AgingNCT03397836
Health TAPESTRY Ontario
A study testing Health TAPESTRY Intervention in people with Aging, run by McMaster University at 1 site in Canada.
Trial summary
The Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) is a community-based program led by primary care teams, that creates connections between trained community volunteers, interprofessional health care teams, novel technology and community engagement through improved system… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Health TAPESTRY Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 599 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2018to 29 Oct 2020
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Participant Inclusion Criteria:
- Be 70 years of age or older
- Rostered to a participating family physician
Participant Exclusion Criteria:
- They are expected to die within 12 months
- They live in a long-term care facility
- They (or their caregiver) are unable to speak and understand English
- They have other conditions or circumstances that means the patient is unable to engage with the volunteers or complete the TAP-App (e.g., severe dementia)
- They are out of the country for more than 6 months or otherwise unavailable for the intervention and assessments
- Participated in Health TAPESTRY phase I implementation (for Hamilton site)
Site Inclusion Criteria:
A Health TAPESTRY site must have the commitment and capacity to implement and sustain the full Health TAPESTRY Program (all four parts). As such, the following success factors are essential:
- A strong Lead Organization with a clearly identified Health TAPESTRY Practice Model Champion from primary care;
- Visible and influential primary care partner in governance and implementation;
- Team-based use of an electronic system for documentation;
- Primary care team available to provide core of implementation;
- Available Information Technology capacity and commitment to integrate with TAP-App (minimum HL7 document transfer capability) and kindred PHR within 6-9 months of program start date;
- Volunteer infrastructure that can recruit, train, sustain, and coordinate/schedule volunteers, and ensure volunteers have access to the digital health tools needed to fulfill role;
- Existing partnerships with local community services;
- Capacity for local program management either through existing staff or with the addition of new staff;
- Available in-kind resources that can support participation in the Health TAPESTRY Program (e.g., clinician and staff engagement, community engagement, patient engagement, etc.); and
- Commitment to evaluation including, but not limited to, collecting and sharing data from electronic documentation system (based on consent).
Site Exclusion Criteria:
- No functional primary care team linkage to support individual patient or client assessments
- Focused assessment on a single condition or disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health TAPESTRY Ontario: A Randomized Controlled Trial
The Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) is a community-based program led by primary care teams, that creates connections between trained community volunteers, interprofessional health care teams, novel technology and community engagement through improved system navigation. The overall vision is to help people stay healthier for longer in the places where they live.
Read the detailed description
The Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) involves recording a person's life and health goals, screening for health risks and needs, and then initiating a plan that supports achievement of those goals and address risks and needs. It includes four parts:
- Trained volunteers connect with clients (patients) in their home to gather health and social information and discuss and record life and health goals
- Interprofessional health care teams provide health care services to the client and focuses on a plan to support them on meeting their health goals
- Technology is used to collect and share information
- Community engagement connects clients with resources and supports in the community
Initial findings from Implementation Phase I: 6-month unblinded delayed intervention pragmatic randomized controlled trial that took place in Hamilton, ON (HiREB File #14-726, Clinical Trials.gov NCT02283723) showed significant differences between the intervention and control group. Specifically, at 6-months the it was found:
- a reduction in the intervention group versus control group in self-reported time sitting
- an increase in minutes walking in the intervention group versus the control group
- an increase in number of primary care visits in the intervention group versus the control group
- a reduction in odds of people experiencing 1 or more hospitalizations in the intervention group versus the control group
Understanding the feasibility of implementing Health TAPESTRY in other primary care sites is important to evaluate its potential as an approach. Replication of these initial findings are critical in terms of empirical support for the approach as well as spread and scalability in the wider primary health care system.
Six sites have been identified as Health TAPESTRY-Ontario implementation sites. It should be noted that all appropriate site approvals will be obtained prior to implementation.
