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Internet-Based Osteoarthritis Pain Coping Skills Intervention (PainCOACH)

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PainCOACH
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

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

Inclusion Criteria:

  • A formal clinical diagnosis of OA affecting one or both knees or hips
  • Significant OA pain
  • Must be aged 18 or older
  • Must be English speaking

Exclusion Criteria:

  • Not fluent in English
  • Have less than 7th grade English reading proficiency
  • Show signs of cognitive impairment that would prevent comprehension of consent procedures or study measures and procedures
  • Have a medical condition that would contraindicate safe participation in the study (as determined by study physician)

Sites / Locations

  • Duke University
  • UNC-CH Thurston Arthritis Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Study arm will complete the 8-week Internet-based pain coping skills program.

This study arm will only provide demographic and pain-related information.

Outcomes

Primary Outcome Measures

Change in pain intensity
The Arthritis Impact Measurement Scale-2 (AIMS-2) pain subscale that measures severity of arthritis pain, frequency of severe pain, duration of morning stiffness, frequency of joint pain, and difficulty sleeping due to pain

Secondary Outcome Measures

Change in pain-related anxiety
Pain Anxiety Symptoms Scale, 20 item version (PASS-20), which assesses fear of pain, cognitive anxiety, escape-avoidance behaviors, and physiological symptoms of anxiety
Change in pain-related interference with functioning
Arthritis Impact Measurement Scale-2 (AIMS-2) functioning subscales, summed across mobility, walking/bending, self- care, household tasks, social activities, work activities
Change in bodily relaxation
From a behavioral observation task; assessed with brief self-report measure of perceived relaxation and electromyograph (EMG) monitor using external electrodes measuring frontalis muscle tension and indicated by change in frontalis muscle tension during the relaxation task and muscle tension achieved at end of task
Change in problem solving skills
From a behavioral observation task; quality and quantity of responses to hypothetical situation describing a pain flare and asking participants how they would manage it, along with subjective success assessed with an adapted version of the Arthritis Self-Efficacy scale (ASE)
Change in emotional adjustment
Positive and Negative Affect Schedule-20 item version (PANAS)
Program Usability
To help assess tolerability of the intervention site; for intervention arm participants only; qualitative (open-ended) questions to gather feedback on PainCOACH program (usability, usefulness, influence on attitudes/motivation, likes/dislikes)
Number of participants recruited
To assess feasibility
Number of participants who complete the study
To assess tolerability
Number of participants who adhere to study protocol
To assess tolerability
Medication type and frequency of use during the past week
To help assess types of medication used for arthritis pain
Change in and use of pain coping strategies
Adapted Coping Strategies Questionnaire (CSQ), Chronic Pain Coping Inventory (CPCI) subscales, West Haven-Yale Multidimensional Pain Inventory (WHYMPI) subscales, and additional items that measure use of strategies taught
Personality
Ten-Item Personality Inventory (TIPI)
Change in self-efficacy for pain management
Arthritis Self-Efficacy scale (ASE)
Change in social support
Adapted West Haven-Yale Multidimensional Pain Inventory (WHYMPI) subscale

