, and acceptability of the tool from the provider perspective.
Data Analysis:
Descriptive statistics will summarize feasibility and acceptability data. The System Usability Scale will be assessed via the accepted scoring scale. The investigators aim for >80% use of the tool (REACH), implementation integrity (IMPLEMENTATION), and satisfaction with MyVoice:CF (MAINTENANCE). Effectiveness will be assessed by fitting generalized linear mixed models with fixed effects for "period" and random effects for cluster. For outcomes assessed longitudinally, there will be an additional random effect for subject. Assuming a conservative ICC of 0.05, 5% type I error, and 15% attrition, our anticipated sample size would yield 80% power to detect mean differences of 0.41 for any of our continuous outcomes. Reproductive health outcomes and care-seeking variables will be compared to estimates from recent survey data as well as the National Survey for Family Growth (NSFG) as a U.S. general population estimate. NSFG comparisons will be adjusted for demographic differences. Survey data will be analyzed using SAS v9.4.
Thematic analysis of interview transcripts will be conducted by research study staff and decision aid developers to identify key themes produced by the pilot testing process. Themes will be evaluated and used to refine the existing prototype and develop a finalized version of the decision making tool. Data collected from the decision aid will not be collected for research purposes and will not be analyzed; it will be used to test that the data collection system is functioning correctly.
- Being tested
- MyVoice:CF
- Keywords
- cystic fibrosis, shared decision-making, sexual and reproductive health
- Medical subject headings
- Cystic Fibrosis, Pregnancy Complications, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyVoice:CFOther
Participants will be given access to MyVoice:CF, a web-based decision aid (DA). This tool includes information about fertility, genetics, parenting, pregnancy, and breastfeeding within the context of cystic fibrosis (CF). The tool includes interactive elements designed to give users the ability to assess and reflect on their own reproductive goals and experiences and promote self-efficacy to engage in shared decision-making with their CF and women's health providers.
Upon completion of use of the decision aid, a summary sheet is generated based on the user's interaction with the tool. This summary is supplied to the provider prior to the next appointment.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid Users | Experimental | Patients with CF who are given access to the MyVoice:CF decision aid Receives: Other: MyVoice:CF |
| CF Healthcare Providers | Experimental | Members of the adult CF care team who interact with patients who have used the decision aid Receives: Other: MyVoice:CF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention
Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating higher acceptability.
Measured: Patients- T2 (within 24 hours of intervention)
Intervention Appropriateness Measure
Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating greater acceptability.
Measured: Patients- T2 (within 24 hours of intervention)
System Usability Scale
Ten-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating greater usability.
Measured: Patients- T2 (within 24 hours of intervention)
Perceived Value of Tool to Providers
Five-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating higher perceived value.
Measured: Providers- T5 (6 months after recruitment ends)
Acceptability of intervention to providers
Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating higher acceptability.
Measured: Providers- T5 (6 months after recruitment ends)
Intervention Appropriateness Measure for providers
Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating greater acceptability.
Measured: Providers- T5 (6 months after recruitment ends)
Secondary outcomes (15)
ReproKnow (adapted)
Completion of a 10-item multiple choice instrument adapted from ReproKnow, a validated instrument for assessing knowledge of reproductive health in rheumatic diseases. Answers will be coded as correct or incorrect. The percentage of correct responses across the 10 questions will be calculated for each participant. The score range is 0 to 100%. Participant knowledge will be measured at baseline and following their first clinic visit post-use of the tool to assess the sustained impact of the decision aid on knowledge.
Measured: T3 (up to 12 weeks post-tool use) compared to T0 (baseline)
Shared Decision-Making (collaboRATE)
Three-item measure with 5-point Likert scale questions of 0 (no effort was made) to 4 (every effort was made) to assess shared decision-making between patients and providers. The mean of all three items is calculated. Higher scores represent more shared decision-making.
Measured: T3 (up to 12 weeks post-tool use) ; T4 (up to 24 weeks post-tool use)
Perceived Efficacy in Patient-Physician Interactions
Five-item measure with 5-point Likert scale questions from 1 (not at all confident) to 5 (very confident). Score is determined by the sum (possible range of 5 to 25) with higher score indicating higher perceived efficacy in communicating with providers
Measured: T3 (up to 12 weeks post-tool use)
Reproductive Self Efficacy
Five-item measure with 5-point Likert scale questions from 1 (not at all confident) to 5 (very confident). Score is determined by the sum (possible range of 5 to 25) with higher score indicating higher perceived efficacy in communicating with providers.
Measured: T3 (up to 12 weeks post-tool use) compared to T0 (baseline)
Change in Pregnancy Intention
Desire to Avoid Pregnancy scale- 14-item measure with 5-point Likert scale questions from 0 (strongly agree) to 4 (strongly disagree). Score is determined by calculating the mean (range of 0-4) with higher scores reflecting a higher desire to avoid pregnancy
Measured: Change between T3 (up to 12 weeks post-tool use) and T0 (baseline)
Quantity and quality of reproductive conversations
Three-item measure. Did you discuss reproductive goals with your CF team- Yes/no/don't know; [if yes] Rate the quality of the discussion from 0 (very poor) to 4 (very good); [if no] why not discussed- Assessed by participant response to a multiple choice item asking why reproductive goals were not discussed (time, patient comfort, provider comfort, unfamiliar provider, other visit priorities, unsure, other)
Measured: T3 (up to 12 weeks post-tool use) ; T4 (up to 24 weeks post-tool use)
Participant Feedback to Tool
Informed by in-depth interviews with women about their likes and dislikes of the MyVoice tool, their perceived barriers and facilitators to its use, if/how MyVoice could be used in their own lives. Questions also assess whether the CF team discussed reproductive health and if/how MyVoice influenced those decisions.
Measured: T3 (up to 12 weeks post-tool use)
Participant Change in Contraceptive Use
Assessed by participant responses to a multiple choice item asking which methods of contraception they are currently using (in the past 2 weeks). Reasons for non-use assessed by response to a multiple choice item asking why they are not currently using contraception.
Measured: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
Participant Confidence in Contraceptive Method Selection
Assessed by participant responses to a 5-point Likert scale regarding satisfaction with current contraceptive method(s). Response options range from 1 ("Very Unsatisfied") to 5 ("Very Satisfied").
Measured: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
Participant number of pregnancies during study
Assessed by participant-reported survey responses to a Yes/No item about whether a pregnancy has occurred since enrollment.
Measured: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
Participant receipt of infertility care
Yes/No to question of whether pregnancy occurred with or without medical intervention; multiple choice question assessing what type of medical intervention was used.
Measured: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
Participant receipt of preconception counseling
Y/No to question of whether pregnancy was discussed prior to conception with health care provider; multiple choice question of source of preconception care
Measured: T4 (up to 24 weeks post-tool use)compared to T0 (baseline)
Participant Desire for future pregnancy
3-item measure assessing feelings about future pregnancy- question on desire for future child, question on preferred timing, question on emotional response if she became pregnant now.
Measured: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
Intent to breastfeed
1-item measure asking how participant would feed a future baby (breastfeeding, bottle feeding, combination, unknown)
Measured: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
Receipt of SRH care
Asks whether participant has visited a clinic for any of the following over the course of the study: birth control prescription, birth control counselling, pregnancy test, preconception counseling, prenatal care.
Measured: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Jul 2021
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Principal investigator, Traci Kazmerski, University of Pittsburgh
- Investigators
- Traci M Kazmerski, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825236
- Sponsor's protocol ID
- STUDY20050174
- Status last verified
- Feb 2023
- First submitted
- 19 Mar 2021
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial of the MyVoice:CF Decision Aid to Address the Reproductive Health Needs of Women With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04825236
- Acronym / sponsor ID
- STUDY20050174
- Keywords
- cystic fibrosis, shared decision-making, sexual and reproductive health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 1 Apr 2021 (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 project is a single-center feasibility study of MyVoice:CF, a patient-facing, web-based decision aid.
Aim 1) Assess the acceptability, feasibility, and usability of MyVoice:CF for women with CF and multidisciplinary adult CF providers.
Aim 2) Assess the preliminary efficacy of MyVoice:CF related to patient-provider communication, shared decision-making, knowledge, and self-efficacy for women with CF related to reproductive health concerns.
Detailed description
This study seeks to test a decision aid created to address the disease-specific reproductive health concerns of women with cystic fibrosis. The decision aid was built out of research done by studies previously approved by the University of Pittsburgh IRB. These studies determined the information and decision support needs of women with cystic fibrosis concerning their sexual and reproductive health care.
The purpose of this study is to pilot the decision aid prototype to evaluate its feasibility, appropriateness, and acceptability.
Screening for eligibility will be conducted prior to a potential participant's visit with their CF care team. Eligible patients will be contacted via phone. Interested patients will be consented and asked to schedule a time to complete the web-based decision aid in its entirety and complete a follow up qualitative interview.
The investigators will also ask participants if they are interested in two optional activities: having their screen activity on MyVoice:CF recorded for analysis and having their next appointment with their CF team recorded for conversation analyses. The RC will explain these recordings will be de-identified prior to analysis and that no one outside of the study team will see the screen capture data, listen to the recording, or read the full transcript.
Data collection: After giving consent to participate, participants will be given the link for the baseline survey, hosted on REDCap, by the RC/RA. They will also schedule a time to 1) complete the web-based decision aid and 2) complete an exit survey about the aid.
Immediately following their next visit with the CF care team, they will complete a survey to assess the tool's impact on their interaction with the team and their receipt of reproductive health care and complete a qualitative interview on the tool and its impact on their team interaction.
The subsequent 3-month and 6-month surveys will also be completed via REDCap, and participants will be given the link via email, with phone calls as necessary to prompt completion. Six months after the last recruited patient has completed their run through of the tool, the adult CF care team (n=11) will be asked to complete an anonymous survey about their experiences with patients who have used the tool. Following this, a focus group will be conducted with the care team to discuss the perceived feasibility, appropriateness, and acceptability of the tool from the provider perspective.
