Boston Medical Center
Boston, Massachusetts, 02118, United States
NCT Number: NCT02788539
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02118, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
OWL is a nine-session, web accessible, self-paced curriculum that has interactive components of self-monitoring and social support (online community).
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.
Time frame: 9 weeks
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.
Time frame: 9 weeks
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.
Time frame: 9 weeks
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.
Time frame: 9 weeks
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.
Time frame: 9 weeks
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.
Time frame: 9 weeks
Self-efficacy refers to capacity to persevere in the face of obstacles and adverse experiences, in this instance in the face of pain.
Time frame: 9 weeks
Perception of Stress
Time frame: 9 weeks
Perception of stigma from chronic pain
Time frame: 9 weeks
instrument for the comprehensive evaluation of patient education programs, which can be applied across a broad range of chronic conditions
Boston Medical Center
Other
Reducing Disparities in the Treatment of Chronic Pain Using an Innovative mHealth Tool
Acronym: OWL
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