Multiple SclerosisNCT04257071
Out of Pocket Cost Communication in Multiple Sclerosis Patients
A study testing OOP Cost Communication and Optimization in people with Multiple Sclerosis, run by Emory University at 1 site in United States.
Trial summary
This is a prospective randomized controlled trial of a cohort of adult multiple sclerosis (MS) patients visiting an outpatient neurology clinic. Sixty participants will be randomly assigned to the intervention arm or a control arm and will be followed for three months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- OOP Cost Communication and Optimization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2020to 31 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- known diagnosis of MS as documented in the electronic medical record by a neurologist based on clinical and imaging findings
- a prescription for DMTs as medication
- not enrolled in a clinical trial that covers the cost of DMT
- have capacity to consent
Who cannot join
- plan to receive treatment elsewhere
- concurrent diagnosis of primary cancers (except for non-melanoma skin cancer)
- unable to read and speak English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Neurology Clinic, 12 Executive Park Drive
Atlanta, Georgia, 30329
About this study
Official title: Pilot Feasibility Study of Out-of-Pocket Cost Communication and Supportive Financial Services for Reducing Financial Toxicity Among Multiple Sclerosis Patients
This is a prospective randomized controlled trial of a cohort of adult multiple sclerosis (MS) patients visiting an outpatient neurology clinic. Sixty participants will be randomly assigned to the intervention arm or a control arm and will be followed for three months.
Read the detailed description
Patients with multiple sclerosis (MS) spend a substantial amount on healthcare services (total lifetime cost of $4.1 million), and rank second behind congestive heart failure in direct all-cause medical costs for chronic conditions. Among medically bankrupt families, MS is reported to be associated with the highest out-of-pocket expenditure (mean $34,167) followed by diabetes, injuries, stroke, mental illness, and heart disease. With increased costs of MS disease-modifying therapies (DMTs) over the last 20 years, relatively higher out-of-pocket (OOP) costs for advanced imaging tests compared to other common essential health benefits, and increased cost sharing, the financial burden on MS patients continues to escalate. More than half of MS patients lose their ability to generate incomes within a decade after diagnosis due to disability. Accordingly, these patients are at high risk for health-related financial toxicity (a term used interchangeably with financial distress or financial burden, first introduced in the oncology literature to report potential economic impact of modern oncology medications). Financial toxicity is defined as a combination of subjective financial concerns (e.g., anxiety), objective financial consequences of health issues and treatments (e.g., decreased income, medical debt, bankruptcy), and patients' coping behaviors. Financial toxicity, as measured by the Comprehensive Score for Financial Toxicity Patient-Reported Outcome (COST), can harm patients' health-related quality of life (HRQOL). Further, the financial burden from high cost-sharing medical services can be a risk factor for treatment non-adherence. To date, there are no published studies measuring financial toxicity in MS patients, and work in other disease states cannot necessarily be generalized to MS patients. First, the economic burden of MS is different from cancer due to early age of disease onset and its progressive disabling course. Additionally, since MS affects people in the most productive stages of their lives, the disease additionally carries important social burdens.
Providing patients with resources to proactively manage the costs of their care may help to reduce financial toxicity. However, financial navigation, must be provided in a manner that is acceptable, accessible, less cumbersome, thereby not affecting the flow of clinical care. In order to better understand how to equip patients with tools that have the potential to reduce financial toxicity, there is an urgent need to study interventions at the patient, clinic, payer, and policy level.
This is a two-arm, randomized trial with 60 adult MS patients who are receiving disease modifying therapy to test the feasibility of OOP cost communication and optimization through centralized financial navigation and explore its efficacy to reduce financial toxicity and care non-adherence compared to usual care.
- Conditions
- Multiple Sclerosis
- Being tested
- Usual Care, OOP Cost Communication and Optimization
- Keywords
- Financial toxicity, Financial burden, Financial distress, Medical expense, Out of Pocket cost, Cost communication, Cost optimization, Price transparency, Financial navigation
- Medical subject headings
- Multiple Sclerosis, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
The usual care for MS involves standard patient neurology visits and encounters with pharmacists, financial counselors and social workers if patients need any financial assistance with medication or other expenses.
OOP Cost Communication and OptimizationBehavioural
OOP Cost Communication and Optimization includes personalized discussion of OOP cost estimates for treatment plan obtained through an online price transparency tool, personalized analysis of patients' expenses by financial counselor, and patient enrollment in any cost optimization opportunities for which patient is eligible using a comprehensive financial navigation program.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Participants randomized to the usual care study arm will receive the usual care for their MS. Receives: Behavioral: Usual Care |
| OOP Cost Communication and Optimization | Experimental | Participants in this study arm in addition to usual care, will receive a personalized discussion of their OOP cost estimates for treatment obtained through an online price transparency tool, personalized analysis of expenses by financial counselor, and enrollment in any cost optimization opportunities for which they are eligible using a comprehensive financial navigation program. Receives: Behavioral: Usual Care; Behavioral: OOP Cost Communication and Optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction Questionnaire
Patient satisfaction with their experience with the OOP cost discussion and financial counselors is assessed with a 14-item Patient Satisfaction Questionnaire. Participants report how much they agree with each statement on a scale of 1 (strongly disagree) to 5 (strongly agree). Total scores range from 14 to 70 where higher scores indicate greater satisfaction with the financial counselor experiences.
Measured: Month 3
Secondary outcomes (5)
Percentage of Patients Participating in Cost Conversations
Patient participation in cost conversations is defined as percentage of patients in intervention arm participating in the scheduled conversation to discuss OOP.
Measured: Month 3
Minutes of Patient Engagement in Cost Conversations
Patient engagement in cost conversations is defined as time (in minutes) that participants in the intervention arm spent discussing OOP cost with the financial counselor.
Measured: Month 3
Patient Adherence to Cost Optimization Program
Patient adherence to cost optimization program is defined as the percentage of completed monthly contacts that participants in intervention arm have with study financial counselor.
Measured: Month 3
Change in Utilization of Financial Supportive Services
Use of financial supportive services will be assessed by asking participants if they received any assistance with paying for medication, imaging, or transportation to health provider visits in the past three months. For any financial support received, participants will be asked how they were linked to assistance. This is a qualitative assessment which does not provide a summary score.
Measured: Baseline, Month 3
Accuracy of OOP Cost Estimates
Accuracy of OOP cost estimates provided to patients in the intervention arm will be assessed by comparing the estimates to the amount stated in received medical bills, in a subset of patients who received medical bills.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start3 Mar 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Emory 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Gelareh Sadigh, Emory University
- Investigators
- Gelareh Sadigh, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257071
- Sponsor's protocol ID
- IRB00113357
- Status last verified
- Feb 2022
- First submitted
- 4 Feb 2020
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the manuscript (including text, tables, figures, and appendices) will be made available for sharing, after deidentification.
Publications
Owens GM. Economic burden of multiple sclerosis and the role of managed sare organizations in multiple sclerosis management. Am J Manag Care. 2016 Jun;22(6 Suppl):s151-8.
PubMed 27356024Adelman G, Rane SG, Villa KF. The cost burden of multiple sclerosis in the United States: a systematic review of the literature. J Med Econ. 2013;16(5):639-47. doi: 10.3111/13696998.2013.778268. Epub 2013 Mar 7.
PubMed 23425293Himmelstein DU, Thorne D, Warren E, Woolhandler S. Medical bankruptcy in the United States, 2007: results of a national study. Am J Med. 2009 Aug;122(8):741-6. doi: 10.1016/j.amjmed.2009.04.012. Epub 2009 Jun 6.
PubMed 19501347Hartung DM, Bourdette DN, Ahmed SM, Whitham RH. The cost of multiple sclerosis drugs in the US and the pharmaceutical industry: Too big to fail? Neurology. 2015 May 26;84(21):2185-92. doi: 10.1212/WNL.0000000000001608. Epub 2015 Apr 24.
PubMed 25911108Rumrill PD Jr, Roessler RT, McMahon BT, Hennessey ML, Neath J. Gender as a differential indicator of the employment discrimination experiences of Americans with multiple sclerosis. Work. 2007;29(4):303-11.
