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. 2019 Sep 26;8(9):e14665. doi: 10.2196/14665

Table 1.

Variables and measures.

Categories and variables (frequency/source) Definition
Demographic and baseline clinical characteristics (once at registration/ArthritisPower)

Age
  • Date of birth


Gender
  • Male or female


Race
  • American Indian or Alaskan Native, Asian, Black or African American, Native Hawaiian or other Pacific Islander, Caucasian, multiple race, RTAa


Hispanic ethnicity
  • No, unknown, yes


Zip code
  • 5-digit US postal code


Condition(s)
  • Rheumatoid arthritis


Years since RAb diagnosis c

Rheumatologist name
  • National Provider Identifier lookup by city, state


Height

Weight

Current medications, supplements, vitamins, over the counter, and other nonprescription remedies
  • DMARDd medication class for all medications taken for the treatment of RA. This attribute serves as confirmation of self-reported RA as well as a baseline covariate.


Telephone number (cellular)

Preference for email versus text notifications and reminders

Typical work schedule

Typical sleep schedule
ePROe measures

Pain, single-item NRSf (daily/ArthritisPower)
  • 0 (no pain) - 10 (pain as bad as it could be) at 0.5 intervals


Fatigue, single-item NRS (daily/ArthritisPower)
  • 0 (no fatigue) - 10 (worst possible fatigue) at 0.5 intervals


PROMIS-CATg Fatigue (weekly/ArthritisPower)
  • 0-100 t-score; 0 - <55 (within normal limits), 55 - <60 (mild), 60 - <70 (moderate), ≥70 (severe)


PROMIS-CAT Pain Interference (weekly/ArthritisPower)
  • 0-100 t-score; 0 - <55 (within normal limits), 55 - <60 (mild), 60 - <70 (moderate), ≥70 (severe)


PROMIS-CAT Physical Function (weekly/ArthritisPower)
  • 0-100 t-score; ≥55 (within normal limits), 40 - <55 (mild), 30 - <40 (moderate), <30 (severe)


PROMIS-CAT Satisfaction with Participation in Discretionary Social Activities (weekly/ArthritisPower)
  • 0-100 t-score; ≥55 (within normal limits), 40 - <55 (mild), 30 - <40 (moderate), <30 (severe)


PROMIS-CAT Sleep Disturbance (weekly/ArthritisPower)
  • 0-100 t-score; 0 - <55 (within normal limits), 55 - <60 (mild), 60 - <70 (moderate), ≥70 (severe)



OMERACTh RA Flare (weekly/ArthritisPower)
  • 0 (low) - 50 (high)


Godin Leisure-Time Physical Activity Questionnaire (weekly/ArthritisPower)
  • 0-23 (insufficiently active), ≥24 (active)


Adherence to ePRO measure completion (daily or weekly/ArthritisPower)
  • Ratio of completed ePROs to number of required ePROs prior to discontinuation or end of study period


Persistence with ePRO measure completion (daily or weekly/ArthritisPower)
  • Days until first incomplete or missing ePRO within study period

Passively collected biosensor data (continuous [if smartwatch is synced every <5 days]/Fitabase)

Activity
  • Steps (minute, hour, day)

  • Activity intensity (minute, hour, day)

  • Distance (day) - units = miles

  • Energy expenditure (minute, hour, day)

  • Metabolic Equivalents (minute)


Activity-derived variables
  • Time walking per day (minutes)

  • Time in activity intensity categories per day (minutes)

  • Active time (minutes)

  • Aerobic time (minutes)


Heart rate
  • Beats per minute (minute, day)


Heart rate–derived variables
  • Time in heart rate zone of interest based on exercise charts


Sleep
  • Time sleeping in last 24 hours (minute, day)


Sleep-derived variables
  • Time in light, deep, and REMi sleep and time to sleep onset, time awake and other derived variables (day)


Adherence to wearing and syncing smartwatch
  • Ratio of days with smartwatch data to number of days during study period prior to discontinuation or end of study period


Persistence with wearing and syncing smartwatch
  • Days until first day without any smartwatch data in Fitabase

aRTA: refuse to answer.

bRA: rheumatoid arthritis.

cNot applicable.

dDMARD: Disease-Modifying Antirheumatic Drug.

eePRO: electronic patient-reported outcome.

fNRS: numeric rating scale.

gPROMIS-CAT: Patient-reported outcome measurement information system-computer adaptive testing.

hOMERACT: Outcome Measures in Rheumatology.

iREM: rapid eye movement.