Mobile Phone Technology for Chronic Pain Patients- A Feasibility Study

Chronic Pain Clinical Trial

Official title:

The Utilization of Mobile Phone Technology to Quantitatively Assess Functional Outcomes of Chronic Pain Patients- A Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02447107
• Other study ID #: 1409015460
• Status: Terminated
• Phase: N/A
• First received: May 13, 2015
• Last updated: November 2, 2017
• Start date: May 1, 2015
• Est. completion date: November 1, 2017

Study information

• Verified date: November 2017
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Weill Cornell Pain Medicine Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (measured by adequate enrollment and compliance)	The primary objective is to demonstrate that this mobile technology application is feasible as . The compliance threshold for feasibility is defined as at least 50% of patients report diaries showing they had their mobile device powered on, with the app running (raw data), and the phone physically on them for a total of 12 hours per day on average. This will be calculated over the first week of data collected, second week of data, and then also the combined 2 weeks of data.	2 weeks
Secondary	Patient Satisfaction (demonstrated by questionnaires)	Measure outcomes related to the usability and patient satisfaction with the mobile application, as demonstrated by questionnaires at the 1-week and 2-week endpoints.	2 weeks
Secondary	Compliance (reasons patients turned their phone off, or did not keep the smart phone on them)	We will explore the reasons patients turned their phone off, or did not keep the smart phone on them, all of which would be necessary for accurate data capture.	2 weeks
Secondary	Demographics	We will analyze the population of patients who were eligible for the study but declined enrollment, as well as identifying specific subpopulations of patients who had difficulty with compliance, dropped out, or who had low satisfaction and usability scores.	2 weeks