Hearing Loss, FunctionalNCT04382703
A Self-Affirmation Intervention to Promote Hearing Aid Use
A study testing Self-Affirmation Exercise in people with Hearing Loss, Functional, run by University of Manchester.
Trial summary
Hearing aids are the number one treatment for hearing loss and it is estimated that out of the 2 million of UK individuals who are supplied with hearing aids 1.4 million will use their hearing aids to varying degrees and the other 0.6 million will stop using their hearing aids altogether. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Functional
- What is being tested?
- Self-Affirmation Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2020to 26 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18+ receiving hearing aids for the 1st time already have hearing aids fitted able to provide written consent and can complete the simple questionnaire
Who cannot join
- Anyone younger than 18 anyone who does not wear a hearing aid anyone lacking in capacity to provide informed written consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomised Controlled Trial of a Self-Affirmation Theory-Based Intervention to Promote Hearing Aid Use
Hearing aids are the number one treatment for hearing loss and it is estimated that out of the 2 million of UK individuals who are supplied with hearing aids 1.4 million will use their hearing aids to varying degrees and the other 0.6 million will stop using their hearing aids altogether.
The proposed research is looking to improve hearing aid usage by using a self-affirmation intervention which lowers the threat of participants' ageing anxiety. The target of lowering participants' ageing anxiety to improve hearing aid use is because there is a stigma of hearing aids making people seem old and this stigma can make individuals resistant to wearing their hearing aids as they do not want to be seen in this light.
Read more
The current proposed research is an extension of a pilot study that was conducted in 2016 which found that a self-affirmation intervention may be useful in improving individuals' hearing aid usage. They randomly allocated 50 first-time hearing aid users either to a group that undertook a self-affirming exercise (e.g., "If I feel threatened or anxious, then I will think about the things I value about myself") or to a no-intervention control group. Consistent with the idea that self-affirmation helps people deal with threat, first-time hearing aid users reported significantly lower anxieties about ageing after self-affirming. Moreover, according to the data usage downloaded from their hearing aids (data-logging), the self-affirming group were found to have worn their hearing aids an average of two hours per day longer than the control group. Due to the limited number of participants, the effects of the intervention were not statistically significant. Nevertheless, the low cost and high potential public health "reach" alongside the effect size of d = 0.43 indicates that the intervention shows promise.
The main aim of this research is to re-test the self-affirmation intervention from the previous pilot study with a sufficiently large enough sample to answer the following "Does a self-affirmation intervention improve participant's hearing aid usage when compared to participants in the control group?
Read the detailed description
Participants will be recruited through two NHS audiology clinics where they will be invited to participant in this study via an invitation letter either enclosed within their appointment letter or given to them at their audiology appointment. The information used to identify potential participants is that of their diagnoses (must be using or being supplied with hearing aids) . The audiology clinic staff will be identifying potential clients therefore it is believed that there is unlikely to be a breach of confidentiality. All participants will be sent a £10 shop-for-all voucher for participating in the second stage of the study (10-week post appointment) this will be sent to participants home after 6 months and this will include an invitation to a follow up questionnaire.
All prospective participants will be required to give written consent before being assigned to the study and those unable to do this will not be included. After consent is given participants will be allocated to either the intervention group or the control group. Procedure of the proposed study is as follows:
- Each participant will be randomly assigned to either the control group or the intervention group. Blinding of both the participant and the researcher with regards to which group the participant has been assigned to will be achieved by all questionnaires being placed in opaque envelopes which will have a number printed on the front of the envelope. The numbers from the envelope will be placed in a computerised list generator and an order list of how they are to be administered will be produced. Alternatively participants can go online and the platform will randomly assign them to either the intervention or the control questionnaire.
- Participants in both groups fill in a questionnaire which contain the following Scales: The Anxiety toward Ageing Scale (AAS), The Attitudes Toward Loss of Hearing Questionnaire (ATLH) and The Glasgow Benefit Hearing Aid Scale (GBHA) as well as a self-report question on their daily hearing aid use. The intervention group also undertake a self-affirmation exercise which is placed at the end of the questionnaire. This is expected to take 20-30 minutes.
