Chronic Conditions, MultipleNCT05240534

ElderTree Via a Voice Activated Device for Managing Chronic Health Conditions (NHLBI)

A study testing ET-Text (Laptop) and ET-Voice (Smart System) in people with Chronic Conditions, Multiple, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: Chronic Conditions, Multiple
What is being tested?: ET-Text (Laptop) and ET-Voice (Smart System)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 502 participants
Where: 1 siteUnited States
Study dates: 29 Apr 2022to 3 Dec 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be ≥60 years old;
Have medical record diagnoses of at least 5 chronic conditions of which at least 3 must come from the following: hypertension, hyperlipidemia, obesity, prediabetes or diabetes, or depression;
Be willing to share medical record data about healthcare use (30-day hospital readmissions and ER, urgent care, primary care, and specialty care visits);
Allow researchers to share information with the patient's primary care provider

Who cannot join

Require an interpreter
Report no current psychotic disorder that would prevent participation
Have no acute medical problem requiring immediate hospitalization
Not report impairments preventing use of a computer or tablet (e.g. blind, deaf)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin
Madison, Wisconsin, 53705

Other trials in United States

About this study

Official title: Using Smart Displays to Implement Evidence-Based eHealth System for Older Adults With Multiple Chronic Conditions (NHLBI)

Multiple chronic conditions (MCCs) are costly and pervasive among older adults. MCCs account for 90% of Medicare spending, and 65% of Medicare beneficiaries have 3 or more chronic conditions; 23% have 5 or more. MCCs are often addressed in primary care, where time pressures force a focus on medication and lab results rather than self-management skills. Patients often struggle with treatment adherence and the emotional and physical burdens of self-management and health tracking. Chronic conditions reduce quality of life (QOL) and increase loneliness, which exacerbate those conditions.

The primary purpose of this study is to investigate whether a voice-based platform is better for delivering an electronic health intervention to older adults than a text/typing-based platform. Elder Tree (ET) is an evidence-based electronic health intervention that has been shown to improve quality of life, physical and socio-emotional health outcomes for older adults with multiple chronic conditions when delivered via a text/typing-based system. The current project would test whether such patients would benefit even more if ET were delivered via a voice-based system (vs. the text-based system) because they would use it more consistently. ET is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health.

Conditions: Chronic Conditions, Multiple
Being tested: ET-Text (Laptop), ET-Voice (Smart System)
Keywords: Voice-activated "smart" technology, Older adults
Medical subject headings: Multiple Chronic Conditions

What participants receive

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

ET-Text (Laptop)Behavioural
Also called ET-LT
ElderTree (ET) is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. Like all CHESS systems, ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ET-Text arm will access ET on Laptop.
ET-Voice (Smart System)Behavioural
Also called ET-SS
ElderTree (ET) is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. Like all CHESS systems, ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ET-Voice arm will access ET on a smart speaker. Voice-activated devices can potentially be easy to use, even by those with limited dexterity or computer experience.

Study groups in NCT05240534
Study group	Role	What they receive
Control group (ET-Text)	Placebo comparator	Participants will receive ElderTree on a laptop. Receives: Behavioral: ET-Text (Laptop)
Experimental group (ET-Voice)	Experimental	Participants will receive ElderTree on a smart system. Receives: Behavioral: ET-Voice (Smart System)