- Niagara North Family Health Team (Niagara-on-the-Lake) (Mary Keith, executive Lead; Dr. Karen Berti, family health team lead)
- McMaster Family Health Team (Hamilton) (Doug Oliver, family health team lead)
- Superior Family Health Team (Sault Ste Marie) (Michelle Brisbois, executive lead, Dr. Sarah White, family health team lead)
- Dufferin and Area Family Health Team (Dufferin County) (Lianne Barbour, executive Lead, Dr. Mercedes Rodriguez, family health team lead)
- Windsor Family Health Team (Windsor and surrounding area) (Sara Dalo, executive lead)
- Harrow Family Health Team (Harrow and surrounding communities) (Margo Reilly, executive lead, Dr. Alexandra Lindberg, family health team lead)
A broad alliance between Canadian Red Cross and the Department of Family Medicine has been made, with Health TAPESTRY being a part of that alliance. As part of this partnership, the Canadian Red Cross partner will recruit, train, schedule, and retain community volunteers to operate in the 6 sites.
- Conditions
- Aging
- Being tested
- Health TAPESTRY Intervention, Usual Care
- Keywords
- Older adults, Optimal aging, Primary health care, Randomized control trial, Integrated care, Health care volunteers, interdisciplinary health care teams, Implementation, Health services research, Patient centered care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health TAPESTRY InterventionOther
The patient will receive in-home visits from trained volunteers who will collect information electronically using a tablet computer. The volunteers will collect information about the client's health goals, health risks, and needs using a specifically designed application (TAP-App). Once the data is gathered, it is summarized into a report (TAP-report) which is securely and electronically sent to the health care clinic (TAP huddle). The team can leverage clinic supports and/or community supports as they deem appropriate to help clients reach their health goals and address any needs and risks which were reported during the volunteer visits.
Usual CareOther
Usual care while waiting for the Health TAPESTRY intervention, the control group will receive usual care from their healthcare providers.
| Study group | Role | What they receive |
|---|---|---|
| Health TAPESTRY Intervention | Experimental | This patient group will begin receiving the TAPESTRY interventions from time zero Receives: Other: Health TAPESTRY Intervention |
| Usual Care | Active comparator | This patient group will receive the intervention after a 6 month waiting period. In the first 6 months they will receive usual care and they will be used as a comparison group. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hospitalizations
Number of hospitalizations in the past 6 months.
Measured: Change of number of hospitalizations from baseline to 6 months
Change in Physical activity
Physical activity will be measured by the Short version of the International Physical Activity Questionnaire. Respondents indicate how many days in the past seven days and for how many minutes they have engaged in vigorous and moderate intensity activity and walking activity. Scores are calculated by multiplying the days by the number of minutes on one day, by the metabolic equivalent of task (8.0,4.0 and 3.3 for vigorous, moderate, walking activity respectively). Minimum score is of the scale is zero, with higher scores representing higher levels of physical activity.
Measured: Change in physical activity from baseline measurement to 6 months
Secondary outcomes (13)
Emergency department and urgent care visits
Number of emergency department and urgent care visits in the past 6 months. Reasons for each visit will also be extracted in order to describe the nature of visits.
Measured: Baseline, 6 months
Falls
Number of falls in the past 6 months (those resulting in medical treatment).
Measured: Baseline, 6 months
Hours sitting
Hours sitting will be measured by the sitting item on the Short version of the International Physical Activity Questionnaire. Respondents indicate for how many hours they sit in a typical day. Scale ranges from 0 hours to 24 hours, higher scores indicate higher hours sitting.
Measured: Baseline, 6 months
Patient enablement
A modified version of the Patient Enablement Instrument will be used as a measure of patient empowerment in their own care. Specifically, the stem "as a result of your visit to the doctor today…" was deleted and instead, "after a usual visit with your family health care team, do you feel that you are…" was used.
Measured: Baseline, 6 months
Quality of life
The EuroQol five dimension (EQ-5D-5L) will be used to measure quality of life. This survey asks respondents to rate their ability in five different domains: mobility, self-care, usual activities, pain, and anxiety/depression. In addition, respondents are asked to rate their current health state on a scale from 0 ('worst health you can imagine') to 100 ('best health you can imagine'). A score from the five domains is calculated using a macro program and ranges from 0 to 1.
