- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02788539
Our Whole Lives: Online Chronic Pain Management (OWL)
Reducing Disparities in the Treatment of Chronic Pain Using an Innovative mHealth Tool
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Science Cafe
One time event, Group discussion for 30 participants who are chronic pain stakeholders on pain in their community.
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Experimental: Cohort 1- Pilot OWL Study
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.
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OWL is a nine-session, web accessible, self-paced curriculum that has interactive components of self-monitoring and social support (online community).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Impact
Time Frame: 9 weeks
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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.
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9 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: 9 weeks
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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.
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9 weeks
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Anxiety
Time Frame: 9 weeks
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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.
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9 weeks
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Fatigue
Time Frame: 9 weeks
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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.
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9 weeks
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Sleep Disturbance
Time Frame: 9 weeks
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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.
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9 weeks
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Ability to participate in social roles and activities
Time Frame: 9 weeks
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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.
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9 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Self-Efficacy
Time Frame: 9 weeks
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Self-efficacy refers to capacity to persevere in the face of obstacles and adverse experiences, in this instance in the face of pain.
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9 weeks
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Perceived Stress
Time Frame: 9 weeks
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Perception of Stress
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9 weeks
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Internalized Stigma from Chronic Pain
Time Frame: 9 weeks
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Perception of stigma from chronic pain
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9 weeks
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Health Education Impact
Time Frame: 9 weeks
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instrument for the comprehensive evaluation of patient education programs, which can be applied across a broad range of chronic conditions
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9 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paula Gardiner, MD,MPH, Boston Medical Center
Publications and helpful links
General 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.
- Gardiner 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.
- Saper 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.
- Saper 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-35182
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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