Chronic PainNCT03299556
Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System
An observational study of Chronic Pain, run by Purdue Pharma LP at 1 site in United States.
Trial summary
This is a proof of concept study to measure the effect of Wearable Health Technology (WHT), including the Apple Watch, iPhone, Pain App and Provider Dashboards on important clinical outcomes in patients treated for chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- WHT
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2017to 30 Nov 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Geisinger chronic pain patients, currently or previously enrolled in the MPP or currently receiving treatment in the MPM program.
Who may be able to join
- Admission to the MPP
- Completion of the 3-day MPP training
- Ability to understand and complete the informed consent form prior to the initiation of any study procedures
- Adequate motor skills needed to utilize WHT
- Willingness to utilize personal electronic devices and WHT, as expressed and documented during the informed consenting process
- Ability to understand spoken and written English
Who cannot join
- Cancer diagnosis, AIDS, end-stage liver disease or end-stage renal disease
- Hospitalization >30 days during the 12 months prior to Index Date
- Nursing home or hospice care during the 12 months prior to Index Date
- Presence of an EHR Diagnosis description "OPT-OUT CENTER RESEARCH" which indicates the subject has opted out of (i.e., does not wish to be included in) any Geisinger retrospective research
- Has a terminated Medicine Use Agreement on their Problem List, indicator for substance abuse/dependence
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Health System
Danville, Pennsylvania, 17822
About this study
This is a proof of concept study to measure the effect of Wearable Health Technology (WHT), including the Apple Watch, iPhone, Pain App and Provider Dashboards on important clinical outcomes in patients treated for chronic pain. WHT will be tested in a group of chronic pain patients treated at a specialty pain clinic, the Geisinger Multidisciplinary Pain Program (MPP). Primary and secondary outcomes include pain, physical function, depression, pain medicine use, amount of sleep, activity levels, healthcare resource utilization and cost. The WHT will collect self-reported data on pain, pain management therapies, and medication utilization, and passively collected data on subject activity levels and sleep. Additional data will be collected on device utilization by patients and health care professionals.
Read the detailed description
This is a prospective, non-randomized, non-blinded trial with historic and concurrent controls to assess the effect of the addition of WHT on patient and health system outcomes. WHT used in this study are the Apple Watch and iPhone, a pain application (Pain App) designed specifically for this study to be used with the watch and phone, and physician and patient dashboards also designed for this study to provide subjects and health care providers data displays of information captured by the WHT.
The WHT will consist of:
- AppleWatch and iPhone
- Patient and provider tracking of patient-reported pain, pain management, medication usage, functionality, depression, activity and sleep (measured by 3 axis actigraph)
- Prompts to subjects to engage in self-care, including non-pharmaceutical pain management therapies consistent with MPP training
Subjects will use the WHT 20 hours per day, every day for a period of 12 months.
Subjects will attend study visits at baseline and months 2, 4, 6, 8, 10 and 12.
Outcome data for control groups will be collected retrospectively from the electronic health record (EHR). Assessments will have occurred as part of their standard of care.
- Conditions
- Chronic Pain
- Being tested
- WHT
- Keywords
- Wearable Health Technology, iPhone, Apple Watch, Pain Medication
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHTOther
Incorporating WHT into treatment for chronic pain. WHT includes patient and provider tracking of patient-reported pain, pain management, medication usage, functionality, depression, activity and sleep (measured by 3 axis actigraph); as well as prompts to subjects to engage in self-care, including non-pharmaceutical pain management therapies consistent with MPP training.
| Study group | Role | What they receive |
|---|---|---|
| WHT | The WHT group includes only patients newly enrolled in the Geisinger MPP program who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up. Receives: Other: WHT | |
| Historic Control | Patients who were enrolled in the MPP in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment. | |
| Concurrent Control | Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Score (NPS)
self reported 11-point pain scale. The numeric pain score (NPS) is self-reported by the patient on a scale of 0 to 10, with the following scale labels: no pain (0), mild pain (2), moderate pain (4), severe pain (6), very severe pain (8), and worst pain possible (10).
Measured: Baseline, 12-month follow-up
Patient Health Questionnaire (PHQ-9)
self reported measurement of depression. The scale ranges from 0 to 27, indicating the following levels of depression severity: none (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).
Measured: Baseline, 12-month follow-up
Mean Daily Morphine Equivalents (MEQs)
calculated from health records, average amount of daily pain medication [as measured by the daily milligrams of morphine equivalents (MME)].
Measured: Baseline, 12-month follow-up
Secondary outcomes (1)
Oswestry Disability Index (ODI)
self reported measure of functionality, related to back and neck pain. The ODI is a self-administered questionnaire assessing symptoms and severity of back or neck pain on a scale from 0 to 100. This measurement evaluates the loss of function in activities of daily living. Two ODI questionnaires were used in this study, one for neck pain and one for back pain. Interpretation of ODI scoring is as follows: minimal disability (0-20), moderate disability (21-40), severe disability (41-60), and crippled (61-80). Scores over 80 suggest the patient may be bedbound or exaggerating their symptoms and careful evaluation is recommended.