Measured: Baseline, 6 months
Treatment burden
Treatment burden will be measured by the Brief Treatment Burden Scale. Respondents are asked to rate their level of difficulty they have with ten different treatment-related tasks on a scale from "not difficult" to "extremely difficult".
Measured: Baseline, 6 months
Disease burden
Disease burden will be measured using the Disease Burden survey. Respondents are asked to indicate which conditions they have, and for those conditions present, the degree to which the condition hurts their daily activity from "not at all" to "a lot". The list contains common chronic conditions.
Measured: Baseline, 6 months
Medications
Number of long-term prescription medications (defined as use of a medication for 3 or more months).
Measured: Baseline, 6 months
Negative effects (unmet expectations)
A measure of unmet expectations specifically developed for this trial. Participants will be asked to rate the level of their expectation with the question: 'In thinking about the kind and amount of care you received as a result of Health TAPESTRY, to what extent did it meet your expectations?' Answer option include: exceeded expectations, met expectations, no real difference in kind or amount of care received, or kind and amount of care received was worse than before Health TAPESTRY.
Measured: Baseline, 6 months
Negative effects (effects of labeling)
The negative effects of labeling will be measured using a survey developed for this trial. For those identifying that Health TAPESTRY made them aware of health conditions or risks they were unaware of before, an open-ended question to describe the impact of this awareness will be asked.
Measured: 6 months
Negative effects (serious adverse events)
Serious adverse events will be recorded using retrospective chart audit.
Measured: 6 months
Primary care visits
Number of primary care visits.
Measured: Baseline, 6 months
Reason for hospitalization
Reason for each hospitalization will be categorized into ambulatory care sensitive conditions or acute care conditions.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start15 Mar 2018
- Primary completion29 Oct 2020
- Study completion29 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by McMaster 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Red Cross, Ontario Ministry of Health and Long Term Care, David Braley
- Responsible party
- Sponsor
- Investigators
- Dee Mangin, MBChB,DPH,FR, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397836
- Sponsor's protocol ID
- 3967
- Status last verified
- Nov 2020
- First submitted
- 12 Dec 2017
- Last updated
- 10 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mangin D, Lamarche L, Oliver D, Blackhouse G, Bomze S, Borhan S, Carr T, Clark R, Datta J, Dolovich L, Gaber J, Forsyth P, Howard M, Marentette-Brown S, Risdon C, Talat S, Tarride JE, Thabane L, Valaitis R, Price D. Health TAPESTRY Ontario: A Multi-Site Randomized Controlled Trial Testing Implementation and Reproducibility. Ann Fam Med. 2023 Mar-Apr;21(2):132-142. doi: 10.1370/afm.2944.
PubMed 36973055Lamarche L, Clark RE, Parascandalo F, Mangin D. The implementation and validation of the NoMAD during a complex primary care intervention. BMC Med Res Methodol. 2022 Jun 19;22(1):175. doi: 10.1186/s12874-022-01655-0.
PubMed 35718763Gaber J, Datta J, Clark R, Lamarche L, Parascandalo F, Di Pelino S, Forsyth P, Oliver D, Mangin D, Price D. Understanding how context and culture in six communities can shape implementation of a complex intervention: a comparative case study. BMC Health Serv Res. 2022 Feb 17;22(1):221. doi: 10.1186/s12913-022-07615-0.
PubMed 35177040Mangin D, Lamarche L, Oliver D, Bomze S, Borhan S, Browne T, Carr T, Datta J, Dolovich L, Howard M, Marentette-Brown S, Risdon C, Talat S, Tarride JE, Thabane L, Valaitis R, Price D. Health TAPESTRY Ontario: protocol for a randomized controlled trial to test reproducibility and implementation. Trials. 2020 Aug 14;21(1):714. doi: 10.1186/s13063-020-04600-y.
PubMed 32795381
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health TAPESTRY Ontario: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03397836
- Acronym / sponsor ID
- 3967
- Conditions
- Aging
- Keywords
- Older adults, Optimal aging, Primary health care, Randomized control trial, Integrated care, Health care volunteers, interdisciplinary health care teams, Implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Red Cross, Ontario Ministry of Health and Long Term Care, David Braley
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 29 Oct 2020 (actual)
- Study completion
- 29 Oct 2020 (actual)
- First posted
- 12 Jan 2018 (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.
The Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) is a community-based program led by primary care teams, that creates connections between trained community volunteers, interprofessional health care teams, novel technology and community engagement through improved system navigation. The overall vision is to help people stay healthier for longer in the places where they live.
Detailed description
The Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) involves recording a person's life and health goals, screening for health risks and needs, and then initiating a plan that supports achievement of those goals and address risks and needs. It includes four parts:
- Trained volunteers connect with clients (patients) in their home to gather health and social information and discuss and record life and health goals
- Interprofessional health care teams provide health care services to the client and focuses on a plan to support them on meeting their health goals
- Technology is used to collect and share information
- Community engagement connects clients with resources and supports in the community
Initial findings from Implementation Phase I: 6-month unblinded delayed intervention pragmatic randomized controlled trial that took place in Hamilton, ON (HiREB File #14-726, Clinical Trials.gov NCT02283723) showed significant differences between the intervention and control group. Specifically, at 6-months the it was found:
- a reduction in the intervention group versus control group in self-reported time sitting
- an increase in minutes walking in the intervention group versus the control group
- an increase in number of primary care visits in the intervention group versus the control group
- a reduction in odds of people experiencing 1 or more hospitalizations in the intervention group versus the control group
Understanding the feasibility of implementing Health TAPESTRY in other primary care sites is important to evaluate its potential as an approach. Replication of these initial findings are critical in terms of empirical support for the approach as well as spread and scalability in the wider primary health care system.
Six sites have been identified as Health TAPESTRY-Ontario implementation sites. It should be noted that all appropriate site approvals will be obtained prior to implementation.
- Niagara North Family Health Team (Niagara-on-the-Lake) (Mary Keith, executive Lead; Dr. Karen Berti, family health team lead)
- McMaster Family Health Team (Hamilton) (Doug Oliver, family health team lead)
- Superior Family Health Team (Sault Ste Marie) (Michelle Brisbois, executive lead, Dr. Sarah White, family health team lead)
- Dufferin and Area Family Health Team (Dufferin County) (Lianne Barbour, executive Lead, Dr. Mercedes Rodriguez, family health team lead)
- Windsor Family Health Team (Windsor and surrounding area) (Sara Dalo, executive lead)
- Harrow Family Health Team (Harrow and surrounding communities) (Margo Reilly, executive lead, Dr. Alexandra Lindberg, family health team lead)
A broad alliance between Canadian Red Cross and the Department of Family Medicine has been made, with Health TAPESTRY being a part of that alliance. As part of this partnership, the Canadian Red Cross partner will recruit, train, schedule, and retain community volunteers to operate in the 6 sites.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health TAPESTRY Intervention | Experimental | Other: Health TAPESTRY InterventionThis patient group will begin receiving the TAPESTRY interventions from time zero |
| Usual Care | Active comparator | Other: Usual CareThis patient group will receive the intervention after a 6 month waiting period. In the first 6 months they will receive usual care and they will be used as a comparison group. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
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 |
|---|---|---|
| Health TAPESTRY InterventionThe patient will receive in-home visits from trained volunteers who will collect information electronically using a tablet computer. The volunteers will collect information about the client's health goals, health risks, and needs using a specifically designed application (TAP-App). Once the data is gathered, it is summarized into a report (TAP-report) which is securely and electronically sent to the health care clinic (TAP huddle). The team can leverage clinic supports and/or community supports as they deem appropriate to help clients reach their health goals and address any needs and risks which were reported during the volunteer visits. | Other | Health TAPESTRY Intervention |
| Usual CareUsual care while waiting for the Health TAPESTRY intervention, the control group will receive usual care from their healthcare providers. | Other | Usual Care |
Primary outcome
Change in Hospitalizations
Time frame: Change of number of hospitalizations from baseline to 6 months
Number of hospitalizations in the past 6 months.