What is being measured

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

Physical Function as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1
Participant reported measure of overall health and level of physical disability. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Lower scores indicate worse outcomes.
Measured: Baseline, 6, 12, 18 months
Pain Interference as Assessed by the PROMIS-29 v2.1
Participant reported measure of pain interference. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.
Measured: Baseline, 6, 12, 18 months
Pain Intensity as Assessed by the PROMIS-29 v2.1
Participant reported measure of pain intensity, this is a single question, with a possible score of 0 to 10. Higher scores indicate worse outcomes.
Measured: Baseline, 6, 12, 18 months
Fatigue as Assessed by the PROMIS-29 v2.1
Participant reported measure of fatigue. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.
Measured: Baseline, 6, 12, 18 months
Sleep as Assessed by the PROMIS-29 v2.1
Participant reported measure of sleep disturbance. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.
Measured: Baseline, 6, 12, 18 months
Anxiety as Assessed by the PROMIS-29 v2.1
Participant reported measure of anxiety. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.
Measured: Baseline, 6, 12, 18 months
Depression as Assessed by the PROMIS-29 v2.1
Participant reported measure of depression. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.
Measured: Baseline, 6, 12, 18 months
Social Roles as Assessed by the PROMIS-29 v2.1
Participant reported measure of satisfaction with participation in social roles. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Lower scores indicate worse outcomes.
Measured: Baseline, 6, 12, 18 months

Secondary outcomes (12)

ElderTree Days of Use
Amount of ElderTree (ET) use will be calculated by the number of days.
Measured: up to 12 months
Physical Function as Assessed by PROMIS-43
Participant reported measure of overall health and level of physical disability. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Lower scores indicate worse outcomes.
Measured: Baseline, 6, 12, 18 months
Pain Interference as Assessed by PROMIS-43
Participant reported measure of pain interference. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.
Measured: Baseline, 6, 12, 18 months
Fatigue as Assessed by PROMIS-43
Participant reported measure of fatigue. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.
Measured: Baseline, 6, 12, 18 months
Sleep Disturbance as Assessed by PROMIS-43
Participant reported measure of sleep disturbance. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.
Measured: Baseline, 6, 12, 18 months
Anxiety as Assessed by PROMIS-43
Participant reported measure of anxiety. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.
Measured: Baseline, 6, 12, 18 months
Depression as Assessed by PROMIS-43
Participant reported measure of depression. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.
Measured: Baseline, 6, 12, 18 months
Social Roles as Assessed by PROMIS-43
Participant reported measure of satisfaction with participation in social roles. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Lower scores indicate worse outcomes.
Measured: Baseline, 6, 12, 18 months
Lorig Health Distress Scale Score
Health distress was measured using the 4-item Lorig Health Distress Scale. The items asked participants to answer regarding the past month. The measure was scored by averaging the items; with higher values indicating more health distress. Possible range is 0 to 5.
Measured: Baseline, 6, 12, 18 months
NIH Toolbox Loneliness Survey Scores
NIH Toolbox Loneliness Survey is a self-report measure that assesses perceptions of loneliness. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate greater perceived loneliness.
Measured: Baseline, 6, 12, 18 months
Number of Unscheduled Healthcare Visits
Participants report at each survey time point the number of urgent care clinic visits, emergency room visits, and overnight hospital stays in the past month.
Measured: Baseline, 6, 12, 18 months
Number of Falls in the Previous 6 Months
The number of falls in the last 6 months
Measured: Baseline, 6, 12, 18 months

Timeline

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

29 Apr 20223 Dec 2025

First posted15 Feb 2022
Study start29 Apr 2022
Primary completion3 Dec 2025
Study completion3 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Conditions, MultipleStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 502 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05240534
Sponsor's protocol ID: 2020-0984
Other IDs: A195000, Protocol Version 11/4/2024, 1R61HL151870-01A1, 5R33HL151870
Status last verified: Sep 2026
First submitted: 4 Feb 2022
Last updated: 20 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gustafson DH Sr, Mares ML, Johnston DC, Curtin JJ, Pe-Romashko K, Landucci G. Comparison of Smart Display Versus Laptop Platforms for an eHealth Intervention to Improve Functional Health for Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2025 Apr 3;14:e64449. doi: 10.2196/64449.
PubMed 40080672

