Vision; Disorder, LossNCT04583748

Virtual Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers

A study testing Sahaj Samadhi Meditation and Health Enhancement Program in people with Vision; Disorder, Loss and Caregiver Burnout, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Vision loss is common among older adults and leads to an increased risk for depression and difficulties in daily tasks, thus requiring dependence on caregivers. This study will assess the feasibility of providing two virtual interventions, Sahaj Samadhi Meditation (SSM) and Health Enhancement Program (HEP), to… Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Vision; Disorder, Loss, Caregiver Burnout, Quality of Life
What is being tested?: Sahaj Samadhi Meditation and Health Enhancement Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Apr 2022to 9 Apr 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 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients diagnosed with irreversible age-related vision loss (IARVL) by an experienced ophthalmologist and/or their caregivers.
IARVL patients between the age range of 60 to 85 years, while caregivers between the age range of 18 to 85 years.
Be able to provide valid informed consent to participate in the research study.
Being able to speak as well as understand English without the requirement for interpretation or other communication assistance.
Having no significant self-reported or a physician-diagnosed mental health disorder other than depressive and/or anxiety symptoms.
Should reach a minimal threshold of depressive and/or anxiety symptoms as confirmed by either a minimum of Centre for Epidemiologic Studies - Depression (CES-D) 20-item scale score of 16 OR a minimum of 8 on the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A).

Show all 10Show fewer

Have sufficient hearing to be able to follow verbal instructions
Have the ability to sit independently without physical discomfort for 30 minutes.
Willing and able to attend virtual intervention via Cisco WebEx software, the four initial training sessions of SSM or HEP and at least 6 out of 11 weekly follow-up sessions.
Willing to dedicate 20 minutes twice per day six days per week to their assigned home practice.

Who cannot join

Inability to provide a valid informed consent.
Having an underlying major neurocognitive disorder as suggested by a Montreal Cognitive Assessment (MoCA) score < 21.
Having significant suicidal ideation as per self-report (CES-D = 3 on item question 14 and/or 15).
Having severe depression as confirmed by a CES-D ≥ 24.
Participating in other similar studies.
Having a lifetime diagnosis of self-reported other serious mental disorders, including bipolar I or II disorder, primary psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder).

Show all 10Show fewer

Self-reported substance abuse or dependence within the past 3 months.
Having an acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.
Having a terminal medical diagnosis with prognosis of less than 12 months.
Having any planned changes to mood-altering medications at the time of enrollment for the next 12 weeks.

About this study

Official title: Virtual Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers: A Pilot Randomized Controlled Trial

Read the detailed description

Through a high-quality, single-blind, three-arm mixed-method pilot feasibility study using randomized treatment assignment, the study team will assess two new innovative interventions, Sahaj Samadhi Meditation (SSM) and Health Enhancement Program (HEP), both delivered virtually, to augment clinical care of patients with irreversible age-related vision loss (IARVL), with the goal of enhancing mental health and quality of life (QOL) for patients and/or their caregivers. Participants will be blinded to the treatment hypothesis, while investigators and treating clinicians will be additionally blinded to the intervention. Both SSM and HEP will be taught over 4 consecutive days in similar sized groups (10 patients and/or their 10 caregivers) followed by weekly reinforcement sessions for subsequent 11 weeks. Self-rated questionnaires will be used to collect data on quality of life and mental health symptoms at 0-week and 12-week follow-up

Conditions: Vision; Disorder, Loss, Caregiver Burnout, Quality of Life, Depression, Anxiety, Sleep
Being tested: Sahaj Samadhi Meditation, Health Enhancement Program
Keywords: Irreversible Age-Related Vision Loss, Caregivers, Quality of Life, Mental Health, Depression, Anxiety, Sleep Quality, Community Integration, Resilience, Caregiver Burden, Sahaj Samadhi Meditation, Health Enhancement Program, Virtual
Medical subject headings: Caregiver Burden, Depression, Anxiety Disorders, Psychological Well-Being, Sleep Initiation and Maintenance Disorders

What participants receive

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

Sahaj Samadhi MeditationBehavioural
Also called SSM
Sahaj Samadhi Meditation (SSM) is a form of automatic self-transcending meditation that involves relaxed attention to a precise sound (mantra), to allow stress reduction and deep relaxation. This technique is easy to learn and offers the support of a group and facilitator.
Health Enhancement ProgramBehavioural
Also called HEP
The Health Enhancement Program (HEP) is a standardized program used to teach participants about health promotion, including the benefits of a lifestyle of healthy diet, music, recreation, and exercise. In HEP, participants get the support of a group and facilitator, and talk through and try to implement positive health-enhancing life changes.

