AgingSTEP4LifeNCT03001778
Smart Television and Exercise Promotion for Independent Living Facilities
A study testing Usability Testing in people with Aging and Physical Activity, run by Klein Buendel, Inc. at 1 site in United States.
Trial summary
Physical activity (PA) has physical, emotional, and cognitive benefits for seniors (e.g., increased strength and balance, reduced frailty, fewer falls, improved brain function, lower mortality risk), yet many seniors have limited access to exercise options due to numerous barriers (e.g., transportation concerns… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Physical Activity
- What is being tested?
- Usability Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2014to 30 Jun 2017
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Independent Living Facility (ILF) Resident Inclusion Criteria:
- 55 years of age or older
- live in an ILF
- able tor read and speak English
- able to consent to participate
- exercise 60 min or more a week (self-reported)
ILF Resident Exclusion Criteria:
- under 55 years of age
- not live in an ILF
- unable to read and speak English
- unable to consent to participate
- exercise less than 60 minutes (self-reported)
Non-ILF Resident Inclusion Criteria:
- 55 years of age or older
- not live in an ILF
- able to read and speak English
- able to consent to participate
- exercise 60 min or more a week (self-reported)
Non-ILF Resident Exclusion Criteria:
- under 55 years of age
- live in an ILF
- unable to read and speak English
- unable to consent to participate
- exercise less than 60 minutes (self-reported)
Trial locations and contacts
1 site in 1 country.
About this study
Physical activity (PA) has physical, emotional, and cognitive benefits for seniors (e.g., increased strength and balance, reduced frailty, fewer falls, improved brain function, lower mortality risk), yet many seniors have limited access to exercise options due to numerous barriers (e.g., transportation concerns, financial costs, fear of injury/falling). This project will overcome common exercise barriers by creating an interactive web-enabled TV program (i.e., Smart TV), adapted from research-based PA protocols, to be implemented in an Independent Living Facility (ILF) setting. A web-based prototype will be developed, and ILF residents and administrators will be able to create, use, and evaluate a customizable exercise program tailored to the individual's preferred type of exercise, intensity, and duration.
Read the detailed description
Older Adults (OAs), aged 65 years and older, are the fastest growing segment of the U.S. population. As life expectancy increases, maintaining physical independence has become a public health priority. It is well recognized that regular physical activity (PA) can be done safely by seniors, and has multiple physical, emotional, and cognitive benefits. Yet, they remain the least physically active of any age group. This suggests that the translational reach of efficacious PA protocols to the real-world remains limited, and a need for research which is scalable to the individual in more naturalistic settings exists. An emerging trend for seniors is to choose Independent Living Facilities (ILFs) as their home. ILFs offer a variety of social, cultural, and fitness services. Access to up-to-date technologies (e.g., wireless Internet), web-based education, and wellness programs are a priority for ILF residents, thus opportunities for using technology for health promotion with OAs exists. ILFs provide a unique opportunity for PA promotion, because 1) more seniors are choosing ILFs for aging-in-place, 2) PA is of interest to ILF residents, 3) ILFs should continue to increase their wellness offerings, and 4) ILFs should be interested in incorporating PA programs into wellness offerings. Research is needed to translate efficacious PA protocols for seniors into formats that are scalable to OAs in real-world settings. The goal is to extrapolate knowledge gained from efficacy research to improve the utilization and sustainability of evidence-based methods by producing programs that are agreeable, user-friendly, and optimal at both the individual and organizational level. Smart Television and Exercise Promotion for Independent Living Facilities (STEP for LIFE) will establish the feasibility for translating an evidence-based PA program using an interactive web-enabled, streaming-video technology (i.e., Smart TV) for ILF residents. This program offers 1) an innovative and potentially effective medium to reach seniors, 2) the ability to select and sequence together a session that is personalized to fitness level, type of exercise, and duration, and 3) organizations the ability to provide desired wellness options which meet both resident and organizational needs. The purpose of this study is to provide the initial research for translating efficacious research-based PA protocols for seniors into a scalable format usable in a real-world ILF setting, and to gain knowledge at individual and organizational levels to improve implementation and sustainability of this evidence-based approach. Specific Aims include extensive formative research on the use, interest, and effectiveness of interactive multimedia approaches for promoting PA, and its integration into senior living settings. A working prototype will be developed and tested for usability with ILF residents and administrators, and seniors not residing in ILFs. Outcomes will establish the feasibility of producing and testing STEP for LIFE in a large-scale randomized trial. A larger trial can inform 1) future translation of PA promotion to other OA residential settings (e.g., assisted living, memory care, rural settings), and 2) sustainable implementation strategies for other evidence-based health promotion protocols for seniors.