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using Smart Displays to Implement Evidence-Based eHealth System for Older Adults With Multiple Chronic Conditions (NHLBI)
ClinicalTrials.gov ID: NCT05240534
Acronym / sponsor ID: 2020-0984
Conditions: Chronic Conditions, Multiple
Keywords: Voice-activated "smart" technology, Older adults
Study type: Interventional
Recruitment status: Completed
Enrolment: 502 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 29 Apr 2022 (actual)
Primary completion: 3 Dec 2025 (actual)
Study completion: 3 Dec 2025 (actual)
First posted: 15 Feb 2022 (actual)
Results: Posted 20 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Control group (ET-Text)	Placebo comparator	Behavioral: ET-Text (Laptop)Participants will receive ElderTree on a laptop.
Experimental group (ET-Voice)	Experimental	Behavioral: ET-Voice (Smart System)Participants will receive ElderTree on a smart system.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Be ≥60 years old;
Have medical record diagnoses of at least 5 chronic conditions of which at least 3 must come from the following: hypertension, hyperlipidemia, obesity, prediabetes or diabetes, or depression;
Be willing to share medical record data about healthcare use (30-day hospital readmissions and ER, urgent care, primary care, and specialty care visits);
Allow researchers to share information with the patient's primary care provider

Key exclusion criteria (4 listed)

Require an interpreter
Report no current psychotic disorder that would prevent participation
Have no acute medical problem requiring immediate hospitalization
Not report impairments preventing use of a computer or tablet (e.g. blind, deaf)

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
ET-Text (Laptop)Also: ET-LTElderTree (ET) is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. Like all CHESS systems, ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ET-Text arm will access ET on Laptop.	Behavioural	Control group (ET-Text)
ET-Voice (Smart System)Also: ET-SSElderTree (ET) is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. Like all CHESS systems, ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ET-Voice arm will access ET on a smart speaker. Voice-activated devices can potentially be easy to use, even by those with limited dexterity or computer experience.	Behavioural	Experimental group (ET-Voice)

Primary outcome

Physical Function as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1
Time frame: Baseline, 6, 12, 18 months
Participant reported measure of overall health and level of physical disability. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Lower scores indicate worse outcomes.
Pain Interference as Assessed by the PROMIS-29 v2.1
Time frame: Baseline, 6, 12, 18 months
Participant reported measure of pain interference. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.
Pain Intensity as Assessed by the PROMIS-29 v2.1
Time frame: Baseline, 6, 12, 18 months
Participant reported measure of pain intensity, this is a single question, with a possible score of 0 to 10. Higher scores indicate worse outcomes.
Fatigue as Assessed by the PROMIS-29 v2.1
Time frame: Baseline, 6, 12, 18 months
Participant reported measure of fatigue. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.
Sleep as Assessed by the PROMIS-29 v2.1
Time frame: Baseline, 6, 12, 18 months
Participant reported measure of sleep disturbance. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.
Anxiety as Assessed by the PROMIS-29 v2.1
Time frame: Baseline, 6, 12, 18 months
Participant reported measure of anxiety. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.
Depression as Assessed by the PROMIS-29 v2.1
Time frame: Baseline, 6, 12, 18 months
Participant reported measure of depression. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Higher scores indicate worse outcomes.
Social Roles as Assessed by the PROMIS-29 v2.1
Time frame: Baseline, 6, 12, 18 months
Participant reported measure of satisfaction with participation in social roles. This is scored using the standardized T-scores with a general US population mean of 50 and a standard deviation of 10. Lower scores indicate worse outcomes.

12 secondary outcomes

ElderTree Days of Use
Time frame: up to 12 months
Physical Function as Assessed by PROMIS-43
Time frame: Baseline, 6, 12, 18 months
Pain Interference as Assessed by PROMIS-43
Time frame: Baseline, 6, 12, 18 months
Fatigue as Assessed by PROMIS-43
Time frame: Baseline, 6, 12, 18 months
Sleep Disturbance as Assessed by PROMIS-43
Time frame: Baseline, 6, 12, 18 months
Anxiety as Assessed by PROMIS-43
Time frame: Baseline, 6, 12, 18 months
Depression as Assessed by PROMIS-43
Time frame: Baseline, 6, 12, 18 months
Social Roles as Assessed by PROMIS-43
Time frame: Baseline, 6, 12, 18 months
Lorig Health Distress Scale Score
Time frame: Baseline, 6, 12, 18 months
NIH Toolbox Loneliness Survey Scores
Time frame: Baseline, 6, 12, 18 months
Number of Unscheduled Healthcare Visits
Time frame: Baseline, 6, 12, 18 months
Number of Falls in the Previous 6 Months
Time frame: Baseline, 6, 12, 18 months

