Mobile Phone Technology for Chronic Pain Patients- A Feasibility Study

NCT02447107 | Terminated

• 1 other identifier: 1409015460
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Chronic Pain; Technology; Mobile Phone Applications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient Satisfaction (demonstrated by questionnaires)

  2 weeks

• Compliance (reasons patients turned their phone off, or did not keep the smart phone on them)

  2 weeks

• Demographics

  2 weeks

Study Arms (1)

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.

Other: Electronic Diary; Other: Questionnaire

Interventions

Electronic Diary 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.

Outpatients

Questionnaire 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.

Outpatients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All study subjects will be chronic pain patients being treated for moderate to severe chronic pain

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Pain Medicine Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Lisa R Witkin, MD

  Weill Cornell Medical College Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 18, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)