Chronic PainOWLNCT02788539
Our Whole Lives: Online Chronic Pain Management
A study testing Our Whole Lives Website in people with Chronic Pain, run by Boston Medical Center at 1 site in United States.
Trial summary
This project will work to increase knowledge about the utility of a website for management of chronic pain, Our Whole Lives (OWL). It will do so by examining barriers and facilitators to patient use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Our Whole Lives Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jan 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Pilot Cohort Study- Chronic pain greater than or equal to 4 on a 0-10 scale for a least 12 weeks
- For Pilot Cohort Study- English comprehension sufficient to provide informed consent and understand website information.
Who cannot join
- For Pilot Cohort Study: Pregnant or planning to become pregnant in the next 3 months.
- For Pilot Cohort Study- Does not currently have access to the internet
- For Pilot Cohort Study- Begun a new pain treatment in the past month or plans to begin new pain treatments in the next 3 months.
- For Pilot Cohort Study- Does not have an internet enabled device he/she could use to access the website
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Disparities in the Treatment of Chronic Pain Using an Innovative mHealth Tool
This project will work to increase knowledge about the utility of a website for management of chronic pain, Our Whole Lives (OWL). It will do so by examining barriers and facilitators to patient use. In order to gather this information, the investigators will conduct a Science Cafe with 30 individuals (including participants with chronic pain, who have family members with chronic pain or are a stakeholder in the chronic pain community) to gather feedback about how to tailor the OWL website to their needs and preferences and how to improve ease of use for this tool. The investigators will also pilot two cohorts with 40 patients with chronic pain (2 groups of 20 patients) with OWL, the patient-centered, mobile health chronic pain management resource, measuring pain impact (pain severity, pain interference, physical function) and pain associated outcomes (e.g., depression, anxiety, fatigue, sleep disturbance, ability to participate in social roles and activities, pain self-efficacy, health education impact and internalized stigma related to chronic pain).
Read the detailed description
During the first 4 months, conduct a science café targeting 30 individuals/families who live with chronic pain and reside in Boston's low-income, ethnically diverse neighborhoods, in order to: a) gather feedback about how to tailor the OWL curriculum based on their needs and preferences, and b) identify potential enhancements to the mobile technology to improve ease of use. For the science cafe, the investigators will use social media (facebook, twitter, listservs, etc.) to invite the community to meet for a two-hour dialog. . Each participant will be paid for attending, refreshments will be served, and a small thank you gift will be provided. Dr. Gardiner will begin the science café by giving an overview of chronic pain in the US. The moderator will ask the participants questions about how chronic pain impacts their communities and how technology might help address it.
A trained qualitative research assistant will be transcribe the science cafe and the transcripts will be analyzed using qualitative methods.
Pilot Cohort Study During the first ten months, the investigators will pilot, using pre-post measures, with 40 patients (2 groups of 20 patients) with OWL. The main outcome is pain impact (pain severity, pain interference, physical function) and pain associated outcomes (e.g., depression, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain self-efficacy).
The target population includes low-income adults >18 years old who self-report: chronic musculoskeletal (extremity, joint, back, neck) pain for at least 3 months, with an average pain intensity for the previous week >4 on a 0 to 10 numerical rating scale. The investigators also require English fluency sufficient to follow instructions. Exclusion criteria include: active or planned worker's compensation, active substance abuse, psychosis, disability or personal injury claims, and known pregnancy. Participants who do not currently have access to the internet are also excluded.
The investigators will recruit patients from 14 Boston area Community Health Centers and the community of Boston Medical Center by reaching out to primary care providers for referrals. Based upon previous pilot experiences, the investigators do not anticipate any difficulty in recruiting for the pilot groups. The investigators will recruit from BMC's primary care practices and several of its 14 affiliated Community Health Centers located in Boston. Participants will receive $50 for their involvement. Based upon this initial referral, if an individual appears to be eligible for participation, he/she will be invited to meet in person with the research assistant. At this visit, eligibility is verified; the study is discussed at length with all questions answered to the participant's satisfaction; and if the patient desires, the patient enrolls by signing the informed consent. For the study, all recruitment materials will be IRB-approved prior to dissemination.
At the beginning of the study, the investigators will hold a group orientation for all 20 participants in the class on how to navigate OWL. A clinician (assisted by a RA) will demonstrate how to use the OWL system, log on, navigate through the nine sessions, complete self-assessment, set goals, and interact on the community page. Participants will have access to OWL for 9 weeks. Each week they will have access to a new content. The clinician will monitor and post questions to facilitate conversation on the community page. At the end of the 9 weeks participants will be invited back to participate in a focus group and complete 9 week follow up surveys.
- Conditions
- Chronic Pain
- Being tested
- Our Whole Lives Website
- Keywords
- Chronic Pain, mhealth, Integrative Medicine, MBSR, Mindfulness Based Stress Reduction, Web based, Internet Based
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Our Whole Lives WebsiteBehavioural
OWL is a nine-session, web accessible, self-paced curriculum that has interactive components of self-monitoring and social support (online community).
| Study group | Role | What they receive |
|---|---|---|
| Science Cafe | No intervention | One time event, Group discussion for 30 participants who are chronic pain stakeholders on pain in their community. |
| Cohort 1- Pilot OWL Study | Experimental | Participants will pilot test a website- Our Whole Lives website for nine weeks in order to determine if it will help with their chronic pain management. Receives: Behavioral: Our Whole Lives Website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Impact
a combined score of questions measuring pain severity, pain interference, and physical function. This outcome will be assessed using the PROMIS 29 scale. This information will be gathered both at baseline and in the nine week follow up survey for the two cohorts of participants pilot testing of the OWL website.
Measured: 9 weeks
Secondary outcomes (5)
Depression
These outcomes will also be assessed using the PROMIS 29 measure for the two cohorts of participants pilot testing the website at both baseline and nine weeks.
Measured: 9 weeks
Anxiety
These outcomes will also be assessed using the PROMIS 29 measure for the two cohorts of participants pilot testing the website at both baseline and nine weeks.
Measured: 9 weeks
Fatigue
These outcomes will also be assessed using the PROMIS 29 measure for the two cohorts of participants pilot testing the website at both baseline and nine weeks.
Measured: 9 weeks
Sleep Disturbance
These outcomes will also be assessed using the PROMIS 29 measure for the two cohorts of participants pilot testing the website at both baseline and nine weeks.
Measured: 9 weeks
Ability to participate in social roles and activities
These outcomes will also be assessed using the PROMIS 29 measure for the two cohorts of participants pilot testing the website at both baseline and nine weeks.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Aetna, Inc.
- Responsible party
- Principal investigator, Paula Gardiner, Boston Medical Center
- Investigators
- Paula Gardiner, MD,MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788539
- Sponsor's protocol ID
- H-35182
- Acronym
- OWL
- Status last verified
- Feb 2018
- First submitted
- 27 May 2016
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dresner D, Gergen Barnett K, Resnick K, Laird LD, Gardiner P. Listening to Their Words: A Qualitative Analysis of Integrative Medicine Group Visits in an Urban Underserved Medical Setting. Pain Med. 2016 Jun;17(6):1183-1191. doi: 10.1093/pm/pnw030. Epub 2016 Apr 3.
PubMed 27040666Gardiner P, Dresner D, Barnett KG, Sadikova E, Saper R. Medical group visits: a feasibility study to manage patients with chronic pain in an underserved urban clinic. Glob Adv Health Med. 2014 Jul;3(4):20-6. doi: 10.7453/gahmj.2014.011.
PubMed 25105072Saper RB, Boah AR, Keosaian J, Cerrada C, Weinberg J, Sherman KJ. Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial. Evid Based Complement Alternat Med. 2013;2013:658030. doi: 10.1155/2013/658030. Epub 2013 Jun 26.