Results and safety

Results posted to the registry on 20 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ElderTree on Laptop (ET-LT)	251	159
ElderTree on Smart System (ET-SS)	251	170

Primary outcome: Physical Function as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1

Time frame: Baseline, 6, 12, 18 months. Mean (Standard Error). Unit: T-score

Measure	ElderTree on Laptop (ET-LT) n = 188	ElderTree on Smart System (ET-SS) n = 199
Baseline	41.95 (3.15)	42.54 (3.15)
6 months	42.47 (3.19)	42.33 (3.14)
12 months	42.59 (3.22)	41.78 (3.16)
18 months	42.46 (3.22)	42.60 (3.28)

Population analysed: All participants did not return surveys at 6, 12 and 18 month time points.

Primary outcome: Pain Interference as Assessed by the PROMIS-29 v2.1

Time frame: Baseline, 6, 12, 18 months. Mean (Standard Error). Unit: T-score

Measure	ElderTree on Laptop (ET-LT) n = 188	ElderTree on Smart System (ET-SS) n = 199
Baseline	57.82 (2.58)	57.65 (2.55)
6 months	57.15 (2.62)	56.61 (2.73)
12 months	56.41 (2.83)	56.93 (2.58)
18 months	56.80 (2.83)	57.25 (2.61)

Population analysed: All participants did not return surveys at 6, 12 and 18 month time points.

Primary outcome: Pain Intensity as Assessed by the PROMIS-29 v2.1

Time frame: Baseline, 6, 12, 18 months. Mean (Standard Deviation). Unit: score on a scale

Measure	ElderTree on Laptop (ET-LT) n = 188	ElderTree on Smart System (ET-SS) n = 199
Baseline	4.03 (2.50)	4.17 (2.43)
6 months	3.98 (2.48)	3.93 (2.48)
12 months	3.83 (2.65)	4.16 (2.52)
18 months	4.04 (2.62)	4.07 (2.56)

Population analysed: All participants did not return surveys at 6, 12 and 18 month time points.

Primary outcome: Fatigue as Assessed by the PROMIS-29 v2.1

Time frame: Baseline, 6, 12, 18 months. Mean (Standard Error). Unit: T-score

Measure	ElderTree on Laptop (ET-LT) n = 188	ElderTree on Smart System (ET-SS) n = 199
Baseline	52.92 (2.68)	53.21 (2.69)
6 months	51.04 (2.77)	52.73 (2.72)
12 months	51.44 (2.79)	52.27 (2.77)
18 months	51.64 (2.76)	52.48 (2.80)

Population analysed: All participants did not return surveys at 6, 12 and 18 month time points.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From 6 month until 18 month follow-up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ElderTree on Laptop (ET-LT)	0 of 188 (0%)	0 of 188 (0%)	5 of 188
ElderTree on Smart System (ET-SS)	0 of 199 (0%)	0 of 199 (0%)	2 of 199

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40080672Gustafson DH Sr, Mares ML, Johnston DC, Curtin JJ, Pe-Romashko K, Landucci G. Comparison of Smart Display Versus Laptop Platforms for an eHealth Intervention to Improve Functional Health for Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2025 Apr 3;14:e64449. doi: 10.2196/64449.
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.

David H Gustafson, PhD principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ET-Text (Laptop) and ET-Voice (Smart System) in people with Chronic Conditions, Multiple, run by University of Wisconsin, Madison 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 4 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 20 Oct 2026. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 20 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Physical Function as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1 (time frame: Baseline, 6, 12, 18 months). The study lists 8 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 NCT05240534, which also lists 1 linked publication.

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 20 Oct 2026.