- Conditions
- Aging, Physical Activity
- Being tested
- Usability Testing
- Keywords
- Physical Activity, Older Adults, Independent Living Facilities, Multimedia technology
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usability TestingOther
Usability testing of "ready made" workouts in a group format.
| Study group | Role | What they receive |
|---|---|---|
| Usability Testing | Experimental | Prototype testing Receives: Other: Usability Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale (SUS)
Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from "Strongly Agree" to "Strongly Disagree". Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged.
Measured: After 1 hour usability session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study start15 Aug 2014
- Primary completion30 Jan 2017
- Study completion30 Jun 2017
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 (26)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Valerie Myers, PhD', Principal investigator, Klein Buendel, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001778
- Sponsor's protocol ID
- R21AG046670
- Other IDs
- 5R21AG046670, 0283
- Acronym
- STEP4Life
- Status last verified
- Aug 2018
- First submitted
- 13 Dec 2016
- Last updated
- 20 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chan DC, Tsou HH, Yang RS, Tsauo JY, Chen CY, Hsiung CA, Kuo KN. A pilot randomized controlled trial to improve geriatric frailty. BMC Geriatr. 2012 Sep 25;12:58. doi: 10.1186/1471-2318-12-58.
PubMed 23009149Xue QL, Bandeen-Roche K, Mielenz TJ, Seplaki CL, Szanton SL, Thorpe RJ, Kalyani RR, Chaves PH, Dam TT, Ornstein K, RoyChoudhury A, Varadhan R, Yao W, Fried LP. Patterns of 12-year change in physical activity levels in community-dwelling older women: can modest levels of physical activity help older women live longer? Am J Epidemiol. 2012 Sep 15;176(6):534-43. doi: 10.1093/aje/kws125. Epub 2012 Aug 30.
PubMed 22935515Langlois F, Vu TT, Chasse K, Dupuis G, Kergoat MJ, Bherer L. Benefits of physical exercise training on cognition and quality of life in frail older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):400-4. doi: 10.1093/geronb/gbs069. Epub 2012 Aug 28.
PubMed 22929394Kamegaya T; Long-Term-Care Prevention Team of Maebashi City; Maki Y, Yamagami T, Yamaguchi T, Murai T, Yamaguchi H. Pleasant physical exercise program for prevention of cognitive decline in community-dwelling elderly with subjective memory complaints. Geriatr Gerontol Int. 2012 Oct;12(4):673-9. doi: 10.1111/j.1447-0594.2012.00840.x. Epub 2012 Apr 2.
PubMed 22469534Uemura K, Doi T, Shimada H, Makizako H, Yoshida D, Tsutsumimoto K, Anan Y, Suzuki T. Effects of exercise intervention on vascular risk factors in older adults with mild cognitive impairment: a randomized controlled trial. Dement Geriatr Cogn Dis Extra. 2012 Jan;2(1):445-55. doi: 10.1159/000343486. Epub 2012 Oct 25.
PubMed 23189083Concannon LG, Grierson MJ, Harrast MA. Exercise in the older adult: from the sedentary elderly to the masters athlete. PM R. 2012 Nov;4(11):833-9. doi: 10.1016/j.pmrj.2012.08.007.
PubMed 23174546Rydwik E, Welmer AK, Kareholt I, Angleman S, Fratiglioni L, Wang HX. Adherence to physical exercise recommendations in people over 65--the SNAC-Kungsholmen study. Eur J Public Health. 2013 Oct;23(5):799-804. doi: 10.1093/eurpub/cks150. Epub 2012 Oct 31.
PubMed 23115329Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91. doi: 10.1001/jama.2009.643.
PubMed 19436015Faber MJ, Bosscher RJ, Chin A Paw MJ, van Wieringen PC. Effects of exercise programs on falls and mobility in frail and pre-frail older adults: A multicenter randomized controlled trial. Arch Phys Med Rehabil. 2006 Jul;87(7):885-96. doi: 10.1016/j.apmr.2006.04.005.
PubMed 16813773Li F, Harmer P, Fisher KJ, McAuley E, Chaumeton N, Eckstrom E, Wilson NL. Tai Chi and fall reductions in older adults: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2005 Feb;60(2):187-94. doi: 10.1093/gerona/60.2.187.
PubMed 15814861Spirduso WW, Cronin DL. Exercise dose-response effects on quality of life and independent living in older adults. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S598-608; discussion S609-10. doi: 10.1097/00005768-200106001-00028.