Study groups in NCT04583748
Study group	Role	What they receive
Sahaj Samadhi Meditation	Experimental	Participants randomized to the Sahaj Samadhi Meditation (SSM) arm will undergo SSM training in groups of 10. SSM will be delivered virtually using the Cisco WebEx platform by trained, certified non-clinician teachers. Participants will be trained for 4 consecutive days (2 hours/day) in the first week, followed by 1-hour weekly reinforcement sessions for 11 weeks. Participants will also be encouraged to practice twice daily at home for 20 minutes per session. They will be given a daily practice log on which they check off a box indicating if they have done their home practice. Receives: Behavioral: Sahaj Samadhi Meditation
Health Enhancement Program	Active comparator	Participants randomized to the Health Enhancement Program (HEP) arm will undergo HEP training in groups of 10. HEP will be delivered virtually using the Cisco WebEx platform by trained non-clinician teachers. Participants will be trained for 4 consecutive days (2 hours/day) in the first week, followed by 1-hour weekly reinforcement sessions for 11 weeks. Participants will also be encouraged to practice twice daily at home for 20 minutes per session. They will be given a daily practice log on which they check off a box indicating if they have done their home practice. Receives: Behavioral: Health Enhancement Program
Treatment as Usual	No intervention	Participants randomized to the Treatment as Usual (TAU) arm will continue to receive their treatment as usual. The usual standard of care for irreversible age-related vision patients includes no active treatment since eye surgeons have done all that could possibly be done to restore vision.

What is being measured

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

Number of Potential Participants Approached Per Month
The number of potential participants approached per month will be calculated as a feasibility measure.
Measured: 1 year
Number of Participants who are Successfully Screened
The number of participants who are successfully screened will be calculated as a feasibility measure.
Measured: 1 year
Proportion of Successfully Screened in Participants who Enroll
The proportion of successfully screened in participants who enroll in the study will be calculated as a feasibility measure.
Measured: 1 year
Rate of Retention
The rate of retention of participants in the study will be calculated as a feasibility measure.
Measured: 1 year
Rate of Adherence to Study Protocol
At the end of the study any deviations from the protocol will be examined to determine the rate of adherence to the study protocol. This information will be calculated as a feasibility measure.
Measured: 1 year
Proportion of Planned Ratings that are Completed
The proportion of completed planned ratings will be calculated as a feasibility measure.
Measured: 1 year
Intervention Cost Per Case
The cost per participant of attending the SSM program will be calculated as a feasibility measure.
Measured: 1 year
Percentage of Time Trade-Off (TTO) Questionnaires Completed
The percentage of TTO questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Measured: 1 year
Percentage of Visual Function Index (VF-14) Questionnaires Completed
The percentage of VF-14 questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Measured: 1 year
Percentage of Center for Epidemiologic Studies - Depression (CES-D) Questionnaires Completed
The percentage of CES-D questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Measured: 1 year
Percentage of Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Questionnaires Completed
The percentage of HADS-A questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Measured: 1 year
Percentage of Pittsburgh Sleep Quality Index (PSQI) Questionnaires Completed
The percentage of PSQI questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Measured: 1 year
Percentage of Community Integration Questionnaire (CIQ) Questionnaires Completed
The percentage of CIQ questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Measured: 1 year
Percentage of Connor-Davidson Resilience Scale (CD-RISC) Questionnaires Completed
The percentage of CD-RISC questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Measured: 1 year
Percentage of Zarit Burden Interview (ZBI) Questionnaires Completed
The percentage of ZBI questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Measured: 1 year

Secondary outcomes (8)

