Chronic PainNCT02447107
Mobile Phone Technology for Chronic Pain Patients- A Feasibility Study
An observational study of Chronic Pain, run by Weill Medical College of Cornell University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Electronic Diary and Questionnaire
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2015to 1 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All study subjects will be chronic pain patients being treated for moderate to severe chronic pain
Who may be able to join
- 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)
Who cannot join
- Conditions limiting mobility
- Non-ambulatory (wheelchair bound)
- Movement or neuromuscular disorders
- Significant lower extremity weakness
- Severe cardiorespiratory disease
- Moderate to severe cognitive impairment
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Pain Medicine Center
New York, New York, 10021
About this study
Official title: The Utilization of Mobile Phone Technology to Quantitatively Assess Functional Outcomes of Chronic Pain Patients- A Feasibility Study
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Electronic Diary, Questionnaire
- Keywords
- Chronic Pain, Technology, Mobile Phone Applications
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic DiaryOther
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.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Electronic Diary; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (3)
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.
Measured: 2 weeks
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.
Measured: 2 weeks
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study start1 May 2015
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Why it stopped: Study feasibility issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa R Witkin, MD, Principal investigator, Weill Cornell Medical College Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447107
- Sponsor's protocol ID
- 1409015460
- Status last verified
- Nov 2017
- First submitted
- 13 May 2015
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utilization of Mobile Phone Technology to Quantitatively Assess Functional Outcomes of Chronic Pain Patients- A Feasibility Study
- ClinicalTrials.gov ID
- NCT02447107
- Acronym / sponsor ID
- 1409015460
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Technology, Mobile Phone Applications
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study feasibility issues
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 18 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatients | – | Other: Electronic Diary, Other: QuestionnaireOutpatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All study subjects will be chronic pain patients being treated for moderate to severe chronic pain
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- Conditions limiting mobility
- Non-ambulatory (wheelchair bound)
- Movement or neuromuscular disorders
- Significant lower extremity weakness
- Severe cardiorespiratory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic DiaryThe 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. | Other | Outpatients |
| QuestionnaireStudy 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. | Other | Outpatients |
Primary outcome
Feasibility (measured by adequate enrollment and compliance)
Time frame: 2 weeks
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.
3 secondary outcomes
Patient Satisfaction (demonstrated by questionnaires)
Time frame: 2 weeks
Compliance (reasons patients turned their phone off, or did not keep the smart phone on them)
Time frame: 2 weeks
Demographics
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: Study feasibility issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa R Witkin, MD principal investigator
Weill Cornell Medical College Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study feasibility issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (measured by adequate enrollment and compliance) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.