Activities of Daily LivingBingocizeNCT03629912

Bingocize: A Novel Mobile Application for Older Adult Health

A study testing Socially-Based Exercise Intervention for Older Adults in people with Activities of Daily Living and Accidental Fall, run by Western Kentucky University at 4 sites 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

This study tests the effectiveness of using a new mobile application (Bingocize®) to improve older adults' (a) adherence to an engaging exercise program, and (b) aspects of functional performance, health knowledge, dietary habits, and cognition. Read more about this study

Who is it for?: Ages 60 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Activities of Daily Living, Accidental Fall, Sarcopenia
What is being tested?: Socially-Based Exercise Intervention for Older Adults
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 241 participants
Where: 4 sitesUnited States
Study dates: 13 Aug 2018to 13 May 2022
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 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Normal or corrected normal vision
Mobility (i.e., not wheelchair bound)
English is native language
Minimum physical standards (e.g., ability to walk at least 10 meters)
No structured physical activity programs >150 minutes/week in last 6 months

Who cannot join

Severe neurological impairments (e.g., Parkinson's)
Colorblindness
Dementia

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Webster County Senior Center
Dixon, Kentucky, 42409
Chester County Senior Center
Henderson, Tennessee, 38340
Johnson County Senior Center
Johnson City, Tennessee, 37601
Scotts Hill Senior Center
Scotts Hill, Tennessee, 38374

Other trials in United States

About this study

Official title: Bingocize: A Novel Mobile Application to Help Maintain or Improve Older Adults' Health, Function, and Cognition

Read the detailed description

Health-promoting interventions designed to improve physical and mental fitness can help reduce health care costs; they can also help maintain, or even improve, older adults' quality of life. However, getting older adults to adhere to health-promoting exercise interventions remains difficult because such programs are often perceived as being time-consuming, painful, or unenjoyable. The present study's objective is to investigate the effectiveness of a novel technological exercise intervention program for older adults (Bingocize); in doing so, the program has the potential to improve older adults' independence and quality of life. Older adults will participate in a pre/post-intervention design with random assignment to either the experimental or one of three comparison/control groups; each group will play Bingocize in a social setting with other older adults. Participants in the experimental group will use the app to engage in twice-weekly Bingocize sessions for twelve weeks (i.e., Bingo+Exercise+Health Education); control groups will also use the app for twelve weeks but for either health education-only, exercise-only, or bingo-only.

Conditions: Activities of Daily Living, Accidental Fall, Sarcopenia, Arteriosclerosis, Diabetes Mellitus, Type 2, Hypertension
Being tested: Socially-Based Exercise Intervention for Older Adults
Medical subject headings: Sarcopenia, Arteriosclerosis, Diabetes Mellitus, Type 2, Hypertension, Cognitive Dysfunction

What participants receive

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

Socially-Based Exercise Intervention for Older AdultsBehavioural
Also called Bingocize
A socially-based app that incorporates exercise and/or health education into a format familiar and engaging to older adults, designed to improve adherence to health-promoting behaviors

Study groups in NCT03629912
Study group	Role	What they receive
Exercise + Health Education + Bingo	Experimental	Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating exercises AND health information on fall risks + diet/nutrition. Receives: Behavioral: Socially-Based Exercise Intervention for Older Adults
Exercise + Bingo	Active comparator	Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating exercises ONLY. Receives: Behavioral: Socially-Based Exercise Intervention for Older Adults
Health Education + Bingo	Active comparator	Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating health information on fall risks + diet/nutrition ONLY. Receives: Behavioral: Socially-Based Exercise Intervention for Older Adults
Bingo Only	No intervention	Participants use the Bingocize app to play bingo only.