PubMed 18057570de Souza JA, Yap B, Ratain MJ, Daugherty C. User beware: we need more science and less art when measuring financial toxicity in oncology. J Clin Oncol. 2015 Apr 20;33(12):1414-5. doi: 10.1200/JCO.2014.59.4986. Epub 2015 Mar 2. No abstract available.
PubMed 25732158Altice CK, Banegas MP, Tucker-Seeley RD, Yabroff KR. Financial Hardships Experienced by Cancer Survivors: A Systematic Review. J Natl Cancer Inst. 2016 Oct 20;109(2):djw205. doi: 10.1093/jnci/djw205. Print 2017 Feb.
PubMed 27754926de Souza JA, Yap BJ, Hlubocky FJ, Wroblewski K, Ratain MJ, Cella D, Daugherty CK. The development of a financial toxicity patient-reported outcome in cancer: The COST measure. Cancer. 2014 Oct 15;120(20):3245-53. doi: 10.1002/cncr.28814. Epub 2014 Jun 20.
PubMed 24954526de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araujo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7.
PubMed 27716900Streeter SB, Schwartzberg L, Husain N, Johnsrud M. Patient and plan characteristics affecting abandonment of oral oncolytic prescriptions. J Oncol Pract. 2011 May;7(3 Suppl):46s-51s. doi: 10.1200/JOP.2011.000316.
PubMed 21886519Lizan L, Comellas M, Paz S, Poveda JL, Meletiche DM, Polanco C. Treatment adherence and other patient-reported outcomes as cost determinants in multiple sclerosis: a review of the literature. Patient Prefer Adherence. 2014 Dec 4;8:1653-64. doi: 10.2147/PPA.S67253. eCollection 2014.
PubMed 25525341Benito-Leon J. Multiple sclerosis: is prevalence rising and if so why? Neuroepidemiology. 2011;37(3-4):236-7. doi: 10.1159/000334606. Epub 2011 Nov 30. No abstract available.
PubMed 22133765Jensen S, Given B. Fatigue affecting family caregivers of cancer patients. Support Care Cancer. 1993 Nov;1(6):321-5. doi: 10.1007/BF00364970.
PubMed 8156250Shankaran V, Leahy T, Steelquist J, Watabayashi K, Linden H, Ramsey S, Schwartz N, Kreizenbeck K, Nelson J, Balch A, Singleton E, Gallagher K, Overstreet K. Pilot Feasibility Study of an Oncology Financial Navigation Program. J Oncol Pract. 2018 Feb;14(2):e122-e129. doi: 10.1200/JOP.2017.024927. Epub 2017 Dec 22.
PubMed 29272200Rosenkrantz AB, Sadigh G, Carlos RC, Silva E 3rd, Duszak R Jr. Out-of-Pocket Costs for Advanced Imaging Across the US Private Insurance Marketplace. J Am Coll Radiol. 2018 Apr;15(4):607-614.e1. doi: 10.1016/j.jacr.2017.12.010. Epub 2018 Feb 22.
PubMed 29477290
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study of Out-of-Pocket Cost Communication and Supportive Financial Services for Reducing Financial Toxicity Among Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04257071
- Acronym / sponsor ID
- IRB00113357
- Conditions
- Multiple Sclerosis
- Keywords
- Financial toxicity, Financial burden, Financial distress, Medical expense, Out of Pocket cost, Cost communication, Cost optimization, Price transparency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Feb 2020 (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 is a prospective randomized controlled trial of a cohort of adult multiple sclerosis (MS) patients visiting an outpatient neurology clinic. Sixty participants will be randomly assigned to the intervention arm or a control arm and will be followed for three months.