PubMed 11427784Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430.
PubMed 12661673Mather AS, Rodriguez C, Guthrie MF, McHarg AM, Reid IC, McMurdo ME. Effects of exercise on depressive symptoms in older adults with poorly responsive depressive disorder: randomised controlled trial. Br J Psychiatry. 2002 May;180:411-5. doi: 10.1192/bjp.180.5.411.
PubMed 11983637Sze PC, Cheung WH, Lam PS, Lo HS, Leung KS, Chan T. The efficacy of a multidisciplinary falls prevention clinic with an extended step-down community program. Arch Phys Med Rehabil. 2008 Jul;89(7):1329-34. doi: 10.1016/j.apmr.2007.11.044.
PubMed 18586135Stevens JA, Sogolow ED. Preventing Falls: What Works: A CDC Compendium of Effective Community-Based Interventions From Around the World. National Center for Injury Prevention and Control; 2008.
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Television and Exercise Promotion for Independent Living Facilities
- ClinicalTrials.gov ID
- NCT03001778
- Acronym / sponsor ID
- STEP4Life / R21AG046670
- Conditions
- Aging, Physical Activity
- Keywords
- Physical Activity, Older Adults, Independent Living Facilities, Multimedia technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Aug 2014 (actual)
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Posted 20 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physical activity (PA) has physical, emotional, and cognitive benefits for seniors (e.g., increased strength and balance, reduced frailty, fewer falls, improved brain function, lower mortality risk), yet many seniors have limited access to exercise options due to numerous barriers (e.g., transportation concerns, financial costs, fear of injury/falling). This project will overcome common exercise barriers by creating an interactive web-enabled TV program (i.e., Smart TV), adapted from research-based PA protocols, to be implemented in an Independent Living Facility (ILF) setting. A web-based prototype will be developed, and ILF residents and administrators will be able to create, use, and evaluate a customizable exercise program tailored to the individual's preferred type of exercise, intensity, and duration.
Detailed description
Older Adults (OAs), aged 65 years and older, are the fastest growing segment of the U.S. population. As life expectancy increases, maintaining physical independence has become a public health priority. It is well recognized that regular physical activity (PA) can be done safely by seniors, and has multiple physical, emotional, and cognitive benefits. Yet, they remain the least physically active of any age group. This suggests that the translational reach of efficacious PA protocols to the real-world remains limited, and a need for research which is scalable to the individual in more naturalistic settings exists. An emerging trend for seniors is to choose Independent Living Facilities (ILFs) as their home. ILFs offer a variety of social, cultural, and fitness services. Access to up-to-date technologies (e.g., wireless Internet), web-based education, and wellness programs are a priority for ILF residents, thus opportunities for using technology for health promotion with OAs exists. ILFs provide a unique opportunity for PA promotion, because 1) more seniors are choosing ILFs for aging-in-place, 2) PA is of interest to ILF residents, 3) ILFs should continue to increase their wellness offerings, and 4) ILFs should be interested in incorporating PA programs into wellness offerings. Research is needed to translate efficacious PA protocols for seniors into formats that are scalable to OAs in real-world settings. The goal is to extrapolate knowledge gained from efficacy research to improve the utilization and sustainability of evidence-based methods by producing programs that are agreeable, user-friendly, and optimal at both the individual and organizational level. Smart Television and Exercise Promotion for Independent Living Facilities (STEP for LIFE) will establish the feasibility for translating an evidence-based PA program using an interactive web-enabled, streaming-video technology (i.e., Smart TV) for ILF residents. This program offers 1) an innovative and potentially effective medium to reach seniors, 2) the ability to select and sequence together a session that is personalized to fitness level, type of exercise, and duration, and 3) organizations the ability to provide desired wellness options which meet both resident and organizational needs. The purpose of this study is to provide the initial research for translating efficacious research-based PA protocols for seniors into a scalable format usable in a real-world ILF setting, and to gain knowledge at individual and organizational levels to improve implementation and sustainability of this evidence-based approach. Specific Aims include extensive formative research on the use, interest, and effectiveness of interactive multimedia approaches for promoting PA, and its integration into senior living settings. A working prototype will be developed and tested for usability with ILF residents and administrators, and seniors not residing in ILFs. Outcomes will establish the feasibility of producing and testing STEP for LIFE in a large-scale randomized trial. A larger trial can inform 1) future translation of PA promotion to other OA residential settings (e.g., assisted living, memory care, rural settings), and 2) sustainable implementation strategies for other evidence-based health promotion protocols for seniors.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usability Testing | Experimental | Other: Usability TestingPrototype testing |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, 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 |
|---|---|---|
| Usability TestingUsability testing of "ready made" workouts in a group format. | Other | Usability Testing |
Primary outcome
System Usability Scale (SUS)
Time frame: After 1 hour usability session
Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from "Strongly Agree" to "Strongly Disagree". Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23009149Chan DC, Tsou HH, Yang RS, Tsauo JY, Chen CY, Hsiung CA, Kuo KN. A pilot randomized controlled trial to improve geriatric frailty. BMC Geriatr. 2012 Sep 25;12:58. doi: 10.1186/1471-2318-12-58.