What is being measured

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

Executive Function Inhibition Measure 1: Flanker Task
Flanker Task designed to measure inhibition, part of the EXAMINER Battery (for scoring method, see References section). EXAMINER generates a score that combines reaction time and accuracy data from the incongruent trials. This scoring method generates accuracy and reaction time sub-scales that range in value between 0 and 5, and the ultimate composite score ranges in value between 0 and 10.
Minimum=0, Maximum=10, higher = better.
Measured: Baseline and 12 Weeks
Executive Function Measure: Updating Verbal Working Memory
Dot Counting Task designed to measure verbal working memory, part of the EXAMINER Battery (for scoring method, see References). EXAMINER generates a score is the total number of items correctly recalled across all six trials.
Minimum=0, Maximum=27, higher = better.
Measured: Baseline and 12 Weeks
Executive Function Measure: Set Shifting Task
Set Shifting Task designed to measure attention during task switching, part of the EXAMINER Battery (for scoring method, see References). EXAMINER generates a score that combines reaction time and accuracy data from the incongruent trials. This scoring method generates accuracy and reaction time sub-scales that range in value between 0 and 5, and the ultimate composite score ranges in value between 0 and 10.
Minimum=0, Maximum=10, higher = better.
Measured: Baseline and 12 Weeks
Executive Function Measure: Verbal Fluency
Verbal Fluency Task designed to measure fluency, part of the EXAMINER Battery (for scoring method, see References). EXAMINER generates a score that represents the total number of words correctly recalled in two tasks: phonemic (letter) and semantic (category).
Minimum=0, Maximum=unlimited, higher = better.
Measured: Baseline and 12 Weeks
Chair Stands: Change in Lower-body Muscular Strength
number of completed chair stands in 30 seconds, minimum=0, higher = better
Measured: Baseline and 12 Weeks
Change in Dynamic Balance: 360 Degree Turns
360 degree turns: time to complete. No minimum or maximum value set. Lower = better.
Measured: Baseline and 12 Weeks
Executive Function Measure of Inhibition: Continuous Performance Test
Continuance Performance Task is classic response inhibition task, part of the EXAMINER Battery (for scoring method, see References). The score here represents the number of trials out of 100 that the participant responded correctly (i.e., either successfully responded or successfully inhibited a response).
Minimum=0 Maximum=100, higher = better.
Measured: Baseline and 12 Weeks
Timed Up and Go (TUG) Test: Change in Dynamic Balance
Timed Up and Go (TUG) Test used to assess mobility and risk for falling. Number of seconds needed to stand up from a chair, walk 10 feet, turn around, walk back 10 feet, and sit back down in chair. No minimum or maximum value is set. Lower = better.
Measured: Baseline and 12 Weeks

Secondary outcomes (8)

Crystallized Knowledge of Fall Risks and Proper Diet/Nutrition
Multiple-choice questions constructed by project investigators that cover: recognition of health terms, weight management, proper diet, bone health, environmental fall risks, careful movement. Unit of measure = number correct. Minimum = 0, Maximum = 30. Higher = better.
Measured: Baseline and 12 Weeks
Grip Strength: Changes in Upper Body Muscular Strength
Grip strength tests using a hand-held dynamometer. No minimum or maximum set. Higher = better.
Measured: Baseline and 12 Weeks
Fall Efficacy Scale
Self-reported scale assessing confidence in doing activities that may be perceived as having risk for falling (see References).
Minimum = 10, Maximum = 100. Lower = better.
Measured: Baseline and 12 Weeks
Changes in Dietary Habits: Total Added Sugar Intake
Dietary Screener Questionnaire (DSQ) assessing total added sugar intake over past 30 days
Measured: Baseline and 12 Weeks
Changes in Quality of Life
CDC Health related quality of life measure item 1 (general health). 1 = Excellent, 5 = Poor. Lower = Better.
Measured: Baseline and 12 Weeks
Changes in Weight
Weight calculated by scale measurement
Measured: Baseline and 12 Weeks
Systolic Blood Pressure
Systolic Blood pressure calculated by sphygmomanometer.
Measured: Baseline and 12 Weeks
Diastolic Blood Pressure
Diastolic Blood pressure calculated by sphygmomanometer
Measured: Baseline and 12 Weeks

Timeline

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

13 Aug 201813 May 2022

First posted14 Aug 2018
Study start13 Aug 2018
Primary completion13 May 2022
Study completion13 May 2022

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 (2)Papers the sponsor has linked to this study.
Other trials for Activities of Daily LivingStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: In each wave of the study (14 weeks per wave), participant groups are randomly assigned to one of four conditions (A,B,C,D). Condition A receives exercise + health education. Condition B receives exercise only. Condition C receives health education only. Condition D receives nothing.
Masking: None (open label)
Enrolment: 241 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03629912
Sponsor's protocol ID: IRB 18-048
Other IDs: R15AG055906
Acronym: Bingocize
Status last verified: Feb 2024
First submitted: 6 Aug 2018
Last updated: 12 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.

Publications

Kramer JH, Mungas D, Possin KL, Rankin KP, Boxer AL, Rosen HJ, Bostrom A, Sinha L, Berhel A, Widmeyer M. NIH EXAMINER: conceptualization and development of an executive function battery. J Int Neuropsychol Soc. 2014 Jan;20(1):11-9. doi: 10.1017/S1355617713001094. Epub 2013 Oct 8.
PubMed 24103232
Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239.
PubMed 2229948

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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bingocize: A Novel Mobile Application to Help Maintain or Improve Older Adults' Health, Function, and Cognition
ClinicalTrials.gov ID: NCT03629912
Acronym / sponsor ID: Bingocize / IRB 18-048
Conditions: Activities of Daily Living, Accidental Fall, Sarcopenia, Arteriosclerosis, Diabetes Mellitus, Type 2, Hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 241 participants (actual)
Lead sponsor: Western Kentucky UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 13 Aug 2018 (actual)
Primary completion: 13 May 2022 (actual)
Study completion: 13 May 2022 (actual)
First posted: 14 Aug 2018 (actual)
Results: Posted 12 Mar 2024

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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: In each wave of the study (14 weeks per wave), participant groups are randomly assigned to one of four conditions (A,B,C,D). Condition A receives exercise + health education. Condition B receives exercise only. Condition C receives health education only. Condition D receives nothing.