Detailed description
Patients with multiple sclerosis (MS) spend a substantial amount on healthcare services (total lifetime cost of $4.1 million), and rank second behind congestive heart failure in direct all-cause medical costs for chronic conditions. Among medically bankrupt families, MS is reported to be associated with the highest out-of-pocket expenditure (mean $34,167) followed by diabetes, injuries, stroke, mental illness, and heart disease. With increased costs of MS disease-modifying therapies (DMTs) over the last 20 years, relatively higher out-of-pocket (OOP) costs for advanced imaging tests compared to other common essential health benefits, and increased cost sharing, the financial burden on MS patients continues to escalate. More than half of MS patients lose their ability to generate incomes within a decade after diagnosis due to disability. Accordingly, these patients are at high risk for health-related financial toxicity (a term used interchangeably with financial distress or financial burden, first introduced in the oncology literature to report potential economic impact of modern oncology medications). Financial toxicity is defined as a combination of subjective financial concerns (e.g., anxiety), objective financial consequences of health issues and treatments (e.g., decreased income, medical debt, bankruptcy), and patients' coping behaviors. Financial toxicity, as measured by the Comprehensive Score for Financial Toxicity Patient-Reported Outcome (COST), can harm patients' health-related quality of life (HRQOL). Further, the financial burden from high cost-sharing medical services can be a risk factor for treatment non-adherence. To date, there are no published studies measuring financial toxicity in MS patients, and work in other disease states cannot necessarily be generalized to MS patients. First, the economic burden of MS is different from cancer due to early age of disease onset and its progressive disabling course. Additionally, since MS affects people in the most productive stages of their lives, the disease additionally carries important social burdens.
Providing patients with resources to proactively manage the costs of their care may help to reduce financial toxicity. However, financial navigation, must be provided in a manner that is acceptable, accessible, less cumbersome, thereby not affecting the flow of clinical care. In order to better understand how to equip patients with tools that have the potential to reduce financial toxicity, there is an urgent need to study interventions at the patient, clinic, payer, and policy level.
This is a two-arm, randomized trial with 60 adult MS patients who are receiving disease modifying therapy to test the feasibility of OOP cost communication and optimization through centralized financial navigation and explore its efficacy to reduce financial toxicity and care non-adherence compared to usual care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual CareParticipants randomized to the usual care study arm will receive the usual care for their MS. |
| OOP Cost Communication and Optimization | Experimental | Behavioral: Usual Care, Behavioral: OOP Cost Communication and OptimizationParticipants in this study arm in addition to usual care, will receive a personalized discussion of their OOP cost estimates for treatment obtained through an online price transparency tool, personalized analysis of expenses by financial counselor, and enrollment in any cost optimization opportunities for which they are eligible using a comprehensive financial navigation program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- known diagnosis of MS as documented in the electronic medical record by a neurologist based on clinical and imaging findings
- a prescription for DMTs as medication
- not enrolled in a clinical trial that covers the cost of DMT
- have capacity to consent
Key exclusion criteria (3 listed)
- plan to receive treatment elsewhere
- concurrent diagnosis of primary cancers (except for non-melanoma skin cancer)
- unable to read and speak English.
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 |
|---|---|---|
| Usual CareThe usual care for MS involves standard patient neurology visits and encounters with pharmacists, financial counselors and social workers if patients need any financial assistance with medication or other expenses. | Behavioural | OOP Cost Communication and Optimization, Usual Care |
| OOP Cost Communication and OptimizationOOP Cost Communication and Optimization includes personalized discussion of OOP cost estimates for treatment plan obtained through an online price transparency tool, personalized analysis of patients' expenses by financial counselor, and patient enrollment in any cost optimization opportunities for which patient is eligible using a comprehensive financial navigation program. | Behavioural | OOP Cost Communication and Optimization |
Primary outcome
Patient Satisfaction Questionnaire
Time frame: Month 3
Patient satisfaction with their experience with the OOP cost discussion and financial counselors is assessed with a 14-item Patient Satisfaction Questionnaire. Participants report how much they agree with each statement on a scale of 1 (strongly disagree) to 5 (strongly agree). Total scores range from 14 to 70 where higher scores indicate greater satisfaction with the financial counselor experiences.
5 secondary outcomes
Percentage of Patients Participating in Cost Conversations
Time frame: Month 3
Minutes of Patient Engagement in Cost Conversations
Time frame: Month 3
Patient Adherence to Cost Optimization Program
Time frame: Month 3
Change in Utilization of Financial Supportive Services
Time frame: Baseline, Month 3
Accuracy of OOP Cost Estimates
Time frame: Month 3
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 18 Feb 2022.