PubMed 23878604Saper RB, Sherman KJ, Delitto A, Herman PM, Stevans J, Paris R, Keosaian JE, Cerrada CJ, Lemaster CM, Faulkner C, Breuer M, Weinberg J. Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial. Trials. 2014 Feb 26;15:67. doi: 10.1186/1745-6215-15-67.
PubMed 24568299
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Disparities in the Treatment of Chronic Pain Using an Innovative mHealth Tool
- ClinicalTrials.gov ID
- NCT02788539
- Acronym / sponsor ID
- OWL / H-35182
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, mhealth, Integrative Medicine, MBSR, Mindfulness Based Stress Reduction, Web based, Internet Based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Aetna, Inc.
- Study start
- Jun 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 2 Jun 2016 (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.
This project will work to increase knowledge about the utility of a website for management of chronic pain, Our Whole Lives (OWL). It will do so by examining barriers and facilitators to patient use. In order to gather this information, the investigators will conduct a Science Cafe with 30 individuals (including participants with chronic pain, who have family members with chronic pain or are a stakeholder in the chronic pain community) to gather feedback about how to tailor the OWL website to their needs and preferences and how to improve ease of use for this tool. The investigators will also pilot two cohorts with 40 patients with chronic pain (2 groups of 20 patients) with OWL, the patient-centered, mobile health chronic pain management resource, measuring pain impact (pain severity, pain interference, physical function) and pain associated outcomes (e.g., depression, anxiety, fatigue, sleep disturbance, ability to participate in social roles and activities, pain self-efficacy, health education impact and internalized stigma related to chronic pain).
Detailed description
During the first 4 months, conduct a science café targeting 30 individuals/families who live with chronic pain and reside in Boston's low-income, ethnically diverse neighborhoods, in order to: a) gather feedback about how to tailor the OWL curriculum based on their needs and preferences, and b) identify potential enhancements to the mobile technology to improve ease of use. For the science cafe, the investigators will use social media (facebook, twitter, listservs, etc.) to invite the community to meet for a two-hour dialog. . Each participant will be paid for attending, refreshments will be served, and a small thank you gift will be provided. Dr. Gardiner will begin the science café by giving an overview of chronic pain in the US. The moderator will ask the participants questions about how chronic pain impacts their communities and how technology might help address it.
A trained qualitative research assistant will be transcribe the science cafe and the transcripts will be analyzed using qualitative methods.
Pilot Cohort Study During the first ten months, the investigators will pilot, using pre-post measures, with 40 patients (2 groups of 20 patients) with OWL. The main outcome is pain impact (pain severity, pain interference, physical function) and pain associated outcomes (e.g., depression, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain self-efficacy).
The target population includes low-income adults >18 years old who self-report: chronic musculoskeletal (extremity, joint, back, neck) pain for at least 3 months, with an average pain intensity for the previous week >4 on a 0 to 10 numerical rating scale. The investigators also require English fluency sufficient to follow instructions. Exclusion criteria include: active or planned worker's compensation, active substance abuse, psychosis, disability or personal injury claims, and known pregnancy. Participants who do not currently have access to the internet are also excluded.
The investigators will recruit patients from 14 Boston area Community Health Centers and the community of Boston Medical Center by reaching out to primary care providers for referrals. Based upon previous pilot experiences, the investigators do not anticipate any difficulty in recruiting for the pilot groups. The investigators will recruit from BMC's primary care practices and several of its 14 affiliated Community Health Centers located in Boston. Participants will receive $50 for their involvement. Based upon this initial referral, if an individual appears to be eligible for participation, he/she will be invited to meet in person with the research assistant. At this visit, eligibility is verified; the study is discussed at length with all questions answered to the participant's satisfaction; and if the patient desires, the patient enrolls by signing the informed consent. For the study, all recruitment materials will be IRB-approved prior to dissemination.