Change in Physical activity
Time frame: Change in physical activity from baseline measurement to 6 months
Physical activity will be measured by the Short version of the International Physical Activity Questionnaire. Respondents indicate how many days in the past seven days and for how many minutes they have engaged in vigorous and moderate intensity activity and walking activity. Scores are calculated by multiplying the days by the number of minutes on one day, by the metabolic equivalent of task (8.0,4.0 and 3.3 for vigorous, moderate, walking activity respectively). Minimum score is of the scale is zero, with higher scores representing higher levels of physical activity.
13 secondary outcomes
Emergency department and urgent care visits
Time frame: Baseline, 6 months
Falls
Time frame: Baseline, 6 months
Hours sitting
Time frame: Baseline, 6 months
Patient enablement
Time frame: Baseline, 6 months
Quality of life
Time frame: Baseline, 6 months
Treatment burden
Time frame: Baseline, 6 months
Disease burden
Time frame: Baseline, 6 months
Medications
Time frame: Baseline, 6 months
Negative effects (unmet expectations)
Time frame: Baseline, 6 months
Negative effects (effects of labeling)
Time frame: 6 months
Negative effects (serious adverse events)
Time frame: 6 months
Primary care visits
Time frame: Baseline, 6 months
Reason for hospitalization
Time frame: Baseline, 6 months
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 10 Jun 2021.
- Derived from this study: PubMed 36973055Mangin D, Lamarche L, Oliver D, Blackhouse G, Bomze S, Borhan S, Carr T, Clark R, Datta J, Dolovich L, Gaber J, Forsyth P, Howard M, Marentette-Brown S, Risdon C, Talat S, Tarride JE, Thabane L, Valaitis R, Price D. Health TAPESTRY Ontario: A Multi-Site Randomized Controlled Trial Testing Implementation and Reproducibility. Ann Fam Med. 2023 Mar-Apr;21(2):132-142. doi: 10.1370/afm.2944.
- Derived from this study: PubMed 35718763Lamarche L, Clark RE, Parascandalo F, Mangin D. The implementation and validation of the NoMAD during a complex primary care intervention. BMC Med Res Methodol. 2022 Jun 19;22(1):175. doi: 10.1186/s12874-022-01655-0.
- Derived from this study: PubMed 35177040Gaber J, Datta J, Clark R, Lamarche L, Parascandalo F, Di Pelino S, Forsyth P, Oliver D, Mangin D, Price D. Understanding how context and culture in six communities can shape implementation of a complex intervention: a comparative case study. BMC Health Serv Res. 2022 Feb 17;22(1):221. doi: 10.1186/s12913-022-07615-0.
- Derived from this study: PubMed 32795381Mangin D, Lamarche L, Oliver D, Bomze S, Borhan S, Browne T, Carr T, Datta J, Dolovich L, Howard M, Marentette-Brown S, Risdon C, Talat S, Tarride JE, Thabane L, Valaitis R, Price D. Health TAPESTRY Ontario: protocol for a randomized controlled trial to test reproducibility and implementation. Trials. 2020 Aug 14;21(1):714. doi: 10.1186/s13063-020-04600-y.
- Health TAPESTRY websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Aging
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Not yet recruitingObservational study
Clinical Evaluation of Dual-Plane Technique PN-Based Treatment for Horizontal Neck Lines Using DNA Fragment Opmizing Technology Polynucleotide (DOT PN)
Skin Aging, Horizontal Neck Lines
Not yet recruitingObservational study
Clinical Research on Deep-Plane Rejuran S Injection for Improvement in the Apperance of Periorbital Hollowing Using a Cannula Technique
Periorbital Hollowing, Skin Aging
Recruiting
Aquatic Power Training Dosing Strategies and Creatine Supplementation in Older Adults
Aging, Supplementation
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
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.
Dee Mangin, MBChB,DPH,FR principal investigator
McMaster 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 Health TAPESTRY Intervention in people with Aging, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Jun 2021. 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 Canada. 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?
Change in Hospitalizations (time frame: Change of number of hospitalizations from baseline to 6 months). The study lists 2 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 NCT03397836, which also lists 4 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 10 Jun 2021.