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Community-Engaged Options to Facilitate Opioid Reduction (COMFORT)

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-pharmacological pain treatment
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring chronic pain, opioid, complementary

Eligibility Criteria

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

Inclusion Criteria:

  • enrollment in treatment at the CHAS Perry St or partnering clinic;
  • age greater than 18 years;
  • ability to read, speak, and write English;
  • diagnosed with a chronic, non-cancer-based painful medical condition;
  • ability to provide informed consent.

Exclusion Criteria:

  • pregnancy;
  • diagnosis of a cancer-based painful medical condition;
  • any other medical or psychiatric condition that the PI or Co-PI physician of record determine might compromise safe study participation (including but not limited to active psychosis, history of frequent psychiatric hospitalizations, severe anxiety with claustrophobia, aggression)

Sites / Locations

  • Community Health Association of SpokaneRecruiting
  • Washington State University College of NursingRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm pain treatment

Arm Description

Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks

Outcomes

Primary Outcome Measures

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity rating
3 items asking about pain severity (range 3 to 15 with higher score worse pain intensity)
PROMIS Pain interference rating
8 items asking about pain interference with life (range 8 to 40 with higher score worse pain interference)

Secondary Outcome Measures

Depressive symptoms using Patient Health Questionnaire (PHQ-8)
Patient Health Questionnaire (PHQ-8) 8-item scale with score range 0-24 (higher score is worsened depressive symptoms)
PROMIS Self-efficacy for managing symptoms short form 4a
Self-efficacy self-report (range 4-20 with higher score better symptom management self-efficacy)
PROMIS Self-efficacy for managing emotions short form 4a
Self-efficacy self-report (range 4-20 with higher score better emotion management self-efficacy)
Anxiety using Generalized Anxiety Disorder (GAD-7)
7-item scale with score range 0-21 (higher score is worsened anxiety)
Interpersonal Needs Questionnaire
9-item scale asking how one feels about others score range 0-18 (lower score indicates more unmet interpersonal needs)
Current Opioid Misuse Measure
17-item scale to ask about use of opioids (range 0-64 with higher scores indicating more misuse)
Spiritual Well-being Index
4-items to ask about spiritual well-being (range 4-20 with higher scores indicating more spiritual well-being)

Full Information

First Posted
July 13, 2020
Last Updated
October 15, 2021
Sponsor
Washington State University
Collaborators
Spokane Regional Health District, University of Washington Institute for Translational Health Science (KL2), Rayce Rudeen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05098158
Brief Title
Community-Engaged Options to Facilitate Opioid Reduction
Acronym
COMFORT
Official Title
Community-Engaged Options to Maximize and Facilitate Opioid Reduction Through Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2020 (Actual)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington State University
Collaborators
Spokane Regional Health District, University of Washington Institute for Translational Health Science (KL2), Rayce Rudeen Foundation

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 study investigates how adults prescribed opioids for chronic noncancer pain respond to invitations to try non-opioid options of massage therapy, yoga therapy, chiropractic and physical therapies. Due to the COVID-19 pandemic, these options will be available via telehealth consultation visits using a computer or smartphone with internet connection. The investigators will measure effects on pain, pain-related symptoms, and opioid use over time using a single-group design.
Detailed Description
Participants will be recruited from local primary care practices and asked to complete a baseline survey. They will then meet with a registered nurse via teleconference for a complete pain assessment. At the end of the session, participants will be asked to choose two of four available modalities for telehealth consultation. Participants will be scheduled for six telehealth sessions, once per week x six weeks with three consultations per each chosen therapy. Measurements of pain, mood, sleep, medicine use will be captured at baseline, three weeks and six weeks and examined for changes over time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, opioid, complementary

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group studied over 6 weeks time
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm pain treatment
Arm Type
Experimental
Arm Description
Arm includes usual pain care plus the chosen two telehealth interventions x 6 weeks
Intervention Type
Other
Intervention Name(s)
Non-pharmacological pain treatment
Intervention Description
Participant selects from telehealth consultation on massage therapy, yoga therapy, chiropractic and physical therapies.
Primary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity rating
Description
3 items asking about pain severity (range 3 to 15 with higher score worse pain intensity)
Time Frame
6 weeks
Title
PROMIS Pain interference rating
Description
8 items asking about pain interference with life (range 8 to 40 with higher score worse pain interference)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Depressive symptoms using Patient Health Questionnaire (PHQ-8)
Description
Patient Health Questionnaire (PHQ-8) 8-item scale with score range 0-24 (higher score is worsened depressive symptoms)
Time Frame
6 weeks
Title
PROMIS Self-efficacy for managing symptoms short form 4a
Description
Self-efficacy self-report (range 4-20 with higher score better symptom management self-efficacy)
Time Frame
6 weeks
Title
PROMIS Self-efficacy for managing emotions short form 4a
Description
Self-efficacy self-report (range 4-20 with higher score better emotion management self-efficacy)
Time Frame
6 weeks
Title
Anxiety using Generalized Anxiety Disorder (GAD-7)
Description
7-item scale with score range 0-21 (higher score is worsened anxiety)
Time Frame
6 weeks
Title
Interpersonal Needs Questionnaire
Description
9-item scale asking how one feels about others score range 0-18 (lower score indicates more unmet interpersonal needs)
Time Frame
6 weeks
Title
Current Opioid Misuse Measure
Description
17-item scale to ask about use of opioids (range 0-64 with higher scores indicating more misuse)
Time Frame
6 weeks
Title
Spiritual Well-being Index
Description
4-items to ask about spiritual well-being (range 4-20 with higher scores indicating more spiritual well-being)
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Attendance in scheduled telehealth sessions
Description
Percentage of attendance for each participant in their scheduled telehealth sessions (e.g. 3/6 sessions = 50%)
Time Frame
6 weeks
Title
Satisfaction with intervention
Description
3-item program satisfaction survey to gauge participant satisfaction with the interventions using 1-7 Likert scale (score range 3 to 21 where higher score indicates higher satisfaction)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: enrollment in treatment at the CHAS Perry St or partnering clinic; age greater than 18 years; ability to read, speak, and write English; diagnosed with a chronic, non-cancer-based painful medical condition; ability to provide informed consent. Exclusion Criteria: pregnancy; diagnosis of a cancer-based painful medical condition; any other medical or psychiatric condition that the PI or Co-PI physician of record determine might compromise safe study participation (including but not limited to active psychosis, history of frequent psychiatric hospitalizations, severe anxiety with claustrophobia, aggression)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marian Wilson, PhD
Phone
5093247443
Email
marian.wilson@wsu.edu
Facility Information:
Facility Name
Community Health Association of Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tori Dezellem
Phone
509-444-8888
Email
tdezellem@chas.org
First Name & Middle Initial & Last Name & Degree
Kaleena Reynolds
Phone
509-444-8888
Email
kreynolds@chas.org
Facility Name
Washington State University College of Nursing
City
Spokane
State/Province
Washington
ZIP/Postal Code
99201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marian Wilson, PhD
Phone
509-324-7443
Email
marian.wilson@wsu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Community-Engaged Options to Facilitate Opioid Reduction

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