Arm	Type	Receives
Exercise + Health Education + Bingo	Experimental	Behavioral: Socially-Based Exercise Intervention for Older AdultsSocially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating exercises AND health information on fall risks + diet/nutrition.
Exercise + Bingo	Active comparator	Behavioral: Socially-Based Exercise Intervention for Older AdultsSocially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating exercises ONLY.
Health Education + Bingo	Active comparator	Behavioral: Socially-Based Exercise Intervention for Older AdultsSocially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating health information on fall risks + diet/nutrition ONLY.
Bingo Only	No intervention	–Participants use the Bingocize app to play bingo only.

Who may qualify

Ages: 60 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Normal or corrected normal vision
Mobility (i.e., not wheelchair bound)
English is native language
Minimum physical standards (e.g., ability to walk at least 10 meters)
No structured physical activity programs >150 minutes/week in last 6 months

Key exclusion criteria (3 listed)

Severe neurological impairments (e.g., Parkinson's)
Colorblindness
Dementia

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
Socially-Based Exercise Intervention for Older AdultsAlso: BingocizeA socially-based app that incorporates exercise and/or health education into a format familiar and engaging to older adults, designed to improve adherence to health-promoting behaviors	Behavioural	Exercise + Bingo, Exercise + Health Education + Bingo, Health Education + Bingo

Primary outcome

Executive Function Inhibition Measure 1: Flanker Task
Time frame: Baseline and 12 Weeks
Flanker Task designed to measure inhibition, part of the EXAMINER Battery (for scoring method, see References section). EXAMINER generates a score that combines reaction time and accuracy data from the incongruent trials. This scoring method generates accuracy and reaction time sub-scales that range in value between 0 and 5, and the ultimate composite score ranges in value between 0 and 10. Minimum=0, Maximum=10, higher = better.
Executive Function Measure: Updating Verbal Working Memory
Time frame: Baseline and 12 Weeks
Dot Counting Task designed to measure verbal working memory, part of the EXAMINER Battery (for scoring method, see References). EXAMINER generates a score is the total number of items correctly recalled across all six trials. Minimum=0, Maximum=27, higher = better.
Executive Function Measure: Set Shifting Task
Time frame: Baseline and 12 Weeks
Set Shifting Task designed to measure attention during task switching, part of the EXAMINER Battery (for scoring method, see References). EXAMINER generates a score that combines reaction time and accuracy data from the incongruent trials. This scoring method generates accuracy and reaction time sub-scales that range in value between 0 and 5, and the ultimate composite score ranges in value between 0 and 10. Minimum=0, Maximum=10, higher = better.
Executive Function Measure: Verbal Fluency
Time frame: Baseline and 12 Weeks
Verbal Fluency Task designed to measure fluency, part of the EXAMINER Battery (for scoring method, see References). EXAMINER generates a score that represents the total number of words correctly recalled in two tasks: phonemic (letter) and semantic (category). Minimum=0, Maximum=unlimited, higher = better.
Chair Stands: Change in Lower-body Muscular Strength
Time frame: Baseline and 12 Weeks
number of completed chair stands in 30 seconds, minimum=0, higher = better
Change in Dynamic Balance: 360 Degree Turns
Time frame: Baseline and 12 Weeks
360 degree turns: time to complete. No minimum or maximum value set. Lower = better.
Executive Function Measure of Inhibition: Continuous Performance Test
Time frame: Baseline and 12 Weeks
Continuance Performance Task is classic response inhibition task, part of the EXAMINER Battery (for scoring method, see References). The score here represents the number of trials out of 100 that the participant responded correctly (i.e., either successfully responded or successfully inhibited a response). Minimum=0 Maximum=100, higher = better.
Timed Up and Go (TUG) Test: Change in Dynamic Balance
Time frame: Baseline and 12 Weeks
Timed Up and Go (TUG) Test used to assess mobility and risk for falling. Number of seconds needed to stand up from a chair, walk 10 feet, turn around, walk back 10 feet, and sit back down in chair. No minimum or maximum value is set. Lower = better.