Change in Health-Related Quality of Life Score
Change in Health-Related Quality of Life (HRQOL) score as measured by the Time Trade-Off questionnaire (TTO) over a 12-week follow-up. TTO scores range between 0 and 1, with higher scores indicating a higher quality of life.
Measured: Weeks 0 and 12
Change in Vision-Related Quality of Life Score
Change in Vision-Related Quality of Life (VRQOL) score as measured by the Visual Function Index questionnaire (VF-14) over a 12-week follow-up. VF-14 scores range from 0 to 100, with higher scores representing a greater VRQOL.
Measured: Weeks 0 and 12
Change in Depressive Symptoms
Change in depressive symptoms as measured by change in Center for Epidemiologic Studies - Depression (CES-D) scores over a 12-week follow-up. The possible range of CES-D scores is 0 to 60, with the higher scores indicating the presence of more depressive symptomatology.
Measured: Weeks 0 and 12
Change in Anxiety Symptoms
Change in anxiety symptoms as measured by change in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) scores over a 12-week follow-up. Total scores on the HADS-A range from 0 to 21. Higher scores represent higher levels of psychological distress.
Measured: Weeks 0 and 12
Change in Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
Change in sleep quality as measured by change in Pittsburgh Sleep Quality Index (PSQI) scores over a 12-week follow-up. PSQI scores range from 0 to 21. Higher PSQI scores indicate worse sleep quality.
Measured: Weeks 0 and 12
Change in Community Integration
Change in community integration as measured by change in Community Integration Questionnaire (CIQ) scores over a 12-week follow-up. The overall score for the CIQ ranges from 0 to 29. Higher CIQ score represents greater integration.
Measured: Weeks 0 and 12
Change in Resilience
Change in resilience as measured by change in Connor-Davidson Resilience Scale (CD-RISC) scores over a 12-week follow-up. Total scores for the CD-RISC range from 0 to 40, with higher scores representing greater resilience.
Measured: Weeks 0 and 12
Change in Caregiver Burden
Change in caregiver burden as measured by change in Zarit Burden Interview (ZBI) scores over a 12-week follow-up. Total scores for the ZBI range from 0 to 88. Higher scores represent a more severe self-perceived burden of caregiving.
Measured: Weeks 0 and 12

Timeline

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

Apr 20229 Apr 2022

First posted12 Oct 2020
Study startApr 2022 (estimated)
Primary completion9 Apr 2022
Study completion9 Apr 2022

Why it stopped: COVID 19

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Vision; Disorder, LossStudies of the same condition, open and under way.
More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients will undergo 1:1:1 randomization to Sahaj Samadhi Meditation or Health Enhancement Program or Treatment as Usual, stratified by gender. Twenty-five irreversible age-related vision loss patients and their 25 caregivers will be assigned, on a rolling basis, in the three groups.
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04583748
Sponsor's protocol ID: 4860
Status last verified: Apr 2022
First submitted: 21 Sep 2020
Last updated: 18 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

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

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

Questions to ask the study team

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

Official record

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All Vision; Disorder, Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Virtual Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers: A Pilot Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04583748
Acronym / sponsor ID: 4860
Conditions: Vision; Disorder, Loss, Caregiver Burnout, Quality of Life, Depression, Anxiety, Sleep
Keywords: Irreversible Age-Related Vision Loss, Caregivers, Quality of Life, Mental Health, Depression, Anxiety, Sleep Quality, Community Integration
Study type: Interventional
Recruitment status: WithdrawnReason stopped: COVID 19
Enrolment: 0 participants (actual)
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
Collaborators: The Art of Living Foundation
Study start: Apr 2022 (estimated)
Primary completion: 9 Apr 2022 (actual)
Study completion: 9 Apr 2022 (actual)
First posted: 12 Oct 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3
Model description: Patients will undergo 1:1:1 randomization to Sahaj Samadhi Meditation or Health Enhancement Program or Treatment as Usual, stratified by gender. Twenty-five irreversible age-related vision loss patients and their 25 caregivers will be assigned, on a rolling basis, in the three groups.

Arm	Type	Receives
Sahaj Samadhi Meditation	Experimental	Behavioral: Sahaj Samadhi MeditationParticipants randomized to the Sahaj Samadhi Meditation (SSM) arm will undergo SSM training in groups of 10. SSM will be delivered virtually using the Cisco WebEx platform by trained, certified non-clinician teachers. Participants will be trained for 4 consecutive days (2 hours/day) in the first week, followed by 1-hour weekly reinforcement sessions for 11 weeks. Participants will also be encouraged to practice twice daily at home for 20 minutes per session. They will be given a daily practice log on which they check off a box indicating if they have done their home practice.
Health Enhancement Program	Active comparator	Behavioral: Health Enhancement ProgramParticipants randomized to the Health Enhancement Program (HEP) arm will undergo HEP training in groups of 10. HEP will be delivered virtually using the Cisco WebEx platform by trained non-clinician teachers. Participants will be trained for 4 consecutive days (2 hours/day) in the first week, followed by 1-hour weekly reinforcement sessions for 11 weeks. Participants will also be encouraged to practice twice daily at home for 20 minutes per session. They will be given a daily practice log on which they check off a box indicating if they have done their home practice.
Treatment as Usual	No intervention	–Participants randomized to the Treatment as Usual (TAU) arm will continue to receive their treatment as usual. The usual standard of care for irreversible age-related vision patients includes no active treatment since eye surgeons have done all that could possibly be done to restore vision.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Patients diagnosed with irreversible age-related vision loss (IARVL) by an experienced ophthalmologist and/or their caregivers.
IARVL patients between the age range of 60 to 85 years, while caregivers between the age range of 18 to 85 years.
Be able to provide valid informed consent to participate in the research study.
Being able to speak as well as understand English without the requirement for interpretation or other communication assistance.
Having no significant self-reported or a physician-diagnosed mental health disorder other than depressive and/or anxiety symptoms.

Key exclusion criteria (10 listed)

Inability to provide a valid informed consent.
Having an underlying major neurocognitive disorder as suggested by a Montreal Cognitive Assessment (MoCA) score < 21.
Having significant suicidal ideation as per self-report (CES-D = 3 on item question 14 and/or 15).
Having severe depression as confirmed by a CES-D ≥ 24.
Participating in other similar studies.

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
Sahaj Samadhi MeditationAlso: SSMSahaj Samadhi Meditation (SSM) is a form of automatic self-transcending meditation that involves relaxed attention to a precise sound (mantra), to allow stress reduction and deep relaxation. This technique is easy to learn and offers the support of a group and facilitator.	Behavioural	Sahaj Samadhi Meditation
Health Enhancement ProgramAlso: HEPThe Health Enhancement Program (HEP) is a standardized program used to teach participants about health promotion, including the benefits of a lifestyle of healthy diet, music, recreation, and exercise. In HEP, participants get the support of a group and facilitator, and talk through and try to implement positive health-enhancing life changes.	Behavioural	Health Enhancement Program

Primary outcome

Number of Potential Participants Approached Per Month
Time frame: 1 year
The number of potential participants approached per month will be calculated as a feasibility measure.
Number of Participants who are Successfully Screened
Time frame: 1 year
The number of participants who are successfully screened will be calculated as a feasibility measure.
Proportion of Successfully Screened in Participants who Enroll
Time frame: 1 year
The proportion of successfully screened in participants who enroll in the study will be calculated as a feasibility measure.
Rate of Retention
Time frame: 1 year
The rate of retention of participants in the study will be calculated as a feasibility measure.
Rate of Adherence to Study Protocol
Time frame: 1 year
At the end of the study any deviations from the protocol will be examined to determine the rate of adherence to the study protocol. This information will be calculated as a feasibility measure.
Proportion of Planned Ratings that are Completed
Time frame: 1 year
The proportion of completed planned ratings will be calculated as a feasibility measure.
Intervention Cost Per Case
Time frame: 1 year
The cost per participant of attending the SSM program will be calculated as a feasibility measure.
Percentage of Time Trade-Off (TTO) Questionnaires Completed
Time frame: 1 year
The percentage of TTO questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Visual Function Index (VF-14) Questionnaires Completed
Time frame: 1 year
The percentage of VF-14 questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Center for Epidemiologic Studies - Depression (CES-D) Questionnaires Completed
Time frame: 1 year
The percentage of CES-D questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Questionnaires Completed
Time frame: 1 year
The percentage of HADS-A questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Pittsburgh Sleep Quality Index (PSQI) Questionnaires Completed
Time frame: 1 year
The percentage of PSQI questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Community Integration Questionnaire (CIQ) Questionnaires Completed
Time frame: 1 year
The percentage of CIQ questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Connor-Davidson Resilience Scale (CD-RISC) Questionnaires Completed
Time frame: 1 year
The percentage of CD-RISC questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.
Percentage of Zarit Burden Interview (ZBI) Questionnaires Completed
Time frame: 1 year
The percentage of ZBI questionnaires completed by each participant will be examined at the end of the study to assess the completeness of the data as a feasibility measure.

8 secondary outcomes

Change in Health-Related Quality of Life Score
Time frame: Weeks 0 and 12
Change in Vision-Related Quality of Life Score
Time frame: Weeks 0 and 12
Change in Depressive Symptoms
Time frame: Weeks 0 and 12
Change in Anxiety Symptoms
Time frame: Weeks 0 and 12
Change in Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
Time frame: Weeks 0 and 12
Change in Community Integration
Time frame: Weeks 0 and 12
Change in Resilience
Time frame: Weeks 0 and 12
Change in Caregiver Burden
Time frame: Weeks 0 and 12

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
Individual participant dataSharing planned: No

Related trials for Vision; Disorder, Loss

Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Active, not recruitingPhase 4
A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration
Geographic Atrophy, Age-Related Macular Degeneration
Not yet recruiting
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Cortical Blindness
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss

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.

Akshya Vasudev, MD principal investigator

London Health Sciences Centre

Cindy Hutnik, MD, PhD principal investigator

St. Joseph's Healthcare London

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 10 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: withdrawn, as of the sponsor's last update on 18 Apr 2022. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Number of Potential Participants Approached Per Month (time frame: 1 year). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04583748.

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 Apr 2022.