- Background: PubMed 27356024Owens GM. Economic burden of multiple sclerosis and the role of managed sare organizations in multiple sclerosis management. Am J Manag Care. 2016 Jun;22(6 Suppl):s151-8.
- Background: PubMed 23425293Adelman G, Rane SG, Villa KF. The cost burden of multiple sclerosis in the United States: a systematic review of the literature. J Med Econ. 2013;16(5):639-47. doi: 10.3111/13696998.2013.778268. Epub 2013 Mar 7.
- Background: PubMed 19501347Himmelstein DU, Thorne D, Warren E, Woolhandler S. Medical bankruptcy in the United States, 2007: results of a national study. Am J Med. 2009 Aug;122(8):741-6. doi: 10.1016/j.amjmed.2009.04.012. Epub 2009 Jun 6.
- Background: PubMed 25911108Hartung DM, Bourdette DN, Ahmed SM, Whitham RH. The cost of multiple sclerosis drugs in the US and the pharmaceutical industry: Too big to fail? Neurology. 2015 May 26;84(21):2185-92. doi: 10.1212/WNL.0000000000001608. Epub 2015 Apr 24.
- Background: PubMed 18057570Rumrill PD Jr, Roessler RT, McMahon BT, Hennessey ML, Neath J. Gender as a differential indicator of the employment discrimination experiences of Americans with multiple sclerosis. Work. 2007;29(4):303-11.
- Background: PubMed 25732158de Souza JA, Yap B, Ratain MJ, Daugherty C. User beware: we need more science and less art when measuring financial toxicity in oncology. J Clin Oncol. 2015 Apr 20;33(12):1414-5. doi: 10.1200/JCO.2014.59.4986. Epub 2015 Mar 2. No abstract available.
- Background: PubMed 27754926Altice CK, Banegas MP, Tucker-Seeley RD, Yabroff KR. Financial Hardships Experienced by Cancer Survivors: A Systematic Review. J Natl Cancer Inst. 2016 Oct 20;109(2):djw205. doi: 10.1093/jnci/djw205. Print 2017 Feb.
- Background: PubMed 24954526de Souza JA, Yap BJ, Hlubocky FJ, Wroblewski K, Ratain MJ, Cella D, Daugherty CK. The development of a financial toxicity patient-reported outcome in cancer: The COST measure. Cancer. 2014 Oct 15;120(20):3245-53. doi: 10.1002/cncr.28814. Epub 2014 Jun 20.
- Background: PubMed 27716900de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araujo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7.
- Background: PubMed 21886519Streeter SB, Schwartzberg L, Husain N, Johnsrud M. Patient and plan characteristics affecting abandonment of oral oncolytic prescriptions. J Oncol Pract. 2011 May;7(3 Suppl):46s-51s. doi: 10.1200/JOP.2011.000316.
- Background: PubMed 25525341Lizan L, Comellas M, Paz S, Poveda JL, Meletiche DM, Polanco C. Treatment adherence and other patient-reported outcomes as cost determinants in multiple sclerosis: a review of the literature. Patient Prefer Adherence. 2014 Dec 4;8:1653-64. doi: 10.2147/PPA.S67253. eCollection 2014.
- Background: PubMed 22133765Benito-Leon J. Multiple sclerosis: is prevalence rising and if so why? Neuroepidemiology. 2011;37(3-4):236-7. doi: 10.1159/000334606. Epub 2011 Nov 30. No abstract available.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the manuscript (including text, tables, figures, and appendices) will be made available for sharing, after deidentification.
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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.
Gelareh Sadigh, MD principal investigator
Emory 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 OOP Cost Communication and Optimization in people with Multiple Sclerosis, run by Emory 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 4 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: finished, as of the sponsor's last update on 18 Feb 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?
Patient Satisfaction Questionnaire (time frame: Month 3). 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 NCT04257071, which also lists 16 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 18 Feb 2022.