ArthritisSPANCT02223858
Staying Positive With Arthritis Study
A study testing Positive Activities (PA) Program in people with Arthritis, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Arthritis is a painful, disabling condition that disproportionately affects African Americans. Existing arthritis treatments yield only small to moderate improvements in pain and are not effective at reducing racial disparities in arthritis pain. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Arthritis
- What is being tested?
- Positive Activities (PA) Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jul 2015to 9 Nov 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The target population will be African American (AA) and White (WH) Veterans with symptomatic knee arthritis. Specific inclusion criteria include:
- Age 50 years or older
- Receive primary care at a participating study site
- Self-report as non-Hispanic black/AA or non-Hispanic WH
- Frequent, symptomatic knee pain identified using questions from the OA Initiative
- Pain level of 4 or higher on a 0-10 numeric rating scale
- Can speak, read, and write in English
Who cannot join
- Patients will be excluded if they:
- Report serious problems with hearing, eyesight, or memory
- Report having been diagnosed any type of arthritis other than osteoarthritis or degenerative arthritis
- Report that they have been treated for cancer in the last 3 years
- Report having had a steroid injection into one or both knees in the past 3 months
- Report having had a knee replacement into one or both knees in the past 3 months
Show all 10Show fewer
- Report having plans to have a knee replacement in one or both knees in the next 6 months
- Report that there is a reason they cannot complete the study procedures, which include telephone calls and program activities that involve reading and writing
- Do not have a telephone number where they can receive telephone calls from research staff
- Screen positive for cognitive impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
About this study
Official title: Staying Positive: An Intervention to Reduce Osteoarthritis Pain Disparities
Arthritis is a painful, disabling condition that disproportionately affects African Americans. Existing arthritis treatments yield only small to moderate improvements in pain and are not effective at reducing racial disparities in arthritis pain. According to the biopsychosocial model of pain, there is a need for novel interventions that target psychosocial factors associated with arthritis outcomes and disparities in outcomes. Evidence from the field of psychology suggests that an intervention designed to develop a positive mindset has the potential to improve pain and functioning and reduce racial disparities in patients with arthritis. Interventions to foster a positive mindset have been developed for clinical patient populations but have not yet been fully tested in patients with arthritis or in Veterans, nor have their effects on racial differences in clinical outcomes been examined. This study will address these gaps by testing the impact of an evidence-based positive activities intervention on pain and functioning in African American and White Veterans with knee arthritis.
Read the detailed description
Background: Arthritis is a prevalent and disabling source of chronic pain for which African Americans (AAs) bear a disproportionate burden. The purpose of this study is to test a patient-centered, non-invasive intervention to improve pain outcomes and reduce disparities in AA and White Veterans with knee arthritis. The intervention is designed to help Veterans develop a positive mindset, the health benefits of which are well-documented.
Objectives: The primary aim of this study is to evaluate the impact of a positive intervention on pain and physical functioning in AA and White Veterans with knee arthritis through a randomized, controlled, clinical trial. It is hypothesized that patients randomized to a positive activities (PA) intervention will experience improved pain and functioning compared to patients randomized to an attention control (AC) program, and that these improvements will be larger for AA than for WH Veterans. The secondary aim of this study is to identify variables that mediate the effects of the PA intervention on pain and functioning. It is hypothesized that the effects of the PA intervention will be mediated by psychosocial variables known to be associated with arthritis outcomes or racial differences in arthritis outcomes (e.g., depression, self-efficacy, pain coping, perceived discrimination).
Methods: A randomized, controlled, 2-arm design will be used to compare the effects of a 6-week PA intervention with that of an AC program on pain and functioning at 1, 3, and 6-months post-intervention among AA and WH Veterans with knee arthritis. Approximately 180 AA and 180 WH primary care patients with knee pain symptoms consistent with arthritis will be recruited from participating VA medical centers following the original protocol. [Due to accelerated recruitment of the original target sample, up to 240 additional primary care patients with knee pain symptoms consistent with OA will be recruited from participating VA medical centers using inclusion criteria that take into account original ICD-9 codes and their corresponding ICD-10 codes. The additional patients (including some men and some women, as resources allow) will be recruited to increase power to detect sex differences in secondary analyses after the primary aims of the study have been achieved using the original cohort.] Eligible participants will complete an in-person baseline assessment of study outcomes, mediators, and control variables and be randomized to a 6-week PA or AC program. The PA program consists of completing 6 at-home activities (1 per week) that have been shown to increase positivity. The AC program consists of 6 affectively neutral activities. Both groups will receive weekly telephone calls from trained interventionists to clarify instructions for the next week's activity and assess completion of the previous week's activity. Outcomes and proposed mediating variables will be assessed via telephone surveys at 1 month, 3 months, and 6 months post-intervention. Study outcomes include self-reported pain and physical functioning as measured by the Western Ontario MacMaster Index. Hypothesized mediators include depressive symptoms, positive/negative affect, satisfaction with life, arthritis self-efficacy, pain coping, pain catastrophizing, perceived discrimination, global stress, and social support. The intervention impact over time and by race (primary aim) will be tested using linear mixed models that allow repeated measures on the continuous outcomes for each participant and assess change in outcomes over time. A multiple mediator bootstrap approach to assess whether the effect of the intervention is mediated by the hypothesized mediators.
- Conditions
- Arthritis
- Being tested
- Positive Activities (PA) Program, Attention Control (AC) Program
- Keywords
- Health Status Disparities, Arthritis, Psychology, Pain Management, Affect
- Medical subject headings
- Arthritis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Activities (PA) ProgramBehavioural
6-week program of at-home activities (1 per week) that have been shown to increase positivity. Activities were delivered via activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. Interventionist oriented participants to the booklets and reviewed the first activity at the end of an in-person baseline visit. Booklets contained all instructions patients needed to complete the full program. Interventionists also provided support via weekly calls in which they assessed completion of the previous week's activity, reviewed instructions for the next activity, and helped participants trouble-shoot anticipated barriers.
Attention Control (AC) ProgramBehavioural
6-week program of at-home activities (1 per week) based on affectively neutral activities from control conditions in studies of positive activities interventions. Activities were delivered via activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. Interventionist oriented participants to the booklets and reviewed the first activity at the end of an in-person baseline visit. Booklets contained all instructions patients needed to complete the full program. Interventionists also provided support via weekly calls in which they assessed completion of the previous week's activity, reviewed instructions for the next activity, and helped participants trouble-shoot anticipated barriers.
| Study group | Role | What they receive |
|---|---|---|
| Positive Activities (PA) | Experimental | Positive Activities (PA) Program Receives: Behavioral: Positive Activities (PA) Program |
| Attention Control (AC) | Active comparator | Attention Control (AC) Program Receives: Behavioral: Attention Control (AC) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention
Pain subscale of the Western Ontario McMaster (WOMAC) Index. Pain is on a scale of 0-100; higher scores mean worse pain.
Measured: Baseline to 6 months post-intervention
Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention
Difficulty with physical functioning subscale of the Western Ontario McMaster (WOMAC) Index. Physical functioning is on a scale of 0-100; higher scores mean worse physical functioning.
Measured: Baseline to 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study start13 Jul 2015
- Primary completion9 Nov 2017
- Study completion9 Nov 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 (5)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomization will be at the patient level, stratified by study site and patient race, with a 1:1 allocation using random block sizes of 2, 4, 6, or 8.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Leslie RM Hausmann, PhD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223858
- Sponsor's protocol ID
- IIR 13-080
- Acronym
- SPA
- Status last verified
- Mar 2019
- First submitted
- 18 Aug 2014
- Last updated
- 3 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hausmann LRM, Ibrahim SA, Kwoh CK, Youk A, Obrosky DS, Weiner DK, Vina E, Gallagher RM, Mauro GT, Parks A. Rationale and design of the Staying Positive with Arthritis (SPA) Study: A randomized controlled trial testing the impact of a positive psychology intervention on racial disparities in pain. Contemp Clin Trials. 2018 Jan;64:243-253. doi: 10.1016/j.cct.2017.09.001. Epub 2017 Sep 8.
PubMed 28893676Hausmann LRM, Youk A, Kwoh CK, Ibrahim SA, Hannon MJ, Weiner DK, Gallagher RM, Parks A. Testing a Positive Psychological Intervention for Osteoarthritis. Pain Med. 2017 Oct 1;18(10):1908-1920. doi: 10.1093/pm/pnx141.
PubMed 29044408Vina ER, Hausmann LRM, Obrosky DS, Youk A, Ibrahim SA, Weiner DK, Gallagher RM, Kwoh CK. Social & psychological factors associated with oral analgesic use in knee osteoarthritis management. Osteoarthritis Cartilage. 2019 Jul;27(7):1018-1025. doi: 10.1016/j.joca.2019.01.010. Epub 2019 Feb 1.
PubMed 30716537McClendon J, Essien UR, Youk A, Ibrahim SA, Vina E, Kwoh CK, Hausmann LRM. Cumulative Disadvantage and Disparities in Depression and Pain Among Veterans With Osteoarthritis: The Role of Perceived Discrimination. Arthritis Care Res (Hoboken). 2021 Jan;73(1):11-17. doi: 10.1002/acr.24481.
