Our Whole Lives: Online Chronic Pain Management

NCT02788539 | Completed

• 1 other identifier: H-35182
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Pain

Keywords

Chronic Pain; mhealth; Integrative Medicine; MBSR; Mindfulness Based Stress Reduction; Web based; Internet Based

Outcome Measures

Primary Outcomes (1)

• 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.

  9 weeks

Secondary Outcomes (5)

• Depression

  9 weeks

• Anxiety

  9 weeks

• Fatigue

  9 weeks

• Sleep Disturbance

  9 weeks

• Ability to participate in social roles and activities

  9 weeks

Other Outcomes (4)

• Pain Self-Efficacy

  9 weeks

• Perceived Stress

  9 weeks

• Internalized Stigma from Chronic Pain

  9 weeks

Study Arms (2)

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.

Behavioral: Our Whole Lives Website

Interventions

Our Whole Lives Website BEHAVIORAL

OWL is a nine-session, web accessible, self-paced curriculum that has interactive components of self-monitoring and social support (online community).

Cohort 1- Pilot OWL Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• Aetna, Inc.: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (4)

• 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.

  PMID: 27040666 BACKGROUND

• 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.

  PMID: 25105072 BACKGROUND

• 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.

  PMID: 23878604 BACKGROUND

• 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.

  PMID: 24568299 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paula Gardiner, MD,MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 2, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 13, 2018

Record last verified: 2018-02

Locations

US (1)