Cystic FibrosisNCT06030206
Lung Transplant READY CF 2: A Multi-site RCT
A study testing Investigator-designed lung transplant education resource (Research Intervention) in people with Cystic Fibrosis, run by University of Washington at 11 sites in United States.
Trial summary
Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more people with CF and low lung function die each year than undergo lung transplant. More than half of people with CF who die without a lung transplant were never referred for consideration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Investigator-designed lung transplant education resource (Research Intervention)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 11 sitesUnited States
- Study dates
- 6 Sep 2023to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cystic fibrosis
- FEV1 less than 50% of predicted
Who cannot join
- People who are unable to provide informed consent
- People who are lung transplant recipients
- Unable to read or understand English or Spanish to complete surveys or access the website (currently only available in English and Spanish)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Johns Hopkins University
Baltimore, Maryland, 21205
University of Cincinnati
Cincinnati, Ohio, 45267
National Jewish Health
Denver, Colorado, 80206
Baylor College of Medicine
Houston, Texas, 77030
University of Kansas
Kansas City, Kansas, 66160
University of California at Los Angeles (UCLA)
Los Angeles, California, 980095
University of Minnesota
Minneapolis, Minnesota, 55455
Yale University
New Haven, Connecticut, 06520
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Maine Health
Portland, Maine, 04102
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
About this study
Official title: Preparation for Lung Transplant Discussions and Decisions Among People With Cystic Fibrosis
Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more people with CF and low lung function die each year than undergo lung transplant. More than half of people with CF who die without a lung transplant were never referred for consideration. Patient preference not to undergo lung transplant may account for 25-40% of decisions to defer referral. Rates of death without transplant are higher for people with CF who are members of marginalized communities, including those with Black race, Hispanic ethnicity, or low socioeconomic status. Increasing awareness of lung transplant among people with CF, and promoting understanding of the risks and benefits of transplant, can potentially reduce the number of people with CF who die without a lung transplant.
The CF Foundation (CFF) lung transplant referral guidelines were developed to optimize the timing of referral for lung transplant. These guidelines recommend annual conversations with people with CF once their forced expiratory volume in one second (FEV1) is <50% predicted. Considering lung transplant as a treatment option before it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist.
Read more
Investigators are interested in understanding how people with CF use lung transplant educational resources and how one prepares for having discussions and/or making decisions about lung transplant as a treatment option for advanced CF. The purpose of this study is to test whether a research website improves patient preparedness for discussions about lung transplant. Investigators also aim to understand whether there are unique factors that affect people with CF from communities with decreased access to transplant ("communities of concern").
Study involvement will span 6 months and study activities will involve the following:
- Four Zoom research sessions (15-30 minutes each)
- Survey assessments
- Access to a research website that contains educational resources about lung transplant
- Audio recording of a routine CF clinic visit to determine if and how lung transplant is discussed between a participant and his/her/their CF doctor
Read the detailed description
Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more people with CF with forced expiratory volume in 1 second (FEV1) less than 30% of predicted die each year than undergo lung transplant. More than half of people with CF who die without lung transplant were never referred for consideration, with patients of lower socioeconomic status, Black race, or Hispanic ethnicity disproportionately impacted by limited access to lung transplant. Patient preference not to undergo lung transplant may account for 25-40% of decisions to defer referral. The CF Foundation established lung transplant referral guidelines that recommend people with CF have annual conversations about lung transplant with their CF doctor once their FEV1 is less than 50% of predicted. Considering lung transplant as a treatment option before it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist. By introducing an educational resource that can increase awareness of lung transplant among patients, and promote understanding of the risks and benefits of lung transplant, investigators aim to empower people with CF to take part in shared decision-making with their CF providers, which could reduce the number of people with CF who die without lung transplant.
Based on prior research, investigators developed a novel lung transplant educational resource that addresses patient-identified knowledge gaps and provides personalized educational content to help people with CF prepare for lung transplant discussions and decisions. The web-based educational resource couples real-life CF patient experiences of lung transplant in the form of personal narratives with up-to-date, CF-specific, and guideline-based medical information about lung transplant.
The overall research objectives for this study are to test the efficacy of the investigator-designed educational resource to improve patient preparedness for shared decision making about lung transplant and knowledge about lung transplant, and to evaluate the impact on mental health outcomes (depression and anxiety). The investigator-designed website will be compared to an attention control website to better understand how people with CF use and rank different educational resources' utility. The central hypothesis is that use of the new investigator-designed website that incorporates disease severity data (FEV1 % predicted, supplemental oxygen use, exacerbations) to identify relevant personal narratives and guideline-based educational content will increase a patient's preparedness to engage in discussions about lung transplant beyond the standard information presented on the attention control website.
The study will be a randomized controlled trial. Participants will be randomly assigned 1:1 to one of two educational resources, described above, stratified by FEV1 category (FEV1 30-50% or FEV1 <30% of predicted), CF Center, and whether they are members of the "communities of concern"). The communities of concern include people with Medicaid insurance, high school education or less, Hispanic ethnicity, or Black/Asian/Other race (not White race). Baseline surveys will evaluate knowledge about lung transplant, a Likert scale rating of preparedness for lung transplant discussions, decisional conflict about lung transplant, and mental health. For three months, participants will have access to one of two educational resources via a login to a secure research website. At 2 weeks, there will be a study visit that includes repeated surveys from baseline and the Preparedness for Shared Decision Making (PrepDM) Scale. At 2 to 3 months after randomization, participants will have a routine CF clinic visit, which may be audio-recorded for evaluation of lung transplant discussion. At 3 months after randomization, there will be a study visit that includes repeated surveys from baseline and the PrepDM Scale. After the 3-month study visit, participants will have access to both educational resources via individual login to the secure research website. At 6-months, there will be a study visit to repeat the surveys. Throughout the 6-months and for a long-term follow up period of 4 years, web analytics will be captured at the individual level to determine usage patterns for both educational resources.
- Conditions
- Cystic Fibrosis
- Being tested
- Investigator-designed lung transplant education resource (Research Intervention), Publicly available transplant education resource (Attention-control)
- Keywords
- Cystic Fibrosis, Lung Transplantation, Advanced Lung Disease, Decision Support Tool
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigator-designed lung transplant education resource (Research Intervention)Behavioural
Participants will access the investigator-designed educational resource via their login to a secure website. After three months, participants will gain access to the publicly available website (attention control) and will have an additional three months of access to both of these resources.
Publicly available transplant education resource (Attention-control)Behavioural
Participants will access the publicly available education resource via their login to a secure website. After three months, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional three months of access to both of these resources.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Access to an investigator-designed web-based educational resource with information about lung transplant for three months. Receives: Behavioral: Investigator-designed lung transplant education resource (Research Intervention) |
| Attention-control | Active comparator | Access to a publicly available web-based educational resource with information about transplant for three months. Receives: Behavioral: Publicly available transplant education resource (Attention-control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preparedness for Shared Decision Making (PrepDM) Scale
The primary endpoint is an intention-to-treat assessment of the difference in mean Preparedness for Shared Decision Making (PrepDM) Scale in the intervention versus attention-control arms of the study at the 3-month study visit using linear mixed models. Scores range on a scale from 0 to 100 with higher scores indicating a higher perceived level of preparation for decision making.
Measured: Measured at the 3-month study visit
Secondary outcomes (5)
Confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey)
Difference in mean change in confidence-weighted true false (CTF) knowledge score will be measured in the intervention versus control arms of the study using linear mixed models. CTF scoring adds points for certainty in correct responses and deducts points for certainty in incorrect responses. Participants receive +2 points when "sure" about a correct response, +1 if unsure about a correct response, -1 if unsure about an incorrect response and -2 if sure about an incorrect response. For a 14-item knowledge test, the maximum score is +28 and the minimum score is -28, with higher scores indicating more knowledge about lung transplant.
Measured: Measured at 3-month study visit
Decisional Conflict Scale
Decisional Conflict Scale change will be measured from the baseline study visit to the 3-month study visit. The intention-to-treat analysis will compare mean change in the Decisional Conflict Scale between the intervention and control arms of the study. Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict].
Measured: Baseline to 3-month study visit
Likert-scale rating of preparedness to discuss lung transplant (0-4)
Likert rating of preparedness to discuss lung transplant will be measured at each study visit (0=Don't know, 1= Not at all prepared, 2 = A little prepared, 3 = Moderately prepared, 4 = Very prepared). The intention-to-treat analysis will compare mean change in Likert-scale rating between the intervention and attention-control arms of the study using linear mixed models.
Measured: Measured at 3-month study visit
Patient Health Questionnaire (PHQ-9)
PHQ-9 is a scale that measures symptoms of depression in the prior 2 weeks on a 0-27 scale, with higher scores indicating worsening depression and a score of 10 or higher consistent with a diagnosis of depression. The intention-to-treat analysis will compare mean change in PHQ-9 between the intervention and attention-control arms of the study using linear mixed models. Investigators will also determine the proportion with new PHQ-9 score greater than or equal to 10 in each arm.
Measured: Measured at 3-month study visit
Generalized Anxiety Disorder 7-item (GAD-7) Scale
GAD-7 is a scale that measures symptoms of anxiety in the prior 2 weeks on a 0-21 scale, with higher scores indicating worsening anxiety and a score of 10 or higher consistent with a diagnosis of generalized anxiety disorder. The intention-to-treat analysis will compare mean change in GAD-7 between the intervention and attention-control arms of the study using linear mixed models. Investigators will also determine the proportion with new GAD-7 score greater than or equal to 10 in each arm.
Measured: Measured at 3-month study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start6 Sep 2023
- Primary completion30 Mar 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Kathleen Ramos, University of Washington
- Investigators
- Kathleen Ramos, MD, MSc, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030206
- Sponsor's protocol ID
- STUDY00016585
- Other IDs
- 1R01NR020470-01A1
- Status last verified
- Dec 2025
- First submitted
- 25 Aug 2023
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) may be shared with other researchers for secondary analyses with the approval of the appropriate Human Subjects Division(s) and the study's principal investigator (PI).
Publications
Ramos KJ, Smith PJ, McKone EF, Pilewski JM, Lucy A, Hempstead SE, Tallarico E, Faro A, Rosenbluth DB, Gray AL, Dunitz JM; CF Lung Transplant Referral Guidelines Committee. Lung transplant referral for individuals with cystic fibrosis: Cystic Fibrosis Foundation consensus guidelines. J Cyst Fibros. 2019 May;18(3):321-333. doi: 10.1016/j.jcf.2019.03.002. Epub 2019 Mar 27.
PubMed 30926322Hartzler AL, Bartlett LE, Hobler MR, Reid N, Pryor JB, Kapnadak SG, Berry DL, Lober WB, Goss CH, Ramos KJ; Take on Transplant Study Group. Take on transplant: human-centered design of a patient education tool to facilitate informed discussions about lung transplant among people with cystic fibrosis. J Am Med Inform Assoc. 2022 Dec 13;30(1):26-37. doi: 10.1093/jamia/ocac176.
PubMed 36173364
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparation for Lung Transplant Discussions and Decisions Among People With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT06030206
- Acronym / sponsor ID
- STUDY00016585
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Lung Transplantation, Advanced Lung Disease, Decision Support Tool
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 8 Sep 2023 (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.
Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more people with CF and low lung function die each year than undergo lung transplant. More than half of people with CF who die without a lung transplant were never referred for consideration. Patient preference not to undergo lung transplant may account for 25-40% of decisions to defer referral. Rates of death without transplant are higher for people with CF who are members of marginalized communities, including those with Black race, Hispanic ethnicity, or low socioeconomic status. Increasing awareness of lung transplant among people with CF, and promoting understanding of the risks and benefits of transplant, can potentially reduce the number of people with CF who die without a lung transplant.
The CF Foundation (CFF) lung transplant referral guidelines were developed to optimize the timing of referral for lung transplant. These guidelines recommend annual conversations with people with CF once their forced expiratory volume in one second (FEV1) is <50% predicted. Considering lung transplant as a treatment option before it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist.
Investigators are interested in understanding how people with CF use lung transplant educational resources and how one prepares for having discussions and/or making decisions about lung transplant as a treatment option for advanced CF. The purpose of this study is to test whether a research website improves patient preparedness for discussions about lung transplant. Investigators also aim to understand whether there are unique factors that affect people with CF from communities with decreased access to transplant ("communities of concern").
Study involvement will span 6 months and study activities will involve the following:
- Four Zoom research sessions (15-30 minutes each)
- Survey assessments
- Access to a research website that contains educational resources about lung transplant
- Audio recording of a routine CF clinic visit to determine if and how lung transplant is discussed between a participant and his/her/their CF doctor
Detailed description
Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more people with CF with forced expiratory volume in 1 second (FEV1) less than 30% of predicted die each year than undergo lung transplant. More than half of people with CF who die without lung transplant were never referred for consideration, with patients of lower socioeconomic status, Black race, or Hispanic ethnicity disproportionately impacted by limited access to lung transplant. Patient preference not to undergo lung transplant may account for 25-40% of decisions to defer referral. The CF Foundation established lung transplant referral guidelines that recommend people with CF have annual conversations about lung transplant with their CF doctor once their FEV1 is less than 50% of predicted. Considering lung transplant as a treatment option before it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist. By introducing an educational resource that can increase awareness of lung transplant among patients, and promote understanding of the risks and benefits of lung transplant, investigators aim to empower people with CF to take part in shared decision-making with their CF providers, which could reduce the number of people with CF who die without lung transplant.
Based on prior research, investigators developed a novel lung transplant educational resource that addresses patient-identified knowledge gaps and provides personalized educational content to help people with CF prepare for lung transplant discussions and decisions. The web-based educational resource couples real-life CF patient experiences of lung transplant in the form of personal narratives with up-to-date, CF-specific, and guideline-based medical information about lung transplant.
The overall research objectives for this study are to test the efficacy of the investigator-designed educational resource to improve patient preparedness for shared decision making about lung transplant and knowledge about lung transplant, and to evaluate the impact on mental health outcomes (depression and anxiety). The investigator-designed website will be compared to an attention control website to better understand how people with CF use and rank different educational resources' utility. The central hypothesis is that use of the new investigator-designed website that incorporates disease severity data (FEV1 % predicted, supplemental oxygen use, exacerbations) to identify relevant personal narratives and guideline-based educational content will increase a patient's preparedness to engage in discussions about lung transplant beyond the standard information presented on the attention control website.
The study will be a randomized controlled trial. Participants will be randomly assigned 1:1 to one of two educational resources, described above, stratified by FEV1 category (FEV1 30-50% or FEV1 <30% of predicted), CF Center, and whether they are members of the "communities of concern"). The communities of concern include people with Medicaid insurance, high school education or less, Hispanic ethnicity, or Black/Asian/Other race (not White race). Baseline surveys will evaluate knowledge about lung transplant, a Likert scale rating of preparedness for lung transplant discussions, decisional conflict about lung transplant, and mental health. For three months, participants will have access to one of two educational resources via a login to a secure research website. At 2 weeks, there will be a study visit that includes repeated surveys from baseline and the Preparedness for Shared Decision Making (PrepDM) Scale. At 2 to 3 months after randomization, participants will have a routine CF clinic visit, which may be audio-recorded for evaluation of lung transplant discussion. At 3 months after randomization, there will be a study visit that includes repeated surveys from baseline and the PrepDM Scale. After the 3-month study visit, participants will have access to both educational resources via individual login to the secure research website. At 6-months, there will be a study visit to repeat the surveys. Throughout the 6-months and for a long-term follow up period of 4 years, web analytics will be captured at the individual level to determine usage patterns for both educational resources.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Investigator-designed lung transplant education resource (Research Intervention)Access to an investigator-designed web-based educational resource with information about lung transplant for three months. |
| Attention-control | Active comparator | Behavioral: Publicly available transplant education resource (Attention-control)Access to a publicly available web-based educational resource with information about transplant for three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of cystic fibrosis
- FEV1 less than 50% of predicted
Key exclusion criteria (3 listed)
- People who are unable to provide informed consent
- People who are lung transplant recipients
- Unable to read or understand English or Spanish to complete surveys or access the website (currently only available in English and Spanish)
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 |
|---|---|---|
| Investigator-designed lung transplant education resource (Research Intervention)Participants will access the investigator-designed educational resource via their login to a secure website. After three months, participants will gain access to the publicly available website (attention control) and will have an additional three months of access to both of these resources. | Behavioural | Intervention |
| Publicly available transplant education resource (Attention-control)Participants will access the publicly available education resource via their login to a secure website. After three months, participants will gain access to the investigator-designed educational resource (research intervention) and will have an additional three months of access to both of these resources. | Behavioural | Attention-control |
Primary outcome
Preparedness for Shared Decision Making (PrepDM) Scale
Time frame: Measured at the 3-month study visit
The primary endpoint is an intention-to-treat assessment of the difference in mean Preparedness for Shared Decision Making (PrepDM) Scale in the intervention versus attention-control arms of the study at the 3-month study visit using linear mixed models. Scores range on a scale from 0 to 100 with higher scores indicating a higher perceived level of preparation for decision making.
5 secondary outcomes
Confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey)
Time frame: Measured at 3-month study visit
Decisional Conflict Scale
Time frame: Baseline to 3-month study visit
Likert-scale rating of preparedness to discuss lung transplant (0-4)
Time frame: Measured at 3-month study visit
Patient Health Questionnaire (PHQ-9)
Time frame: Measured at 3-month study visit
Generalized Anxiety Disorder 7-item (GAD-7) Scale
Time frame: Measured at 3-month study visit
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 5 Jan 2026.
- Background: PubMed 30926322Ramos KJ, Smith PJ, McKone EF, Pilewski JM, Lucy A, Hempstead SE, Tallarico E, Faro A, Rosenbluth DB, Gray AL, Dunitz JM; CF Lung Transplant Referral Guidelines Committee. Lung transplant referral for individuals with cystic fibrosis: Cystic Fibrosis Foundation consensus guidelines. J Cyst Fibros. 2019 May;18(3):321-333. doi: 10.1016/j.jcf.2019.03.002. Epub 2019 Mar 27.
- Background: PubMed 36173364Hartzler AL, Bartlett LE, Hobler MR, Reid N, Pryor JB, Kapnadak SG, Berry DL, Lober WB, Goss CH, Ramos KJ; Take on Transplant Study Group. Take on transplant: human-centered design of a patient education tool to facilitate informed discussions about lung transplant among people with cystic fibrosis. J Am Med Inform Assoc. 2022 Dec 13;30(1):26-37. doi: 10.1093/jamia/ocac176.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) may be shared with other researchers for secondary analyses with the approval of the appropriate Human Subjects Division(s) and the study's principal investigator (PI).
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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.
Kathleen Ramos, MD, MSc principal investigator
University of Washington
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigator-designed lung transplant education resource (Research Intervention) in people with Cystic Fibrosis, run by University of Washington at 11 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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
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?
Preparedness for Shared Decision Making (PrepDM) Scale (time frame: Measured at the 3-month study visit). 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 NCT06030206, which also lists 2 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 5 Jan 2026.