PubMed 33026710Hausmann LRM, Youk A, Kwoh CK, Gallagher RM, Weiner DK, Vina ER, Obrosky DS, Mauro GT, McInnes S, Ibrahim SA. Effect of a Positive Psychological Intervention on Pain and Functional Difficulty Among Adults With Osteoarthritis: A Randomized Clinical Trial. JAMA Netw Open. 2018 Sep 7;1(5):e182533. doi: 10.1001/jamanetworkopen.2018.2533.
PubMed 30646170
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staying Positive: An Intervention to Reduce Osteoarthritis Pain Disparities
- ClinicalTrials.gov ID
- NCT02223858
- Acronym / sponsor ID
- SPA / IIR 13-080
- Conditions
- Arthritis
- Keywords
- Health Status Disparities, Arthritis, Psychology, Pain Management, Affect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 13 Jul 2015 (actual)
- Primary completion
- 9 Nov 2017 (actual)
- Study completion
- 9 Nov 2017 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Posted 11 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Arthritis is a painful, disabling condition that disproportionately affects African Americans. Existing arthritis treatments yield only small to moderate improvements in pain and are not effective at reducing racial disparities in arthritis pain. According to the biopsychosocial model of pain, there is a need for novel interventions that target psychosocial factors associated with arthritis outcomes and disparities in outcomes. Evidence from the field of psychology suggests that an intervention designed to develop a positive mindset has the potential to improve pain and functioning and reduce racial disparities in patients with arthritis. Interventions to foster a positive mindset have been developed for clinical patient populations but have not yet been fully tested in patients with arthritis or in Veterans, nor have their effects on racial differences in clinical outcomes been examined. This study will address these gaps by testing the impact of an evidence-based positive activities intervention on pain and functioning in African American and White Veterans with knee arthritis.
Detailed description
Background: Arthritis is a prevalent and disabling source of chronic pain for which African Americans (AAs) bear a disproportionate burden. The purpose of this study is to test a patient-centered, non-invasive intervention to improve pain outcomes and reduce disparities in AA and White Veterans with knee arthritis. The intervention is designed to help Veterans develop a positive mindset, the health benefits of which are well-documented.
Objectives: The primary aim of this study is to evaluate the impact of a positive intervention on pain and physical functioning in AA and White Veterans with knee arthritis through a randomized, controlled, clinical trial. It is hypothesized that patients randomized to a positive activities (PA) intervention will experience improved pain and functioning compared to patients randomized to an attention control (AC) program, and that these improvements will be larger for AA than for WH Veterans. The secondary aim of this study is to identify variables that mediate the effects of the PA intervention on pain and functioning. It is hypothesized that the effects of the PA intervention will be mediated by psychosocial variables known to be associated with arthritis outcomes or racial differences in arthritis outcomes (e.g., depression, self-efficacy, pain coping, perceived discrimination).
Methods: A randomized, controlled, 2-arm design will be used to compare the effects of a 6-week PA intervention with that of an AC program on pain and functioning at 1, 3, and 6-months post-intervention among AA and WH Veterans with knee arthritis. Approximately 180 AA and 180 WH primary care patients with knee pain symptoms consistent with arthritis will be recruited from participating VA medical centers following the original protocol. [Due to accelerated recruitment of the original target sample, up to 240 additional primary care patients with knee pain symptoms consistent with OA will be recruited from participating VA medical centers using inclusion criteria that take into account original ICD-9 codes and their corresponding ICD-10 codes. The additional patients (including some men and some women, as resources allow) will be recruited to increase power to detect sex differences in secondary analyses after the primary aims of the study have been achieved using the original cohort.] Eligible participants will complete an in-person baseline assessment of study outcomes, mediators, and control variables and be randomized to a 6-week PA or AC program. The PA program consists of completing 6 at-home activities (1 per week) that have been shown to increase positivity. The AC program consists of 6 affectively neutral activities. Both groups will receive weekly telephone calls from trained interventionists to clarify instructions for the next week's activity and assess completion of the previous week's activity. Outcomes and proposed mediating variables will be assessed via telephone surveys at 1 month, 3 months, and 6 months post-intervention. Study outcomes include self-reported pain and physical functioning as measured by the Western Ontario MacMaster Index. Hypothesized mediators include depressive symptoms, positive/negative affect, satisfaction with life, arthritis self-efficacy, pain coping, pain catastrophizing, perceived discrimination, global stress, and social support. The intervention impact over time and by race (primary aim) will be tested using linear mixed models that allow repeated measures on the continuous outcomes for each participant and assess change in outcomes over time. A multiple mediator bootstrap approach to assess whether the effect of the intervention is mediated by the hypothesized mediators.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization will be at the patient level, stratified by study site and patient race, with a 1:1 allocation using random block sizes of 2, 4, 6, or 8.
