Row | Reporting Item | SPIRIT Item | Details |
1 | Trial registration | #2a, #2b | clinicaltrial.gov, NCT03109210, registered on April 12, 2017 |
2 | Protocol version | #3 | 25 Mar 2020. Version 2, updated to add remote visit procedures in adaptation to COVID-19 pandemic |
3 | Funding | #4 | National Heart Lung and Blood Institute, R01HL130559, 9/1/2016-6/30/2022 |
4 | Author details | #5a |
Elizabeth Devon Eldridge-Smith, PhD smithed@njhealth.org National Jewish Health 1400 Jackson St, Denver, CO 80206, USA Rachel Manber, PhD rmanber@stanford.edu Stanford University 401 Quarry Road, Stanford, CA 94305, USA Jack Edinger, PhD edingerj@njhealth.org National Jewish Health 1400 Jackson St, Denver, CO 80206, USA Bryan Simmons, MS simmonsb@njhealth.org National Jewish Health 1400 Jackson St, Denver, CO 80206, USA Matthew Strand, PhD strandm@njhealth.org National Jewish Health 1400 Jackson St, Denver, CO 80206, USA Sheila Tsai, PhD tsais@njhealth.org National Jewish Health 1400 Jackson St, Denver, CO 80206, USA Roxane Horberg, MPH horbergr@njhealth.org National Jewish Health 1400 Jackson St, Denver, CO 80206, USA Ann Depew, MA, LPC depewa@njhealth.org National Jewish Health 1400 Jackson St, Denver, CO 80206, USA Rachel Johnson, MA johnsonr@njhealth.org National Jewish Health 1400 Jackson St, Denver, CO 80206, USA Aysha Abraibesh, MPA aysha.abraibesh@stanford.edu Stanford University 401 Quarry Road, Stanford, CA 94305, USA Norah Simpson, PhD nsimpson@stanford.edu Stanford University 401 Quarry Road, Stanford, CA 94305, USA Colin A. Espie, PhD, DSc colin@bighealth.com Big Health 461 Bush St #200, San Francisco, CA 94108, USA University of Oxford Oxford OX1 2JD, United Kingdom Clete Kushida, MD, PhD clete@stanford.edu Stanford University 450 Broadway Street, Redwood City CA |
5 | Sponsor contact information | #5b |
Louis Velasco, Grants Management Specialist, (301) 827-7977, louis.velasco@nih.gov |
6 | Role of sponsor | #5c | The sponsor/funding source is not involved in study design, data collection and analysis, interpretation, writing of the report, or decision to submit for publication |
7 | Role of committees | #5d |
Principal investigator and research physician: Oversight of trial, including supervision of study personnel. Reviewing progress of study and if necessary agreeing changes to the protocol to facilitate the smooth running of the study Responsible for trial master files Study therapists: Delivery of cognitive behavioral therapy in accordance with study protocol Site coordinating teams (project manager, study coordinators): Preparation of protocol and revisions Preparation and submission of regulatory paperwork Reporting to pertinent IRBs Organization of study meetings Creation of study reports Recruitment Study coordination and data collection in adherence to study protocol. Research administration: Grant finance management Contract development and maintenance Data team (Study statistician, study coordinators): Preparation of routine data audit reports Data verification Randomization Maintenance of trial data collection system and data entry surveillance |
8 | Auditing | #23 | Regulatory oversight is completed through a yearly review of progress completed by the Institutional Review Board of record. Additionally, the study has a Data and Safety Monitoring Board comprised of three sleep medicine experts, which also meets once per calendar year to review the progress of the study and consult on issues related to ethical conduct. |
9 | Authorship policy | #31b | Topics suggested for presentation or publication will be circulated to the PIs. The PI of an ancillary study should be considered for lead author of material derived from this study. PIs will be consulted to suggest and justify names for authors. |