- Participants return 10 weeks later (post) and have their hearing aid usage downloaded (hours per day the aids were worn) from their hearing aids by an audiologist before subsequently filling in another questionnaire which again contains the AAS, ATLH, GBHA and a self- report question on their daily hearing aid use. This is expected to take 30-40 minutes.
3A: If it is not possible for the participant to come back for a follow up appointment the second questionnaire will be sent out postal to the participants address or an email with a hyperlink to the follow up questionnaire online will be sent to participants who previously completed the first questionnaire online.
4: Six months later participants are contacted via email ( hyperlink) or post to fill in an optional questionnaire containing the AAS, ATLH, GBHA and a self-report question on their daily hearing aid use which they send back to the researcher. This should take 20-30 minutes. If participants receive the follow up questionnaire through the post the shopping voucher will also be enclosed. Online participants will also receive their shopping voucher through the post.
5: A debrief form will be sent out via e-mail or post by the principal researcher 3 weeks after the follow up questionnaire was returned or alternatively if they decide to not to complete the follow up questionnaire the debrief will be sent 4 weeks after the initial questionnaire request was sent.
A G-power analysis was conducted to detect a small-moderate effect size (Cohen's D of 0.35) with 80% power at the 5% significance level which indicated that a sample of 260 participants (130 per group) would be required. This study will attempt to recruit 400 based on a similar pilot study having a 34% attrition rate. The data collection phase will continue until 260 participants have completed the 10 week follow up.
The study design is a mixed Design: Between-participants factor is condition (control vs intervention). Within-participants factor is time (pre-intervention vs post intervention (10-week) vs exit (6 month after post ). We will use a series of 2 (Intervention, control) x 3 ( pre-intervention, post intervention and exit) repeated ANOVA to assess to assess the outcome measures. If a small-moderate effect size (Cohen's d = 0.35) is found on any of the principle and secondary measures, then the Hayes PROCESS macro will be used to examine the possible mediating effects of the intervention on participants' hearing aid usage. If data is missing at the 10-week follow up the participant concerned will be excluded from the analysis at this point. The present study also has a longitudinal element and attrition at 6 months is expected. Any missing data will be addressed by using the "last observation carried forward technique".
All data such as contact details and ethnicity will be pseudonymised and kept in a separate, password protected file, in a restricted access folder on a secure University server. All paper copies of contact details and questionnaire data will be secured in Manchester University in a locked filing cabinet. Only the study team and regulatory monitoring and auditing authorities from the University of Manchester will have access to this data.
All the questionnaire data will be anonymised and kept in a separate, password protected file, in a restricted access folder on a secure University server. Only the study team and regulatory monitoring and auditing authorities from the University of Manchester will have access to this data.
The physical personal data copies will be kept until completion of the study then will be destroyed in accordance with University of Manchester regulations. All consent forms and questionnaire data are deemed as essential and this will be kept for 5 years to comply with University of Manchester regulations.
The current study will go through ethics approval with the National Health Service, Health Research Authority in the UK before it will be allowed to proceed. The study has already been through a preliminary ethics review at the University of Manchester.
- Conditions
- Hearing Loss, Functional
- Being tested
- Self-Affirmation Exercise, Control
- Medical subject headings
- Hearing Loss, Functional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Affirmation ExerciseBehavioural
The self affirming exercise is as follow:
The beginning to a sentence appears below. Below it are 4 different ways of completing the sentence. On the lines provided, please write out the beginning of the sentence and then complete it with 1 of the 4 options we have given you.
If I feel threatened or anxious, then I will …………………………………..
Options are as follows:
think about the things I value about myself, remember things that I have succeeded in, think about what I stand for or think about things that are important to me
ControlBehavioural
Given a questionnaire minus the self affirming exercise
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Given the associated questionnaire which has the embedded self-affirmation exercise. Receives: Behavioral: Self-Affirmation Exercise |
| Control | Active comparator | Given the associated questionnaire without the embedded self-affirmation exercise. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing aid usage data from participants hearing aids
The daily use of participants hearing aid use is pulled from their hearing aids data logging
Measured: At the 10 weeks after baseline is taken
Secondary outcomes (4)
Participants self-reported measure of hearing aid use.