Measured: Baseline, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start5 Oct 2017
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Geisinger Clinic
- Responsible party
- Sponsor
- Investigators
- Thomas Alfieri, PhD, Study director, Purdue Pharma LPJohn J Han, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299556
- Sponsor's protocol ID
- 2017-0196
- Status last verified
- Apr 2024
- First submitted
- 27 Sep 2017
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System
- ClinicalTrials.gov ID
- NCT03299556
- Acronym / sponsor ID
- 2017-0196
- Conditions
- Chronic Pain
- Keywords
- Wearable Health Technology, iPhone, Apple Watch, Pain Medication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Collaborators
- Geisinger Clinic
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a proof of concept study to measure the effect of Wearable Health Technology (WHT), including the Apple Watch, iPhone, Pain App and Provider Dashboards on important clinical outcomes in patients treated for chronic pain. WHT will be tested in a group of chronic pain patients treated at a specialty pain clinic, the Geisinger Multidisciplinary Pain Program (MPP). Primary and secondary outcomes include pain, physical function, depression, pain medicine use, amount of sleep, activity levels, healthcare resource utilization and cost. The WHT will collect self-reported data on pain, pain management therapies, and medication utilization, and passively collected data on subject activity levels and sleep. Additional data will be collected on device utilization by patients and health care professionals.
Detailed description
This is a prospective, non-randomized, non-blinded trial with historic and concurrent controls to assess the effect of the addition of WHT on patient and health system outcomes. WHT used in this study are the Apple Watch and iPhone, a pain application (Pain App) designed specifically for this study to be used with the watch and phone, and physician and patient dashboards also designed for this study to provide subjects and health care providers data displays of information captured by the WHT.
The WHT will consist of:
- AppleWatch and iPhone
- Patient and provider tracking of patient-reported pain, pain management, medication usage, functionality, depression, activity and sleep (measured by 3 axis actigraph)
- Prompts to subjects to engage in self-care, including non-pharmaceutical pain management therapies consistent with MPP training
Subjects will use the WHT 20 hours per day, every day for a period of 12 months.
Subjects will attend study visits at baseline and months 2, 4, 6, 8, 10 and 12.
Outcome data for control groups will be collected retrospectively from the electronic health record (EHR). Assessments will have occurred as part of their standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WHT | – | Other: WHTThe WHT group includes only patients newly enrolled in the Geisinger MPP program who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up. |
| Historic Control | – | –Patients who were enrolled in the MPP in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment. |
| Concurrent Control | – | –Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Geisinger chronic pain patients, currently or previously enrolled in the MPP or currently receiving treatment in the MPM program.
Key inclusion criteria (6 listed)
- Admission to the MPP
- Completion of the 3-day MPP training
- Ability to understand and complete the informed consent form prior to the initiation of any study procedures
- Adequate motor skills needed to utilize WHT
- Willingness to utilize personal electronic devices and WHT, as expressed and documented during the informed consenting process
Key exclusion criteria (5 listed)
- Cancer diagnosis, AIDS, end-stage liver disease or end-stage renal disease
- Hospitalization >30 days during the 12 months prior to Index Date
- Nursing home or hospice care during the 12 months prior to Index Date
- Presence of an EHR Diagnosis description "OPT-OUT CENTER RESEARCH" which indicates the subject has opted out of (i.e., does not wish to be included in) any Geisinger retrospective research
- Has a terminated Medicine Use Agreement on their Problem List, indicator for substance abuse/dependence
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 |
|---|---|---|
| WHTIncorporating WHT into treatment for chronic pain. WHT includes patient and provider tracking of patient-reported pain, pain management, medication usage, functionality, depression, activity and sleep (measured by 3 axis actigraph); as well as prompts to subjects to engage in self-care, including non-pharmaceutical pain management therapies consistent with MPP training. | Other | WHT |
Primary outcome
Numerical Pain Score (NPS)
Time frame: Baseline, 12-month follow-up
self reported 11-point pain scale. The numeric pain score (NPS) is self-reported by the patient on a scale of 0 to 10, with the following scale labels: no pain (0), mild pain (2), moderate pain (4), severe pain (6), very severe pain (8), and worst pain possible (10).
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 12-month follow-up
self reported measurement of depression. The scale ranges from 0 to 27, indicating the following levels of depression severity: none (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).
Mean Daily Morphine Equivalents (MEQs)
Time frame: Baseline, 12-month follow-up
calculated from health records, average amount of daily pain medication [as measured by the daily milligrams of morphine equivalents (MME)].
1 secondary outcome
Oswestry Disability Index (ODI)
Time frame: Baseline, 12-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Long-term Use of Wearable Health Technology by Chronic Pain PatientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Thomas Alfieri, PhD study director
Purdue Pharma LP
John J Han, MD principal investigator
Geisinger Clinic
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 Purdue Pharma LP 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Numerical Pain Score (NPS) (time frame: Baseline, 12-month follow-up). The study lists 3 primary outcomes in all. 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 19 Sep 2024.