- Background: PubMed 22935515Xue QL, Bandeen-Roche K, Mielenz TJ, Seplaki CL, Szanton SL, Thorpe RJ, Kalyani RR, Chaves PH, Dam TT, Ornstein K, RoyChoudhury A, Varadhan R, Yao W, Fried LP. Patterns of 12-year change in physical activity levels in community-dwelling older women: can modest levels of physical activity help older women live longer? Am J Epidemiol. 2012 Sep 15;176(6):534-43. doi: 10.1093/aje/kws125. Epub 2012 Aug 30.
- Background: PubMed 22929394Langlois F, Vu TT, Chasse K, Dupuis G, Kergoat MJ, Bherer L. Benefits of physical exercise training on cognition and quality of life in frail older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):400-4. doi: 10.1093/geronb/gbs069. Epub 2012 Aug 28.
- Background: PubMed 22469534Kamegaya T; Long-Term-Care Prevention Team of Maebashi City; Maki Y, Yamagami T, Yamaguchi T, Murai T, Yamaguchi H. Pleasant physical exercise program for prevention of cognitive decline in community-dwelling elderly with subjective memory complaints. Geriatr Gerontol Int. 2012 Oct;12(4):673-9. doi: 10.1111/j.1447-0594.2012.00840.x. Epub 2012 Apr 2.
- Background: PubMed 23189083Uemura K, Doi T, Shimada H, Makizako H, Yoshida D, Tsutsumimoto K, Anan Y, Suzuki T. Effects of exercise intervention on vascular risk factors in older adults with mild cognitive impairment: a randomized controlled trial. Dement Geriatr Cogn Dis Extra. 2012 Jan;2(1):445-55. doi: 10.1159/000343486. Epub 2012 Oct 25.
- Background: PubMed 23174546Concannon LG, Grierson MJ, Harrast MA. Exercise in the older adult: from the sedentary elderly to the masters athlete. PM R. 2012 Nov;4(11):833-9. doi: 10.1016/j.pmrj.2012.08.007.
- Background: PubMed 23115329Rydwik E, Welmer AK, Kareholt I, Angleman S, Fratiglioni L, Wang HX. Adherence to physical exercise recommendations in people over 65--the SNAC-Kungsholmen study. Eur J Public Health. 2013 Oct;23(5):799-804. doi: 10.1093/eurpub/cks150. Epub 2012 Oct 31.
- Background: PubMed 19436015Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91. doi: 10.1001/jama.2009.643.
- Background: PubMed 16813773Faber MJ, Bosscher RJ, Chin A Paw MJ, van Wieringen PC. Effects of exercise programs on falls and mobility in frail and pre-frail older adults: A multicenter randomized controlled trial. Arch Phys Med Rehabil. 2006 Jul;87(7):885-96. doi: 10.1016/j.apmr.2006.04.005.
- Background: PubMed 15814861Li F, Harmer P, Fisher KJ, McAuley E, Chaumeton N, Eckstrom E, Wilson NL. Tai Chi and fall reductions in older adults: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2005 Feb;60(2):187-94. doi: 10.1093/gerona/60.2.187.
- Background: PubMed 11427784Spirduso WW, Cronin DL. Exercise dose-response effects on quality of life and independent living in older adults. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S598-608; discussion S609-10. doi: 10.1097/00005768-200106001-00028.
- Background: PubMed 12661673Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430.
- Individual participant dataSharing planned: No
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
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.
Valerie Myers, PhD' principal investigator
Klein Buendel, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usability Testing in people with Aging and Physical Activity, run by Klein Buendel, Inc. 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?
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 Sep 2018. 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. 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 Sep 2018). 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?
System Usability Scale (SUS) (time frame: After 1 hour usability session). 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 NCT03001778, which also lists 26 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 20 Sep 2018.