Measured by asking participants "Thinking about how much you used your present hearing aid(s) over the past two weeks. On an average day, how many hours did you think you used the hearing aid(s)?"
Measured: Baseline pre-intervention: 10 weeks after baseline: 34 weeks after baseline.
Participants Anxiety toward Aging
Will be measured by using The Anxiety Towards Ageing Scale (AAS; Lasher \& faulkender,1993) this is a 20-question questionnaire. An example of the questions included is: "I expect to feel good about life when I am old" it is measured on a 7-point Likert scale 1= strongly disagree to 7= strongly agree.
Measured: Baseline pre-intervention: 10 weeks after baseline: 34 weeks after baseline.
Participants hearing loss/aid stigma.
Will be measure using the subscale of "negative associations" from The Attitudes towards Loss of Hearing Questionnaire (Saunders \& Cienkowski, 1996) there are 4 questions within this subscale an example is: "The thought of wearing a hearing aid makes me feel older." It is measured on a 7-point Likert scale 1= strongly disagree to 7= strongly agree.
Measured: Baseline pre-intervention: 10 weeks after baseline: 34 weeks after baseline.
Participants perceived benefit / satisfaction participants have for their hearing aids
Will be measured by using the 4 standard questions presented on The Glasgow Benefit Hearing Aid scale (Gatehouse \& Browning,1996). An example of these questions is "Please think about listening to the television with other family members or friends when the volume is adjusted to suit other people. Over the past two weeks, how much difficulty do you have in this situation?" It is answered on a 6-Likert scale 1= not applicable 2= Not at all and 6= Very much indeed.
Measured: Baseline pre-intervention: 10 weeks after baseline: 34 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start5 Oct 2020 (estimated)
- Primary completion20 Dec 2021 (estimated)
- Study completion26 Sep 2022 (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 Hearing Loss, FunctionalStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to an intervention which is a questionnaire based with a self-affirmation embedded at the end of the questionnaire or they are assigned to a control group who undertake the same questionnaire minus the self-affirmation exercise.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerry Ware, University of Manchester
- Investigators
- Kerry Ware, Principal investigator, The University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382703
- Sponsor's protocol ID
- 274086
- Other IDs
- IS-BRC-1215-20007
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armitage CJ, Lees D, Lewis K, Munro KJ. Preliminary support for a brief psychological intervention to improve first-time hearing aid use among adults. Br J Health Psychol. 2017 Nov;22(4):686-700. doi: 10.1111/bjhp.12244. Epub 2017 May 9.
PubMed 28485483Overall, J. E., Tonidandel, S., & Starbuck, R. R. (2009). Last-observation-carried-forward (LOCF) and tests for difference in mean rates of change in controlled repeated measurements designs with dropouts. Social Science Research, 38(2), 492-503.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of a Self-Affirmation Theory-Based Intervention to Promote Hearing Aid Use
- ClinicalTrials.gov ID
- NCT04382703
- Acronym / sponsor ID
- 274086
- Conditions
- Hearing Loss, Functional
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 5 Oct 2020 (estimated)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 26 Sep 2022 (estimated)
- First posted
- 11 May 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.
Hearing aids are the number one treatment for hearing loss and it is estimated that out of the 2 million of UK individuals who are supplied with hearing aids 1.4 million will use their hearing aids to varying degrees and the other 0.6 million will stop using their hearing aids altogether.
The proposed research is looking to improve hearing aid usage by using a self-affirmation intervention which lowers the threat of participants' ageing anxiety. The target of lowering participants' ageing anxiety to improve hearing aid use is because there is a stigma of hearing aids making people seem old and this stigma can make individuals resistant to wearing their hearing aids as they do not want to be seen in this light.
The current proposed research is an extension of a pilot study that was conducted in 2016 which found that a self-affirmation intervention may be useful in improving individuals' hearing aid usage. They randomly allocated 50 first-time hearing aid users either to a group that undertook a self-affirming exercise (e.g., "If I feel threatened or anxious, then I will think about the things I value about myself") or to a no-intervention control group. Consistent with the idea that self-affirmation helps people deal with threat, first-time hearing aid users reported significantly lower anxieties about ageing after self-affirming. Moreover, according to the data usage downloaded from their hearing aids (data-logging), the self-affirming group were found to have worn their hearing aids an average of two hours per day longer than the control group. Due to the limited number of participants, the effects of the intervention were not statistically significant. Nevertheless, the low cost and high potential public health "reach" alongside the effect size of d = 0.43 indicates that the intervention shows promise.
