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Our Whole Lives: Online Chronic Pain Management (OWL)

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Our Whole Lives Website
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Pain focused on measuring Chronic Pain, mhealth, Integrative Medicine, MBSR, Mindfulness Based Stress Reduction, Web based, Internet Based

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Science Cafe

Cohort 1- Pilot OWL Study

Arm Description

One time event, Group discussion for 30 participants who are chronic pain stakeholders on pain in their community.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
May 27, 2016
Last Updated
February 9, 2018
Sponsor
Boston Medical Center
Collaborators
Aetna, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02788539
Brief Title
Our Whole Lives: Online Chronic Pain Management
Acronym
OWL
Official Title
Reducing Disparities in the Treatment of Chronic Pain Using an Innovative mHealth Tool
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
Aetna, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic Pain, mhealth, Integrative Medicine, MBSR, Mindfulness Based Stress Reduction, Web based, Internet Based

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Science Cafe
Arm Type
No Intervention
Arm Description
One time event, Group discussion for 30 participants who are chronic pain stakeholders on pain in their community.
Arm Title
Cohort 1- Pilot OWL Study
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Our Whole Lives Website
Intervention Description
OWL is a nine-session, web accessible, self-paced curriculum that has interactive components of self-monitoring and social support (online community).
Primary Outcome Measure Information:
Title
Pain Impact
Description
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
Secondary Outcome Measure Information:
Title
Depression
Description
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
Title
Anxiety
Description
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
Title
Fatigue
Description
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
Title
Sleep Disturbance
Description
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
Title
Ability to participate in social roles and activities
Description
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
Other Pre-specified Outcome Measures:
Title
Pain Self-Efficacy
Description
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
Title
Perceived Stress
Description
Perception of Stress
Time Frame
9 weeks
Title
Internalized Stigma from Chronic Pain
Description
Perception of stigma from chronic pain
Time Frame
9 weeks
Title
Health Education Impact
Description
instrument for the comprehensive evaluation of patient education programs, which can be applied across a broad range of chronic conditions
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Gardiner, MD,MPH
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27040666
Citation
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.
Results Reference
background
PubMed Identifier
25105072
Citation
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.
Results Reference
background
PubMed Identifier
23878604
Citation
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.
Results Reference
background
PubMed Identifier
24568299
Citation
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.
Results Reference
background
Links:
URL
https://www.ourwholelives.org/
Description
Related Info

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Our Whole Lives: Online Chronic Pain Management

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