Clinical trial NCT02447107: Mobile Phone Technology for Chronic Pain Patients- A Feasibility Study
Official title: The Utilization of Mobile Phone Technology to Quantitatively Assess Functional Outcomes of Chronic Pain Patients- A Feasibility Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Pain
Keywords: Chronic Pain
Technology
Mobile Phone Applications
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2015-05-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All study subjects will be chronic pain patients being treated for moderate to severe chronic pain

Brief summary: Mobile technology can be used to passively capture data tracing features and fluctuations of patients' daily activities, including activity levels, location patterns, sleep, and a wide variety of other health-relevant metrics. This data can then be combined with contextual recall, collected through a mobile app, to enhance passively captured behavioral data. The resulting data collection is objective, real-time, and contextual, thus addressing the pitfalls of conventional measurement of pain treatment outcomes.

Detailed description: The goal of this pilot study is to assess the feasibility and value of using smart phone applications to collect objective, quantitative functional data from patients under active treatment for chronic pain.

35 subjects will be enrolled from the Weill Cornell Pain Medicine Center to ensure a total of 30 completed sets of surveys (15 males, 15 females). The Chronic Pain Registry (a data registry utilized to assess the outcomes of chronic pain patients) will provide data regarding the patients' demographics, diagnosis, and prescribed medications. The mobile applications ("Mobility" and "Ohmage") will be downloaded in the office with a demonstration of proper use. "Ohmage" is a data collection application, designed for use on a smart phone or tablet, and allows for both passive and active capture of data via a device's internal sensing mechanisms and through a user's participation in surveys. "Mobility" is a mobile phone sensor application, designed for both android and iPhone devices, that allows a phone to passively capture information about its user's activity. The "Mobility" application uses an activity classifier algorithm to determine if the user is stationary, walking, running, or driving based on how quickly the WiFi and/or GPS signals change, coupled with the strength of motion detected by the phone's internal accelerometer. Ohmage aggregates the Mobility application's generated data and uploads the data to a secure server for study and analysis. Patients will be asked to keep a daily electronic diary via the Ohmage app. Mobility will be used to track the patients' movement and level of activity. Telephone assistance will be available in case of technical problems (Monday to Friday, 9AM-5PM). An audible alarm reminder will be programmed to encourage compliance with use as well as timely completion of the compliance diary.

Two iterative usability cycles will be conducted with assessment of the compliance diary and questionnaire administration at the 1 and 2-week endpoints.

Eligibility criteria: Inclusion Criteria:

* Patients with eligible smart phone devices (iPhones and Androids- working, newer models (released in the last 3 years)) running a sufficient, current version of iOS or Android
* Chronic low back pain (at least 3 months) with or without lower extremity pain (i.e. lumbar radiculopathy, spinal stenosis)
* Average pain is rated at least moderate (numerical score greater than or equal to 5/10)
* Ages 18 - 65 years
* Participating in Chronic Pain Registry (standard of care)

Exclusion Criteria:

* Conditions limiting mobility
* Non-ambulatory (wheelchair bound)
* Movement or neuromuscular disorders
* Significant lower extremity weakness
* Severe cardiorespiratory disease
* Moderate to severe cognitive impairment
* Active cancer therapy (chemotherapy or radiation) in the last year
* Major surgery in the last 3 months
* Inability to comply with study requirements per investigator judgement

Primary outcomes:
measure: Feasibility (measured by adequate enrollment and compliance)
timeFrame: 2 weeks
Secondary outcomes:
measure: Patient Satisfaction (demonstrated by questionnaires)
timeFrame: 2 weeks
measure: Compliance (reasons patients turned their phone off, or did not keep the smart phone on them)
timeFrame: 2 weeks
measure: Demographics
timeFrame: 2 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Pain Medicine Center
state: New York
Study officials:
affiliation: Weill Cornell Medical College Department of Anesthesiology
name: Lisa R Witkin, MD
role: PRINCIPAL_INVESTIGATOR
References: