4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis

Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis

Study Description
Brief Summary:
This study will investigate if mindfulness training via a smartphone mobile app is effective in improving OA-related knee pain.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Pain Device: Intervention -- "Headspace" mindfulness application Device: Control -- "My Water Balance" application Not Applicable

Detailed Description:
The investigator's primary aim in this study is to determine if regular use of a mindfulness application improves pain outcomes in adults with knee osteoarthritis. The investigator's secondary aim is to determine if self-reported Healthcare-Related Quality of Life (HRQoL) scores predict response to mindfulness treatment in OA. The investigators hypothesize that the use of an mHealth intervention for mindfulness training may be an effective adjunct treatment of chronic knee osteoarthritis pain; specifically, that regular use of a mindfulness application will result in a statistically significant reduction in pain outcomes and improvement in physical function as determined by the KOOS scoring system. The investigators also hypothesize that those with lower baseline self-reported HRQoL scores are more likely to see a greater improvement in their pain and function with use of a mindfulness application than those with higher baseline scores.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Intervention with Mindfulness App (Headspace)
Patient education regarding osteoarthritis, its natural history, and common treatments plus the mindfulness (intervention) app.
 Device: Intervention -- "Headspace" mindfulness application
Patients will be provided with a pre-paid 12-week subscription to the mindfulness application, and provided an in-person demonstration on how to use it, and the subscription license code will be recorded for the purposes of tracking use after the conclusion of the study. The intervention group will be asked to use the mindfulness app 10 minutes per day/5 days per week. To standardize Pack usage across all participants, users will be asked to complete the Headspace Essentials", "Pain Management", and "Physical Health" Session Packs.
Active Comparator: Control with Water App (My Water Balance)
Patient education regarding osteoarthritis, its natural history, and common treatments plus the My Water Balance (control) app and provided an in-person demonstration on how to use it.
 Device: Control -- "My Water Balance" application
My Water Balance calculates an individual's recommended daily water requirements and assists users in tracking their daily fluid intake. The control group will be asked to log their water intake for the duration of the study, with requested use of 5 days per week to create an equal control. This application is free to download and use. There are options for in-app purchases and application upgrades, though users will be advised against doing so. Information logged in the application may be stored on a third party server; however, no application data will be extracted by the study team. Application use will be reported via weekly surveys, alone.
Outcome Measures
Primary Outcome Measures :
  1. Post-intervention change in Knee injury and Osteoarthritis Outcome (KOOS) pain subscale [ Time Frame: 0,12, 26, 52, and 104 weeks ]
    The KOOS is a validated knee-specific patient-reported outcome survey designed to assess an individual's perception of their knee pain and associated disability. It has 42 items in 5 separately scored subscales; Pain, other Symptoms, ADL function, Sport and Recreation function, and knee-related Quality of Life (QOL). All items are scored 0-4; for each subscale the scores are transformed to a 0-100 scale (0 representing extreme knee problems and 100 representing no knee problems).


Secondary Outcome Measures :
  1. Change in KOOS subscale scores [ Time Frame: 0,12, 26, 52, and 104 weeks ]
    The KOOS is a validated knee-specific patient-reported outcome survey designed to assess an individual's perception of their knee pain and associated disability. It has 42 items in 5 separately scored subscales; Pain, other Symptoms, ADL function, Sport and Recreation function, and knee-related Quality of Life (QOL). All items are scored 0-4; for each subscale the scores are transformed to a 0-100 scale (0 representing extreme knee problems and 100 representing no knee problems).

  2. Change in Five Facet Mindfulness Questionnaire (FFMQ) outcomes [ Time Frame: 0,12, 26, 52, and 104 weeks ]
    The FFMQ-15 is designed to provide a quantitative evaluation of mindfulness. It is based on five independently developed mindfulness questionnaires.The questionnaire has 39 items. The five facets are: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.