The main aim of this research is to re-test the self-affirmation intervention from the previous pilot study with a sufficiently large enough sample to answer the following "Does a self-affirmation intervention improve participant's hearing aid usage when compared to participants in the control group?
Detailed description
Participants will be recruited through two NHS audiology clinics where they will be invited to participant in this study via an invitation letter either enclosed within their appointment letter or given to them at their audiology appointment. The information used to identify potential participants is that of their diagnoses (must be using or being supplied with hearing aids) . The audiology clinic staff will be identifying potential clients therefore it is believed that there is unlikely to be a breach of confidentiality. All participants will be sent a £10 shop-for-all voucher for participating in the second stage of the study (10-week post appointment) this will be sent to participants home after 6 months and this will include an invitation to a follow up questionnaire.
All prospective participants will be required to give written consent before being assigned to the study and those unable to do this will not be included. After consent is given participants will be allocated to either the intervention group or the control group. Procedure of the proposed study is as follows:
- Each participant will be randomly assigned to either the control group or the intervention group. Blinding of both the participant and the researcher with regards to which group the participant has been assigned to will be achieved by all questionnaires being placed in opaque envelopes which will have a number printed on the front of the envelope. The numbers from the envelope will be placed in a computerised list generator and an order list of how they are to be administered will be produced. Alternatively participants can go online and the platform will randomly assign them to either the intervention or the control questionnaire.
- Participants in both groups fill in a questionnaire which contain the following Scales: The Anxiety toward Ageing Scale (AAS), The Attitudes Toward Loss of Hearing Questionnaire (ATLH) and The Glasgow Benefit Hearing Aid Scale (GBHA) as well as a self-report question on their daily hearing aid use. The intervention group also undertake a self-affirmation exercise which is placed at the end of the questionnaire. This is expected to take 20-30 minutes.
- Participants return 10 weeks later (post) and have their hearing aid usage downloaded (hours per day the aids were worn) from their hearing aids by an audiologist before subsequently filling in another questionnaire which again contains the AAS, ATLH, GBHA and a self- report question on their daily hearing aid use. This is expected to take 30-40 minutes.
3A: If it is not possible for the participant to come back for a follow up appointment the second questionnaire will be sent out postal to the participants address or an email with a hyperlink to the follow up questionnaire online will be sent to participants who previously completed the first questionnaire online.
4: Six months later participants are contacted via email ( hyperlink) or post to fill in an optional questionnaire containing the AAS, ATLH, GBHA and a self-report question on their daily hearing aid use which they send back to the researcher. This should take 20-30 minutes. If participants receive the follow up questionnaire through the post the shopping voucher will also be enclosed. Online participants will also receive their shopping voucher through the post.
5: A debrief form will be sent out via e-mail or post by the principal researcher 3 weeks after the follow up questionnaire was returned or alternatively if they decide to not to complete the follow up questionnaire the debrief will be sent 4 weeks after the initial questionnaire request was sent.
A G-power analysis was conducted to detect a small-moderate effect size (Cohen's D of 0.35) with 80% power at the 5% significance level which indicated that a sample of 260 participants (130 per group) would be required. This study will attempt to recruit 400 based on a similar pilot study having a 34% attrition rate. The data collection phase will continue until 260 participants have completed the 10 week follow up.
The study design is a mixed Design: Between-participants factor is condition (control vs intervention). Within-participants factor is time (pre-intervention vs post intervention (10-week) vs exit (6 month after post ). We will use a series of 2 (Intervention, control) x 3 ( pre-intervention, post intervention and exit) repeated ANOVA to assess to assess the outcome measures. If a small-moderate effect size (Cohen's d = 0.35) is found on any of the principle and secondary measures, then the Hayes PROCESS macro will be used to examine the possible mediating effects of the intervention on participants' hearing aid usage. If data is missing at the 10-week follow up the participant concerned will be excluded from the analysis at this point. The present study also has a longitudinal element and attrition at 6 months is expected. Any missing data will be addressed by using the "last observation carried forward technique".
All data such as contact details and ethnicity will be pseudonymised and kept in a separate, password protected file, in a restricted access folder on a secure University server. All paper copies of contact details and questionnaire data will be secured in Manchester University in a locked filing cabinet. Only the study team and regulatory monitoring and auditing authorities from the University of Manchester will have access to this data.
All the questionnaire data will be anonymised and kept in a separate, password protected file, in a restricted access folder on a secure University server. Only the study team and regulatory monitoring and auditing authorities from the University of Manchester will have access to this data.
The physical personal data copies will be kept until completion of the study then will be destroyed in accordance with University of Manchester regulations. All consent forms and questionnaire data are deemed as essential and this will be kept for 5 years to comply with University of Manchester regulations.
The current study will go through ethics approval with the National Health Service, Health Research Authority in the UK before it will be allowed to proceed. The study has already been through a preliminary ethics review at the University of Manchester.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to an intervention which is a questionnaire based with a self-affirmation embedded at the end of the questionnaire or they are assigned to a control group who undertake the same questionnaire minus the self-affirmation exercise.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Self-Affirmation ExerciseGiven the associated questionnaire which has the embedded self-affirmation exercise. |
| Control | Active comparator | Behavioral: ControlGiven the associated questionnaire without the embedded self-affirmation exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults 18+ receiving hearing aids for the 1st time already have hearing aids fitted able to provide written consent and can complete the simple questionnaire
Key exclusion criteria (1 listed)
- Anyone younger than 18 anyone who does not wear a hearing aid anyone lacking in capacity to provide informed written 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 |
|---|---|---|
| Self-Affirmation ExerciseThe self affirming exercise is as follow: The beginning to a sentence appears below. Below it are 4 different ways of completing the sentence. On the lines provided, please write out the beginning of the sentence and then complete it with 1 of the 4 options we have given you. If I feel threatened or anxious, then I will ………………………………….. Options are as follows: think about the things I value about myself, remember things that I have succeeded in, think about what I stand for or think about things that are important to me | Behavioural | Intervention |
| ControlGiven a questionnaire minus the self affirming exercise | Behavioural | Control |
Primary outcome
Hearing aid usage data from participants hearing aids
Time frame: At the 10 weeks after baseline is taken
The daily use of participants hearing aid use is pulled from their hearing aids data logging
4 secondary outcomes
Participants self-reported measure of hearing aid use.
Time frame: Baseline pre-intervention: 10 weeks after baseline: 34 weeks after baseline.
Participants Anxiety toward Aging
Time frame: Baseline pre-intervention: 10 weeks after baseline: 34 weeks after baseline.
Participants hearing loss/aid stigma.
Time frame: Baseline pre-intervention: 10 weeks after baseline: 34 weeks after baseline.
Participants perceived benefit / satisfaction participants have for their hearing aids
Time frame: Baseline pre-intervention: 10 weeks after baseline: 34 weeks after baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 28485483Armitage CJ, Lees D, Lewis K, Munro KJ. Preliminary support for a brief psychological intervention to improve first-time hearing aid use among adults. Br J Health Psychol. 2017 Nov;22(4):686-700. doi: 10.1111/bjhp.12244. Epub 2017 May 9.
- BackgroundOverall, J. E., Tonidandel, S., & Starbuck, R. R. (2009). Last-observation-carried-forward (LOCF) and tests for difference in mean rates of change in controlled repeated measurements designs with dropouts. Social Science Research, 38(2), 492-503.
- 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.
Kerry Ware principal investigator
The University of Manchester
Questions about this trial
What is this clinical trial studying?
A study testing Self-Affirmation Exercise in people with Hearing Loss, Functional, run by University of Manchester.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ware (07931804663, kerry.ware-2@postgrad.manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing aid usage data from participants hearing aids (time frame: At the 10 weeks after baseline is taken). 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 NCT04382703, 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 16 Sep 2020; AzTrials last refreshed its copy on 30 Oct 2026.