Data Analysis:
Descriptive statistics will summarize feasibility and acceptability data. The System Usability Scale will be assessed via the accepted scoring scale. The investigators aim for >80% use of the tool (REACH), implementation integrity (IMPLEMENTATION), and satisfaction with MyVoice:CF (MAINTENANCE). Effectiveness will be assessed by fitting generalized linear mixed models with fixed effects for "period" and random effects for cluster. For outcomes assessed longitudinally, there will be an additional random effect for subject. Assuming a conservative ICC of 0.05, 5% type I error, and 15% attrition, our anticipated sample size would yield 80% power to detect mean differences of 0.41 for any of our continuous outcomes. Reproductive health outcomes and care-seeking variables will be compared to estimates from recent survey data as well as the National Survey for Family Growth (NSFG) as a U.S. general population estimate. NSFG comparisons will be adjusted for demographic differences. Survey data will be analyzed using SAS v9.4.
Thematic analysis of interview transcripts will be conducted by research study staff and decision aid developers to identify key themes produced by the pilot testing process. Themes will be evaluated and used to refine the existing prototype and develop a finalized version of the decision making tool. Data collected from the decision aid will not be collected for research purposes and will not be analyzed; it will be used to test that the data collection system is functioning correctly.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision Aid Users | Experimental | Other: MyVoice:CFPatients with CF who are given access to the MyVoice:CF decision aid |
| CF Healthcare Providers | Experimental | Other: MyVoice:CFMembers of the adult CF care team who interact with patients who have used the decision aid |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Cisgender female
- Age 18-44 years
- English-speaking
- Diagnosed with cystic fibrosis
Key exclusion criteria (4 listed)
- Men
- Women under 18 (this tool was not designed to appropriately address the sexual and reproductive health needs and experiences of the adolescent population)
- Patients who have no computer and internet access and would be unable to access the tool
- Patients who are unable to consent
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:CFParticipants will be given access to MyVoice:CF, a web-based decision aid (DA). This tool includes information about fertility, genetics, parenting, pregnancy, and breastfeeding within the context of cystic fibrosis (CF). The tool includes interactive elements designed to give users the ability to assess and reflect on their own reproductive goals and experiences and promote self-efficacy to engage in shared decision-making with their CF and women's health providers. Upon completion of use of the decision aid, a summary sheet is generated based on the user's interaction with the tool. This summary is supplied to the provider prior to the next appointment. | Other | CF Healthcare Providers, Decision Aid Users |
Primary outcome
Acceptability of Intervention
Time frame: Patients- T2 (within 24 hours of intervention)
Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating higher acceptability.
Intervention Appropriateness Measure
Time frame: Patients- T2 (within 24 hours of intervention)
Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating greater acceptability.
System Usability Scale
Time frame: Patients- T2 (within 24 hours of intervention)
Ten-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating greater usability.
Perceived Value of Tool to Providers
Time frame: Providers- T5 (6 months after recruitment ends)
Five-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating higher perceived value.
Acceptability of intervention to providers
Time frame: Providers- T5 (6 months after recruitment ends)
Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating higher acceptability.
Intervention Appropriateness Measure for providers
Time frame: Providers- T5 (6 months after recruitment ends)
Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating greater acceptability.
15 secondary outcomes
ReproKnow (adapted)
Time frame: T3 (up to 12 weeks post-tool use) compared to T0 (baseline)
Shared Decision-Making (collaboRATE)
Time frame: T3 (up to 12 weeks post-tool use) ; T4 (up to 24 weeks post-tool use)
Perceived Efficacy in Patient-Physician Interactions
Time frame: T3 (up to 12 weeks post-tool use)
Reproductive Self Efficacy
Time frame: T3 (up to 12 weeks post-tool use) compared to T0 (baseline)
Change in Pregnancy Intention
Time frame: Change between T3 (up to 12 weeks post-tool use) and T0 (baseline)
Quantity and quality of reproductive conversations
Time frame: T3 (up to 12 weeks post-tool use) ; T4 (up to 24 weeks post-tool use)
Participant Feedback to Tool
Time frame: T3 (up to 12 weeks post-tool use)
Participant Change in Contraceptive Use
Time frame: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
Participant Confidence in Contraceptive Method Selection
Time frame: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
Participant number of pregnancies during study
Time frame: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
Participant receipt of infertility care
Time frame: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
Participant receipt of preconception counseling
Time frame: T4 (up to 24 weeks post-tool use)compared to T0 (baseline)
Participant Desire for future pregnancy
Time frame: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
Intent to breastfeed
Time frame: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
Receipt of SRH care
Time frame: T4 (up to 24 weeks post-tool use) compared to T0 (baseline)
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 6 Feb 2023.
- 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.
Traci M Kazmerski, MD, MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyVoice:CF in people with Cystic Fibrosis and Contraception, run by University of Pittsburgh 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 4 inclusion and 4 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 6 Feb 2023. 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?
Acceptability of Intervention (time frame: Patients- T2 (within 24 hours of intervention)). The study lists 6 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 6 Feb 2023.