  3. Change in Short Form Health Survey (SF-12) self-reported mental and physical health self-assessments [ Time Frame: 0,12, 26, 52, and 104 weeks ]
    The SF-12 is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

**Patients must be able to get care at Nellis, Scott, or Travis Air Force Base (a military installation) in order to participate in this study**

Inclusion Criteria:

  • Male and female Active Duty members and DoD beneficiaries ages 18-74 years
  • Meet criteria for symptomatic knee osteoarthritis according to the American College of Rheumatology (pain on more than half of the days of the past month during at least one of the following activities: walking, ascending or descending stairs, standing upright, or lying in bed at night)
  • Demonstrate radiographic evidence of OA, with Kellgren and Lawrence (KL) Grade ≥1 as determined by Lead Site Investigator at each study location
  • Must have access to a smartphone with enough memory to download the app My Water Balance or the Mindfulness app

Exclusion Criteria:

  • Intra-articular corticosteroid injection in the 3 months prior to participation in the study.
  • Intra-articular hyaluronic acid/PRP injection in the 6 months prior to participation in the study
  • Medical condition contraindicating moderate aerobic exercise as determined by their physician
  • History of knee surgery in the past 6 months or previous knee arthroplasty
  • Inflammatory joint disease.
  • Current Practice of Mindfulness
  • Non-English-speaking
  • Currently pregnant or planning pregnancy over the study period
  • Enrollment in other clinical research study during the study period
  • Inability to comply with treatment protocol, including participation in the Rx3 Home Exercise Program.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jill M Clark, MBA 7026533298 Jill.M.Clark15.ctr@mail.mil
Contact: Amanda J Crawford, BA 7026532113 amanda.j.crawford.ctr@mail.mil