8 secondary outcomes

Crystallized Knowledge of Fall Risks and Proper Diet/Nutrition
Time frame: Baseline and 12 Weeks
Grip Strength: Changes in Upper Body Muscular Strength
Time frame: Baseline and 12 Weeks
Fall Efficacy Scale
Time frame: Baseline and 12 Weeks
Changes in Dietary Habits: Total Added Sugar Intake
Time frame: Baseline and 12 Weeks
Changes in Quality of Life
Time frame: Baseline and 12 Weeks
Changes in Weight
Time frame: Baseline and 12 Weeks
Systolic Blood Pressure
Time frame: Baseline and 12 Weeks
Diastolic Blood Pressure
Time frame: Baseline and 12 Weeks

Results and safety

Results posted to the registry on 12 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exercise + Health Education + Bingo	73	44
Exercise + Bingo	53	40
Health Education + Bingo	50	41
Bingo Only	43	39

Primary outcome: Executive Function Inhibition Measure 1: Flanker Task

Time frame: Baseline and 12 Weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Exercise + Health Education + Bingo n = 44	Exercise + Bingo n = 40	Health Education + Bingo n = 41	Bingo Only n = 39
Baseline	7.30 (1.41)	7.39 (0.95)	7.38 (1.18)	7.51 (1.21)
Post-Intervention	7.66 (.80)	7.54 (.78)	7.63 (.79)	7.86 (.62)

Primary outcome: Executive Function Measure: Updating Verbal Working Memory

Time frame: Baseline and 12 Weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Exercise + Health Education + Bingo n = 43	Exercise + Bingo n = 40	Health Education + Bingo n = 40	Bingo Only n = 39
Baseline	21.60 (2.83)	22.42 (2.43)	22.50 (2.00)	21.69 (2.36)
Post Intervention	22.56 (2.28)	22.87 (2.13)	22.15 (3.10)	22.12 (2.44)

Primary outcome: Executive Function Measure: Set Shifting Task

Time frame: Baseline and 12 Weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Exercise + Health Education + Bingo n = 40	Exercise + Bingo n = 38	Health Education + Bingo n = 41	Bingo Only n = 37
Baseline	6.70 (.93)	6.51 (1.03)	6.67 (.94)	7.05 (.94)
Post-Intervention	6.86 (1.07)	6.82 (.94)	7.04 (.98)	7.08 (1.09)

Primary outcome: Executive Function Measure: Verbal Fluency

Time frame: Baseline and 12 Weeks. Mean (Standard Deviation). Unit: number correct

Measure	Exercise + Health Education + Bingo n = 44	Exercise + Bingo n = 40	Health Education + Bingo n = 41	Bingo Only n = 39
Baseline Phonemic Fluency	9.5 (4.18)	10.9 (4.39)	9.04 (3.86)	10.51 (4.10)
Post Intervention Phonemic Fluency	10.34 (5.02)	9.97 (3.66)	9.04 (3.91)	9.25 (3.71)
Baseline Category Fluency	10.97 (4.03)	11.32 (3.35)	10.73 (3.02)	11.28 (2.88)
Post Intervention Category Fluency	11.06 (3.70)	11.62 (3.74)	9.90 (3.24)	10.97 (2.85)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Twice weekly during 1 hour program sessions, for a duration of 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exercise + Health Education + Bingo	3 of 73 (4.1%)	0 of 73 (0%)	1 of 73
Exercise + Bingo	6 of 53 (11.3%)	0 of 53 (0%)	0 of 53
Health Education + Bingo	3 of 50 (6%)	0 of 50 (0%)	0 of 50
Bingo Only	1 of 43 (2.3%)	0 of 43 (0%)	0 of 43

Limitations and caveats (from the sponsor): COVID-19 Pandemic began in the Middle of this Intervention, resulting in the loss of approximately 35-40% of the overall participant sample who were in the middle of the clinical trial intervention and had to withdraw from the study. Other data collection waves were started and completed before the pandemic, or started and completed after the pandemic, which introduces the possibility of history effects impacting interpretations of the data from participants who did complete the trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24103232Kramer JH, Mungas D, Possin KL, Rankin KP, Boxer AL, Rosen HJ, Bostrom A, Sinha L, Berhel A, Widmeyer M. NIH EXAMINER: conceptualization and development of an executive function battery. J Int Neuropsychol Soc. 2014 Jan;20(1):11-9. doi: 10.1017/S1355617713001094. Epub 2013 Oct 8.
Results publication: PubMed 2229948Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239.
Link to Center for Applied Science in Health \& AgingLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.

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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.

Matthew C Shake, PhD principal investigator

Western Kentucky University and Center for Applied Science in Health and Aging

Jason Crandall, PhD principal investigator

Western Kentucky University and Center for Applied Science in Health and Aging

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

Questions about this trial

What is this clinical trial studying?

A study testing Socially-Based Exercise Intervention for Older Adults in people with Activities of Daily Living and Accidental Fall, run by Western Kentucky University at 4 sites 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 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2024). 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?

Executive Function Inhibition Measure 1: Flanker Task (time frame: Baseline and 12 Weeks). 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 NCT03629912, 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 12 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.