At the beginning of the study, the investigators will hold a group orientation for all 20 participants in the class on how to navigate OWL. A clinician (assisted by a RA) will demonstrate how to use the OWL system, log on, navigate through the nine sessions, complete self-assessment, set goals, and interact on the community page. Participants will have access to OWL for 9 weeks. Each week they will have access to a new content. The clinician will monitor and post questions to facilitate conversation on the community page. At the end of the 9 weeks participants will be invited back to participate in a focus group and complete 9 week follow up surveys.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Science Cafe | No intervention | –One time event, Group discussion for 30 participants who are chronic pain stakeholders on pain in their community. |
| Cohort 1- Pilot OWL Study | Experimental | Behavioral: Our Whole Lives WebsiteParticipants will pilot test a website- Our Whole Lives website for nine weeks in order to determine if it will help with their chronic pain management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For Pilot Cohort Study- Chronic pain greater than or equal to 4 on a 0-10 scale for a least 12 weeks
- For Pilot Cohort Study- English comprehension sufficient to provide informed consent and understand website information.
Key exclusion criteria (4 listed)
- For Pilot Cohort Study: Pregnant or planning to become pregnant in the next 3 months.
- For Pilot Cohort Study- Does not currently have access to the internet
- For Pilot Cohort Study- Begun a new pain treatment in the past month or plans to begin new pain treatments in the next 3 months.
- For Pilot Cohort Study- Does not have an internet enabled device he/she could use to access the website
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 |
|---|---|---|
| Our Whole Lives WebsiteOWL is a nine-session, web accessible, self-paced curriculum that has interactive components of self-monitoring and social support (online community). | Behavioural | Cohort 1- Pilot OWL Study |
Primary outcome
Pain Impact
Time frame: 9 weeks
a combined score of questions measuring pain severity, pain interference, and physical function. This outcome will be assessed using the PROMIS 29 scale. This information will be gathered both at baseline and in the nine week follow up survey for the two cohorts of participants pilot testing of the OWL website.
5 secondary outcomes
Depression
Time frame: 9 weeks
Anxiety
Time frame: 9 weeks
Fatigue
Time frame: 9 weeks
Sleep Disturbance
Time frame: 9 weeks
Ability to participate in social roles and activities
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Background: PubMed 27040666Dresner D, Gergen Barnett K, Resnick K, Laird LD, Gardiner P. Listening to Their Words: A Qualitative Analysis of Integrative Medicine Group Visits in an Urban Underserved Medical Setting. Pain Med. 2016 Jun;17(6):1183-1191. doi: 10.1093/pm/pnw030. Epub 2016 Apr 3.
- Background: PubMed 25105072Gardiner P, Dresner D, Barnett KG, Sadikova E, Saper R. Medical group visits: a feasibility study to manage patients with chronic pain in an underserved urban clinic. Glob Adv Health Med. 2014 Jul;3(4):20-6. doi: 10.7453/gahmj.2014.011.
- Background: PubMed 23878604Saper RB, Boah AR, Keosaian J, Cerrada C, Weinberg J, Sherman KJ. Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial. Evid Based Complement Alternat Med. 2013;2013:658030. doi: 10.1155/2013/658030. Epub 2013 Jun 26.
- Background: PubMed 24568299Saper RB, Sherman KJ, Delitto A, Herman PM, Stevans J, Paris R, Keosaian JE, Cerrada CJ, Lemaster CM, Faulkner C, Breuer M, Weinberg J. Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial. Trials. 2014 Feb 26;15:67. doi: 10.1186/1745-6215-15-67.
- Related InfoLink provided by the sponsor.
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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.
Paula Gardiner, MD,MPH principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Our Whole Lives Website in people with Chronic Pain, run by Boston Medical Center 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 2 inclusion and 4 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 13 Feb 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain Impact (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02788539, which also lists 4 linked publications.
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 13 Feb 2018.