Locations
Layout table for location information
United States, Illinois
375th Medical Group Recruiting
Scott Air Force Base, Illinois, United States, 62225
Contact: Jill M Clark, MBA/HCM    702-653-3298    jill.m.clark15.ctr@mail.mil   
Sponsors and Collaborators
jilliansylvester
Mike O'Callaghan Military Hospital
375th Medical Group, Scott Air Force Base
Travis AFB 60th Med Group
Investigators
Layout table for investigator information
Principal Investigator: Jillian E Sylvester, MD US Air Force
Tracking Information
First Submitted Date  ICMJE April 30, 2019
First Posted Date  ICMJE May 3, 2019
Last Update Posted Date July 23, 2020
Actual Study Start Date  ICMJE May 2, 2019
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019) 		Post-intervention change in Knee injury and Osteoarthritis Outcome (KOOS) pain subscale [ Time Frame: 0,12, 26, 52, and 104 weeks ]
The KOOS is a validated knee-specific patient-reported outcome survey designed to assess an individual's perception of their knee pain and associated disability. It has 42 items in 5 separately scored subscales; Pain, other Symptoms, ADL function, Sport and Recreation function, and knee-related Quality of Life (QOL). All items are scored 0-4; for each subscale the scores are transformed to a 0-100 scale (0 representing extreme knee problems and 100 representing no knee problems).
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019) 		Post-intervention change in Knee injury and Osteoarthritis Outcome (KOOS) pain subscale [ Time Frame: 0,12, 26, 52, and 104 weeks ]
The KOOS is a validated patient-reported outcome survey designed to assess an individual's perception of their knee pain and associated disability.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • Change in KOOS subscale scores [ Time Frame: 0,12, 26, 52, and 104 weeks ]
    The KOOS is a validated knee-specific patient-reported outcome survey designed to assess an individual's perception of their knee pain and associated disability. It has 42 items in 5 separately scored subscales; Pain, other Symptoms, ADL function, Sport and Recreation function, and knee-related Quality of Life (QOL). All items are scored 0-4; for each subscale the scores are transformed to a 0-100 scale (0 representing extreme knee problems and 100 representing no knee problems).
  • Change in Five Facet Mindfulness Questionnaire (FFMQ) outcomes [ Time Frame: 0,12, 26, 52, and 104 weeks ]
    The FFMQ-15 is designed to provide a quantitative evaluation of mindfulness. It is based on five independently developed mindfulness questionnaires.The questionnaire has 39 items. The five facets are: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
  • Change in Short Form Health Survey (SF-12) self-reported mental and physical health self-assessments [ Time Frame: 0,12, 26, 52, and 104 weeks ]
    The SF-12 is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Change in KOOS subscale scores [ Time Frame: 0,12, 26, 52, and 104 weeks ]
    The KOOS is a validated patient-reported outcome survey designed to assess an individual's perception of their knee pain and associated disability.
  • Change in FFMQ outcomes [ Time Frame: 0,12, 26, 52, and 104 weeks ]
    The FFMQ-15 is designed to provide a quantitative evaluation of mindfulness.
  • Change in SF-12 self-reported mental and physical health self-assessments [ Time Frame: 0,12, 26, 52, and 104 weeks ]
    The SF-12 is a validated assessment of an individual's perception of their physical and mental health-related quality of life.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis
Official Title  ICMJE Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis
Brief Summary This study will investigate if mindfulness training via a smartphone mobile app is effective in improving OA-related knee pain.
Detailed Description The investigator's primary aim in this study is to determine if regular use of a mindfulness application improves pain outcomes in adults with knee osteoarthritis. The investigator's secondary aim is to determine if self-reported Healthcare-Related Quality of Life (HRQoL) scores predict response to mindfulness treatment in OA. The investigators hypothesize that the use of an mHealth intervention for mindfulness training may be an effective adjunct treatment of chronic knee osteoarthritis pain; specifically, that regular use of a mindfulness application will result in a statistically significant reduction in pain outcomes and improvement in physical function as determined by the KOOS scoring system. The investigators also hypothesize that those with lower baseline self-reported HRQoL scores are more likely to see a greater improvement in their pain and function with use of a mindfulness application than those with higher baseline scores.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteo Arthritis Knee
  • Pain
Intervention  ICMJE
  • Device: Intervention -- "Headspace" mindfulness application
    Patients will be provided with a pre-paid 12-week subscription to the mindfulness application, and provided an in-person demonstration on how to use it, and the subscription license code will be recorded for the purposes of tracking use after the conclusion of the study. The intervention group will be asked to use the mindfulness app 10 minutes per day/5 days per week. To standardize Pack usage across all participants, users will be asked to complete the Headspace Essentials", "Pain Management", and "Physical Health" Session Packs.
  • Device: Control -- "My Water Balance" application
    My Water Balance calculates an individual's recommended daily water requirements and assists users in tracking their daily fluid intake. The control group will be asked to log their water intake for the duration of the study, with requested use of 5 days per week to create an equal control. This application is free to download and use. There are options for in-app purchases and application upgrades, though users will be advised against doing so. Information logged in the application may be stored on a third party server; however, no application data will be extracted by the study team. Application use will be reported via weekly surveys, alone.
Study Arms  ICMJE
  • Experimental: Intervention with Mindfulness App (Headspace)
    Patient education regarding osteoarthritis, its natural history, and common treatments plus the mindfulness (intervention) app.
    Intervention: Device: Intervention -- "Headspace" mindfulness application
  • Active Comparator: Control with Water App (My Water Balance)
    Patient education regarding osteoarthritis, its natural history, and common treatments plus the My Water Balance (control) app and provided an in-person demonstration on how to use it.
