Testing Utility of Commercially Available Sleep Trackers for Physician-Patient Communication
NCT ID: NCT03795129
Last Updated: 2019-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2018-06-10
2019-02-28
Brief Summary
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Detailed Description
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Commercially available and inexpensive exercise, fitness and sleep trackers are broadly available and consumer use is growing rapidly. Industry analysts estimate that over 30 million Americans have access to their sleep tracking data (e.g. Fitbit. Jawbone). Physicians seldom use patient-generated (i.e. subjective) sleep data (e.g. sleep diaries) and have been slow to integrate objective sleep data collected from commercial sleep trackers. Two commercial sleep trackers have been validated by independent testing. The National Sleep Foundation (NSF) has led recent efforts to establish normative data (i.e. appropriate ranges) for sleep duration and sleep quality. NSF, together with the Consumer Electronics Association (now Consumer Technology Association), has established a work-group involving over 40 sleep tracking technology companies which is working to standardize sleep tracking data collection and reporting. Finally, NSF has developed a tool ("SleepLife") that translates data retrieved from all commercially available sleep trackers into a personal sleep tracking record. This product has been tested rigorously for two years and publicly released in January 2016. These developments present the timely opportunity to test a new paradigm for patient and physician communication using objective patient data (sleep).
The study team will utilize a combination of observational and interventional study designs to achieve study objectives.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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SleepLife Application w/FitBit
Subject receives a FitBit. Subjects receive access to the SleepLife Application. Subjects receive training and assistance setting up use and access to the SleepLife Application.
Subject physicians will receive subject sleep data. Subject and physicians have the option of messaging each other through the SleepLife application.
SleepLife Application w/FitBit
Subjects receive a FitBit. Subjects receive access to the SleepLife Application. Subjects receive training and assistance setting up use and access to the SleepLife Application.
Subjects' physicians will receive subject sleep data. Subjects and physicians have the option of messaging each other through the SleepLife application.
FitBit w/Minimal to No SleepLife App.
Subjects will receive a FitBit Subjects will be told about the SleepLife Application (but not be shown how to access it).
Subjects will receive no training with regard to how to access SleepLife Application.
Subjects' physicians will receive no subject sleep data.
FitBit w/Minimal to No SleepLife App.
Subjects will receive a FitBit. Subjects will be told about the SleepLife Application (but not be shown how to access it).
Subjects will receive no training with regard to how to access SleepLife Application.
Subjects' physicians will receive no subject sleep data.
Interventions
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SleepLife Application w/FitBit
Subjects receive a FitBit. Subjects receive access to the SleepLife Application. Subjects receive training and assistance setting up use and access to the SleepLife Application.
Subjects' physicians will receive subject sleep data. Subjects and physicians have the option of messaging each other through the SleepLife application.
FitBit w/Minimal to No SleepLife App.
Subjects will receive a FitBit. Subjects will be told about the SleepLife Application (but not be shown how to access it).
Subjects will receive no training with regard to how to access SleepLife Application.
Subjects' physicians will receive no subject sleep data.
Eligibility Criteria
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Inclusion Criteria
2. Have insomnia as identified by electronic record and/or a validated questionnaire
3. Prescription medication for insomnia with International Classification of Disease (ICD) codes: 327.\*, 780.5\*, 347.\*; icd-10's G47\* and medications: Ambien (zolpidem), Belsomra (suvorexant), Butisol (butabarbital), Doral (quazepam), Edluar (zolpidem), Estazolam, Flurazepam, Halcion (triazolam), Hetlioz (tasimelteon), Intermezzo (zolpidem), Lunesta (eszopiclone), Restoril (temazepam), Rozerem (ramelteon), Seconal (secobarbital), Silenor (doxepin), Sonata (zaleplon), and Zolpimist (zolpidem)
3\. English speaking 4. Consentable in-person 5. Have access to a telephone with smart phone capabilities. (iOS/Android)
Exclusion Criteria
2. Have ischemic or hemorrhagic cerebrovascular disease affecting collection of study outcomes (via ICD codes I6\*, 43\*)
3. History of dementia (via ICD codes F0\*, 290\*)
4. History of Bipolar/Schizophrenia/Depression (via ICD codes F2\*, F31\*, 296\*, 295\*)
5. History of alcohol or substance abuse (via ICD codes F1\*, 304\*, 303\*)
6. Incarcerated/Long Term Care (LTC)
7. Unable to complete study questionnaires due to hearing loss or blindness
18 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
National Sleep Foundation
OTHER
Regenstrief Institute, Inc.
OTHER
Responsible Party
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Principal Investigators
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Babar Khan, MD
Role: PRINCIPAL_INVESTIGATOR
Regenstrief Institute, Inc.
Locations
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Regenstrief Institute
Indianapolis, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Fox S, & Duggan M. Tracking for health. Pew Research Center, Pew Internet and American Life Project. 2013.
Evenson KR, Goto MM, Furberg RD. Systematic review of the validity and reliability of consumer-wearable activity trackers. Int J Behav Nutr Phys Act. 2015 Dec 18;12:159. doi: 10.1186/s12966-015-0314-1.
de Zambotti M, Baker FC, Willoughby AR, Godino JG, Wing D, Patrick K, Colrain IM. Measures of sleep and cardiac functioning during sleep using a multi-sensory commercially-available wristband in adolescents. Physiol Behav. 2016 May 1;158:143-9. doi: 10.1016/j.physbeh.2016.03.006. Epub 2016 Mar 9.
de Zambotti M, Claudatos S, Inkelis S, Colrain IM, Baker FC. Evaluation of a consumer fitness-tracking device to assess sleep in adults. Chronobiol Int. 2015;32(7):1024-8. doi: 10.3109/07420528.2015.1054395.
Knutson KL, Phelan J, Paskow MJ, Roach A, Whiton K, Langer G, Hillygus DS, Mokrzycki M, Broughton WA, Chokroverty S, Lichstein KL, Weaver TE, Hirshkowitz M. The National Sleep Foundation's Sleep Health Index. Sleep Health. 2017 Aug;3(4):234-240. doi: 10.1016/j.sleh.2017.05.011. Epub 2017 Jun 20.
Hays, R.D., Davies, A.R., & Ware, J.E. (1987). Scoring the medical outcomes study patient satisfaction questionnaire: PSQ-III. MOS Memorandum.
Campbell C, Lockyer J, Laidlaw T, Macleod H. Assessment of a matched-pair instrument to examine doctor-patient communication skills in practising doctors. Med Educ. 2007 Feb;41(2):123-9. doi: 10.1111/j.1365-2929.2006.02657.x.
Charlson ME, Sax FL, MacKenzie CR, Fields SD, Braham RL, Douglas RG Jr. Resuscitation: how do we decide? A prospective study of physicians' preferences and the clinical course of hospitalized patients. JAMA. 1986 Mar 14;255(10):1316-22. doi: 10.1001/jama.255.10.1316.
KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
D'Hoore W, Sicotte C, Tilquin C. Risk adjustment in outcome assessment: the Charlson comorbidity index. Methods Inf Med. 1993 Nov;32(5):382-7.
Herr KA, Garand L. Assessment and measurement of pain in older adults. Clin Geriatr Med. 2001 Aug;17(3):457-78, vi. doi: 10.1016/s0749-0690(05)70080-x.
Other Identifiers
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Merck - 34
Identifier Type: -
Identifier Source: org_study_id
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