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Mobile Phone Technology for Chronic Pain Patients- A Feasibility Study

NCT ID: NCT02447107

Last Updated: 2017-11-06

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-01

Study Completion Date

2017-11-01

Brief Summary

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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

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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.

Conditions

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Chronic Pain

Keywords

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Chronic Pain Technology Mobile Phone Applications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Outpatients

Outpatients enrolled in this study are required to complete study assessments on mobile applications and through questionnaires. A daily electronic diary will be completed through the Ohmage app. The Mobility app will be used to track the patients' movement and activity. Patients will be administered a questionnaire at the 1 and 2 week endpoints.

Electronic Diary

Intervention Type OTHER

The electronic diary asks subjects questions about their compliance with mobile application usage. The questions contained in this diary ask patients how often their personal mobile device has been on their person, if and how long the applications relevant to the study were turned off, and why patients failed to comply with study requirements.

Questionnaire

Intervention Type OTHER

Study patients will be asked to complete a questionnaire at the 1 and 2-week endpoints. This questionnaire is administered in order to measure patient satisfaction with the mobile applications.

Interventions

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Electronic Diary

The electronic diary asks subjects questions about their compliance with mobile application usage. The questions contained in this diary ask patients how often their personal mobile device has been on their person, if and how long the applications relevant to the study were turned off, and why patients failed to comply with study requirements.

Intervention Type OTHER

Questionnaire

Study patients will be asked to complete a questionnaire at the 1 and 2-week endpoints. This questionnaire is administered in order to measure patient satisfaction with the mobile applications.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa R Witkin, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell Medical College Department of Anesthesiology

Locations

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Weill Cornell Pain Medicine Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1409015460

Identifier Type: -

Identifier Source: org_study_id