    Intervention: Device: Control -- "My Water Balance" application
Publications *
  • Ball E, Newton S, Kahan BC, Forbes G, Wright N, Cantalapiedra Calvete C, Gibson HAL, Rogozinska E, Rivas C, Taylor SJC, Birch J, Dodds J. Smartphone App Using Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS): Protocol for a Randomized Feasibility Trial. JMIR Res Protoc. 2018 Jan 15;7(1):e8. doi: 10.2196/resprot.7720.
  • Ball EF, Nur Shafina Muhammad Sharizan E, Franklin G, Rogozińska E. Does mindfulness meditation improve chronic pain? A systematic review. Curr Opin Obstet Gynecol. 2017 Dec;29(6):359-366. doi: 10.1097/GCO.0000000000000417. Review.
  • Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1240-9. doi: 10.1001/jama.2016.2323.
  • Chiesa A, Serretti A. A systematic review of neurobiological and clinical features of mindfulness meditations. Psychol Med. 2010 Aug;40(8):1239-52. doi: 10.1017/S0033291709991747. Epub 2009 Nov 27. Review.
  • Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.
  • Deshpande BR, Katz JN, Solomon DH, Yelin EH, Hunter DJ, Messier SP, Suter LG, Losina E. Number of Persons With Symptomatic Knee Osteoarthritis in the US: Impact of Race and Ethnicity, Age, Sex, and Obesity. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1743-1750. doi: 10.1002/acr.22897. Epub 2016 Nov 3.
  • Fish J, Brimson J, Lynch S. Mindfulness Interventions Delivered by Technology Without Facilitator Involvement: What Research Exists and What Are the Clinical Outcomes? Mindfulness (N Y). 2016;7(5):1011-1023. Epub 2016 Jun 2. Review.
  • Fox SD, Flynn E, Allen RH. Mindfulness meditation for women with chronic pelvic pain: a pilot study. J Reprod Med. 2011 Mar-Apr;56(3-4):158-62.
  • Hootman JM, Helmick CG, Barbour KE, Theis KA, Boring MA. Updated Projected Prevalence of Self-Reported Doctor-Diagnosed Arthritis and Arthritis-Attributable Activity Limitation Among US Adults, 2015-2040. Arthritis Rheumatol. 2016 Jul;68(7):1582-7. doi: 10.1002/art.39692. Review.
  • IHS Markit, The Complexities of Physician Supply and Demand 2017 Update: Projections from 2016 to 2030. Prepared for the Association of American Medical Colleges. Washington, DC: Association of American Medical Colleges. Accessed November 2018.
  • Jafarzadeh SR, Felson DT. Updated Estimates Suggest a Much Higher Prevalence of Arthritis in United States Adults Than Previous Ones. Arthritis Rheumatol. 2018 Feb;70(2):185-192. doi: 10.1002/art.40355. Epub 2018 Jan 3.
  • Kotlarz H, Gunnarsson CL, Fang H, Rizzo JA. Insurer and out-of-pocket costs of osteoarthritis in the US: evidence from national survey data. Arthritis Rheum. 2009 Dec;60(12):3546-53. doi: 10.1002/art.24984.
  • la Cour P, Petersen M. Effects of mindfulness meditation on chronic pain: a randomized controlled trial. Pain Med. 2015 Apr;16(4):641-52. doi: 10.1111/pme.12605. Epub 2014 Nov 7.
  • Lee AC, Harvey WF, Price LL, Morgan LPK, Morgan NL, Wang C. Mindfulness is associated with psychological health and moderates pain in knee osteoarthritis. Osteoarthritis Cartilage. 2017 Jun;25(6):824-831. doi: 10.1016/j.joca.2016.06.017. Epub 2016 Jun 24.
  • Lee AC, Harvey WF, Price LL, Han X, Driban JB, Wong JB, Chung M, McAlindon TE, Wang C. Mindfulness Is Associated With Treatment Response From Nonpharmacologic Exercise Interventions in Knee Osteoarthritis. Arch Phys Med Rehabil. 2017 Nov;98(11):2265-2273.e1. doi: 10.1016/j.apmr.2017.04.014. Epub 2017 May 12.
  • McAlindon TE, LaValley MP, Harvey WF, Price LL, Driban JB, Zhang M, Ward RJ. Effect of Intra-articular Triamcinolone vs Saline on Knee Cartilage Volume and Pain in Patients With Knee Osteoarthritis: A Randomized Clinical Trial. JAMA. 2017 May 16;317(19):1967-1975. doi: 10.1001/jama.2017.5283.
  • Murphy L, Schwartz TA, Helmick CG, Renner JB, Tudor G, Koch G, Dragomir A, Kalsbeek WD, Luta G, Jordan JM. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum. 2008 Sep 15;59(9):1207-13. doi: 10.1002/art.24021.
  • Nazarinasab M, Motamedfar A, Moqadam AE. Investigating mental health in patients with osteoarthritis and its relationship with some clinical and demographic factors. Reumatologia. 2017;55(4):183-188. doi: 10.5114/reum.2017.69778. Epub 2017 Aug 31.
  • Nissen SE, Yeomans ND, Solomon DH, Lüscher TF, Libby P, Husni ME, Graham DY, Borer JS, Wisniewski LM, Wolski KE, Wang Q, Menon V, Ruschitzka F, Gaffney M, Beckerman B, Berger MF, Bao W, Lincoff AM; PRECISION Trial Investigators. Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis. N Engl J Med. 2016 Dec 29;375(26):2519-29. doi: 10.1056/NEJMoa1611593. Epub 2016 Nov 13.
  • Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Rasmussen S. A Randomized, Controlled Trial of Total Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1597-606. doi: 10.1056/NEJMoa1505467.
  • Turner JA, Anderson ML, Balderson BH, Cook AJ, Sherman KJ, Cherkin DC. Mindfulness-based stress reduction and cognitive behavioral therapy for chronic low back pain: similar effects on mindfulness, catastrophizing, self-efficacy, and acceptance in a randomized controlled trial. Pain. 2016 Nov;157(11):2434-2444. doi: 10.1097/j.pain.0000000000000635.
  • Veehof MM, Trompetter HR, Bohlmeijer ET, Schreurs KM. Acceptance- and mindfulness-based interventions for the treatment of chronic pain: a meta-analytic review. Cogn Behav Ther. 2016;45(1):5-31. doi: 10.1080/16506073.2015.1098724. Epub 2016 Jan 28. Review.
  • Wang SX, Ganguli AX, Bodhani A, Medema JK, Reichmann WM, Macaulay D. Healthcare resource utilization and costs by age and joint location among osteoarthritis patients in a privately insured population. J Med Econ. 2017 Dec;20(12):1299-1306. doi: 10.1080/13696998.2017.1377717. Epub 2017 Sep 26.
  • Xie F, Kovic B, Jin X, He X, Wang M, Silvestre C. Economic and Humanistic Burden of Osteoarthritis: A Systematic Review of Large Sample Studies. Pharmacoeconomics. 2016 Nov;34(11):1087-1100. Review.
  • Zangi HA, Mowinckel P, Finset A, Eriksson LR, Høystad TØ, Lunde AK, Hagen KB. A mindfulness-based group intervention to reduce psychological distress and fatigue in patients with inflammatory rheumatic joint diseases: a randomised controlled trial. Ann Rheum Dis. 2012 Jun;71(6):911-7. doi: 10.1136/annrheumdis-2011-200351. Epub 2011 Dec 20.
  • Zautra AJ, Davis MC, Reich JW, Nicassario P, Tennen H, Finan P, Kratz A, Parrish B, Irwin MR. Comparison of cognitive behavioral and mindfulness meditation interventions on adaptation to rheumatoid arthritis for patients with and without history of recurrent depression. J Consult Clin Psychol. 2008 Jun;76(3):408-421. doi: 10.1037/0022-006X.76.3.408.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 30, 2019) 		360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

**Patients must be able to get care at Nellis, Scott, or Travis Air Force Base (a military installation) in order to participate in this study**

Inclusion Criteria:

  • Male and female Active Duty members and DoD beneficiaries ages 18-74 years
  • Meet criteria for symptomatic knee osteoarthritis according to the American College of Rheumatology (pain on more than half of the days of the past month during at least one of the following activities: walking, ascending or descending stairs, standing upright, or lying in bed at night)
  • Demonstrate radiographic evidence of OA, with Kellgren and Lawrence (KL) Grade ≥1 as determined by Lead Site Investigator at each study location
  • Must have access to a smartphone with enough memory to download the app My Water Balance or the Mindfulness app

Exclusion Criteria:

  • Intra-articular corticosteroid injection in the 3 months prior to participation in the study.
  • Intra-articular hyaluronic acid/PRP injection in the 6 months prior to participation in the study
  • Medical condition contraindicating moderate aerobic exercise as determined by their physician
  • History of knee surgery in the past 6 months or previous knee arthroplasty
  • Inflammatory joint disease.
  • Current Practice of Mindfulness
  • Non-English-speaking
  • Currently pregnant or planning pregnancy over the study period
  • Enrollment in other clinical research study during the study period
  • Inability to comply with treatment protocol, including participation in the Rx3 Home Exercise Program.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jill M Clark, MBA 7026533298 Jill.M.Clark15.ctr@mail.mil
Contact: Amanda J Crawford, BA 7026532113 amanda.j.crawford.ctr@mail.mil
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03936088
Other Study ID Numbers  ICMJE FWH20190033H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The investigators do not plan on sharing data
Responsible Party jilliansylvester, 375th Medical Group, Scott Air Force Base
Study Sponsor  ICMJE jilliansylvester
Collaborators  ICMJE
  • Mike O'Callaghan Military Hospital
  • 375th Medical Group, Scott Air Force Base
  • Travis AFB 60th Med Group
Investigators  ICMJE
Principal Investigator: Jillian E Sylvester, MD US Air Force
PRS Account 375th Medical Group, Scott Air Force Base
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药