Testing Utility of Commercially Available Sleep Trackers for Physician-Patient Communication

NCT03795129 | Unknown

• 1 other identifier: Merck - 34
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep related disorders are common in primary care practice. Sleep wear related data has not been utilized to improve sleep related communication between patients and providers. The study team is conducting a randomized study to improve physical-patient communication regarding sleep through a novel intervention based upon sleep wear and the Sleeplife® app.

Conditions

Insomnia

Keywords

Early awakening

Outcome Measures

Primary Outcomes (2)

• Number of physicians using a commercially available sleep tracker assessed by the "Physician Satisfaction/Communication" questionnaire who saw an improvement in physician-patient dialogue regarding sleep and related behaviors and habits

  For patient-physician communications from the physicians' end, the team will collect all scores, ranging from 1 to 5, for all the "Communication" questions in the "Physician Satisfaction/Communication" questionnaire. The scores will be summed up as the total communication score from physician, and the total score will be treated as continuous response variable. Then a binary variable indicating whether the physician is in the intervention (=1) or control (=0) arm will be treated as the main explanatory variable, a continuous variable regarding the time where the measurements are recorded, and the set of general demographic variables (age, race, gender, etc) will be used as covariates. We will use linear regression model, and select relevant variables using Bayesian information criterion (BIC) in a step-wise manner. The SleepLife app will be pulling time-to-sleep (TST), amount of time in minutes to sleep, number of awakenings greater than 5 minutes, and sleep efficiency.

  Six Months

• Number of patient-physician communicationdialog assessed by using a commercially available sleep tracker assessed by the "Patient Satisfaction" questionnaire.

  For patient-physician communications from the patients' end, the team will collect all the scores, ranging from 1 to 5, for all the "Communication" questions in the "Patient Satisfaction" questionnaire. The scores will be summed up as the total communication score from the patients' end, and the total score will be treated as continuous response variable. Then a binary variable indicating whether the patient is in the intervention (=1) or control (=0) arm will be treated as the main explanatory variable, a continuous variable regarding the time where the measurements are recorded, and the set of general demographic variables (age, race, gender, etc) will be used as covariates. Considering the linear responses and the cluster design, the team will use generalized estimating equation (GEE) model with an identity link function, and the team will select relevant variables using QIC in a step-wise manner.

  Six Months

Secondary Outcomes (2)

• Number of physician subjects with satisfaction with sleep counseling that improves when presented with objective patient sleep data.

  Six Months

• Number of patients who feel that their communication with their physician has improved as a result of the program as measured by the "Patient Satisfaction" survey.

  Six Months

Other Outcomes (1)

• To determine if data improves over time for measures related to total sleep time (TST) and satisfaction with sleep.

  Six Months

Study Arms (2)

SleepLife Application w/FitBit

EXPERIMENTAL

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.

Behavioral: SleepLife Application w/FitBit

FitBit w/Minimal to No SleepLife App.

ACTIVE COMPARATOR

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.

Behavioral: FitBit w/Minimal to No SleepLife App.

Interventions

SleepLife Application w/FitBit BEHAVIORAL

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.

SleepLife Application w/FitBit

FitBit w/Minimal to No SleepLife App. BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• and older
• Have insomnia as identified by electronic record and/or a validated questionnaire
• 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)
• \. English speaking 4. Consentable in-person 5. Have access to a telephone with smart phone capabilities. (iOS/Android)

You may not qualify if:

• Not English speaking
• Have ischemic or hemorrhagic cerebrovascular disease affecting collection of study outcomes (via ICD codes I6\*, 43\*)
• History of dementia (via ICD codes F0\*, 290\*)
• History of Bipolar/Schizophrenia/Depression (via ICD codes F2\*, F31\*, 296\*, 295\*)
• History of alcohol or substance abuse (via ICD codes F1\*, 304\*, 303\*)
• Incarcerated/Long Term Care (LTC)
• Unable to complete study questionnaires due to hearing loss or blindness

Sponsors & Collaborators

• Regenstrief Institute, Inc.: lead
• Merck Sharp & Dohme LLC: collaborator
• National Sleep Foundation: collaborator

Study Sites (1)

Regenstrief Institute

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Publications (12)

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  RESULT

• 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.

  PMID: 26684758 RESULT

• 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.

  PMID: 26969518 RESULT

• 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.

  PMID: 26158542 RESULT

• 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.

  PMID: 28709508 RESULT

• Hays, R.D., Davies, A.R., & Ware, J.E. (1987). Scoring the medical outcomes study patient satisfaction questionnaire: PSQ-III. MOS Memorandum.

  RESULT

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  PMID: 17269944 RESULT

• 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.

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  PMID: 5349366 RESULT

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  PMID: 11459715 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Babar Khan, MD

  Regenstrief Institute, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jarod R Baker, MS

CONTACT

317-274-9274; bakerjar@regenstrief.org

Bridget A Fultz

CONTACT

317-274-9088; bafultz@iupui.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking will not occur.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a cluster randomized trial that is randomized at the clinic level.

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: January 7, 2019
• Study Start: June 10, 2018
• Primary Completion: December 31, 2018
• Study Completion: February 28, 2019
• Last Updated: January 7, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)