| Arm | Type | Receives |
|---|---|---|
| Positive Activities (PA) | Experimental | Behavioral: Positive Activities (PA) ProgramPositive Activities (PA) Program |
| Attention Control (AC) | Active comparator | Behavioral: Attention Control (AC) ProgramAttention Control (AC) Program |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The target population will be African American (AA) and White (WH) Veterans with symptomatic knee arthritis. Specific inclusion criteria include:
- Age 50 years or older
- Receive primary care at a participating study site
- Self-report as non-Hispanic black/AA or non-Hispanic WH
- Frequent, symptomatic knee pain identified using questions from the OA Initiative
Key exclusion criteria (10 listed)
- Report serious problems with hearing, eyesight, or memory
- Report having been diagnosed any type of arthritis other than osteoarthritis or degenerative arthritis
- Report that they have been treated for cancer in the last 3 years
- Report having had a steroid injection into one or both knees in the past 3 months
- Report having had a knee replacement into one or both knees in the past 3 months
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 |
|---|---|---|
| Positive Activities (PA) Program6-week program of at-home activities (1 per week) that have been shown to increase positivity. Activities were delivered via activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. Interventionist oriented participants to the booklets and reviewed the first activity at the end of an in-person baseline visit. Booklets contained all instructions patients needed to complete the full program. Interventionists also provided support via weekly calls in which they assessed completion of the previous week's activity, reviewed instructions for the next activity, and helped participants trouble-shoot anticipated barriers. | Behavioural | Positive Activities (PA) |
| Attention Control (AC) Program6-week program of at-home activities (1 per week) based on affectively neutral activities from control conditions in studies of positive activities interventions. Activities were delivered via activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. Interventionist oriented participants to the booklets and reviewed the first activity at the end of an in-person baseline visit. Booklets contained all instructions patients needed to complete the full program. Interventionists also provided support via weekly calls in which they assessed completion of the previous week's activity, reviewed instructions for the next activity, and helped participants trouble-shoot anticipated barriers. | Behavioural | Attention Control (AC) |
Primary outcome
Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention
Time frame: Baseline to 6 months post-intervention
Pain subscale of the Western Ontario McMaster (WOMAC) Index. Pain is on a scale of 0-100; higher scores mean worse pain.
Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention
Time frame: Baseline to 6 months post-intervention
Difficulty with physical functioning subscale of the Western Ontario McMaster (WOMAC) Index. Physical functioning is on a scale of 0-100; higher scores mean worse physical functioning.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28893676Hausmann LRM, Ibrahim SA, Kwoh CK, Youk A, Obrosky DS, Weiner DK, Vina E, Gallagher RM, Mauro GT, Parks A. Rationale and design of the Staying Positive with Arthritis (SPA) Study: A randomized controlled trial testing the impact of a positive psychology intervention on racial disparities in pain. Contemp Clin Trials. 2018 Jan;64:243-253. doi: 10.1016/j.cct.2017.09.001. Epub 2017 Sep 8.
- Background: PubMed 29044408Hausmann LRM, Youk A, Kwoh CK, Ibrahim SA, Hannon MJ, Weiner DK, Gallagher RM, Parks A. Testing a Positive Psychological Intervention for Osteoarthritis. Pain Med. 2017 Oct 1;18(10):1908-1920. doi: 10.1093/pm/pnx141.
- Results publication: PubMed 30716537Vina ER, Hausmann LRM, Obrosky DS, Youk A, Ibrahim SA, Weiner DK, Gallagher RM, Kwoh CK. Social & psychological factors associated with oral analgesic use in knee osteoarthritis management. Osteoarthritis Cartilage. 2019 Jul;27(7):1018-1025. doi: 10.1016/j.joca.2019.01.010. Epub 2019 Feb 1.
- Derived from this study: PubMed 33026710McClendon J, Essien UR, Youk A, Ibrahim SA, Vina E, Kwoh CK, Hausmann LRM. Cumulative Disadvantage and Disparities in Depression and Pain Among Veterans With Osteoarthritis: The Role of Perceived Discrimination. Arthritis Care Res (Hoboken). 2021 Jan;73(1):11-17. doi: 10.1002/acr.24481.
- Derived from this study: PubMed 30646170Hausmann LRM, Youk A, Kwoh CK, Gallagher RM, Weiner DK, Vina ER, Obrosky DS, Mauro GT, McInnes S, Ibrahim SA. Effect of a Positive Psychological Intervention on Pain and Functional Difficulty Among Adults With Osteoarthritis: A Randomized Clinical Trial. JAMA Netw Open. 2018 Sep 7;1(5):e182533. doi: 10.1001/jamanetworkopen.2018.2533.
- 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.
Leslie RM Hausmann, PhD principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Activities (PA) Program in people with Arthritis, run by VA Office of Research and Development at 2 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 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 11 Feb 2019). 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?
Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention (time frame: Baseline to 6 months post-intervention). 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 NCT02223858, which also lists 5 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 3 Apr 2019.