Full Information

First Posted
June 21, 2012
Last Updated
November 14, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT01638871
Brief Title
Internet-Based Osteoarthritis Pain Coping Skills Intervention
Acronym
PainCOACH
Official Title
Internet-Based Osteoarthritis Pain Coping Skills Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to translate a proven pain coping skills intervention for osteoarthritis (OA) patients into an engaging and easy-to-use Internet-based intervention that uses innovative technologies to mimic traditional, in-person training sessions.
Detailed Description
Twenty-one million Americans live with osteoarthritis (OA), a progressive joint disease that causes stiffness, pain, reduced range of motion, distress, and decrements in physical, social, and role functioning. Medical treatments for OA pain are limited and present risks, especially for older populations. However, cognitive behavioral pain coping skills interventions have proven effective for decreasing OA pain, disability, and distress. Unfortunately, existing programs reach a limited number of patients because they require patients to travel to receive in-person training. There is a need for interventions that address the needs of a larger proportion of the rapidly growing population of people whose functioning and quality of life are severely diminished by OA. Delivering proven pain management interventions via the Internet is a promising way to address this need, especially in light of increasing use of the Internet by older Americans. To be most effective, an Internet-based intervention would need to mimic key features of in-person interventions. The proposed intervention will do that by translating a proven in-person pain coping skills protocol into an interactive Internet-based application that uses multimedia and expert systems technology to mimic in-person interventions. It will provide individualized feedback, interactive problem solving, and animated demonstrations, and it will incorporate learning techniques from Bandura's Social Cognitive Theory, including modeling, mastery experiences, and social reinforcement. The project includes two phases, corresponding to two specific aims. In Phase I the investigators will translate the in-person intervention for delivery on the Internet. This phase will including gathering feedback from patient and expert therapist focus groups, which will help refine the program. In Phase II the investigators will conduct a small-scale randomized controlled trial that will enable us to examine and refine features designed to increase motivation and adherence over the course of the 8-week Internet-based intervention. The trial will also enable the investigators to demonstrate its feasibility, tolerability, safety, and promise. The investigators hypothesize that the trial will demonstrate the effectiveness of the Internet for delivery of this OA pain coping skills intervention. Taken together, these activities will prepare the program for testing in a full-scale randomized controlled trial in the next stage of this research. The promise of this project is enhanced by the multi-disciplinary research team, which has expertise in the conduct of cognitive behavioral interventions that teach OA patients to use coping skills to manage their pain, developing and implementing individualized computerized feedback reports using expert systems technology, and development of engaging, user-friendly, interactive computer-based programs for learning and assessment. Relevance: This Internet-based OA pain coping skills intervention targets a significant individual and public health problem and expands access to an empirically-supported pain self-management program so that it can reach a greater proportion of the large and growing population of people suffering from OA pain and related disability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Study arm will complete the 8-week Internet-based pain coping skills program.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This study arm will only provide demographic and pain-related information.
Intervention Type
Behavioral
Intervention Name(s)
PainCOACH
Intervention Description
The 8-week Internet-based pain coping skills intervention program includes 8 sessions. Each session takes 30-45 minutes to complete and includes text, illustrations, photos, animations, audio narration, interactivity, and delivery of personalized feedback. Users will be expected to complete 1 session per week.
Primary Outcome Measure Information:
Title
Change in pain intensity
Description
The Arthritis Impact Measurement Scale-2 (AIMS-2) pain subscale that measures severity of arthritis pain, frequency of severe pain, duration of morning stiffness, frequency of joint pain, and difficulty sleeping due to pain
Time Frame
Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Secondary Outcome Measure Information:
Title
Change in pain-related anxiety
Description
Pain Anxiety Symptoms Scale, 20 item version (PASS-20), which assesses fear of pain, cognitive anxiety, escape-avoidance behaviors, and physiological symptoms of anxiety
Time Frame
Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Title
Change in pain-related interference with functioning
Description
Arthritis Impact Measurement Scale-2 (AIMS-2) functioning subscales, summed across mobility, walking/bending, self- care, household tasks, social activities, work activities
Time Frame
Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Title
Change in bodily relaxation
Description
From a behavioral observation task; assessed with brief self-report measure of perceived relaxation and electromyograph (EMG) monitor using external electrodes measuring frontalis muscle tension and indicated by change in frontalis muscle tension during the relaxation task and muscle tension achieved at end of task
Time Frame
Baseline to post-intervention (at approximately 10 weeks)
Title
Change in problem solving skills
Description
From a behavioral observation task; quality and quantity of responses to hypothetical situation describing a pain flare and asking participants how they would manage it, along with subjective success assessed with an adapted version of the Arthritis Self-Efficacy scale (ASE)
Time Frame
Baseline to post-intervention (at approximately 10 weeks)
Title
Change in emotional adjustment
Description
Positive and Negative Affect Schedule-20 item version (PANAS)
Time Frame
Baseline to post-intervention (at approximately 10 weeks)
Title
Program Usability
Description
To help assess tolerability of the intervention site; for intervention arm participants only; qualitative (open-ended) questions to gather feedback on PainCOACH program (usability, usefulness, influence on attitudes/motivation, likes/dislikes)
Time Frame
Post-intervention (at approximately 10 weeks)
Title
Number of participants recruited
Description
To assess feasibility
Time Frame
up to 10 weeks
Title
Number of participants who complete the study
Description
To assess tolerability
Time Frame
through 10 weeks and/or 6 months
Title
Number of participants who adhere to study protocol
Description
To assess tolerability
Time Frame
through 10 weeks and/or 6 months
Title
Medication type and frequency of use during the past week
Description
To help assess types of medication used for arthritis pain
Time Frame
Baseline, mid-point, and post-intervention
Title
Change in and use of pain coping strategies
Description
Adapted Coping Strategies Questionnaire (CSQ), Chronic Pain Coping Inventory (CPCI) subscales, West Haven-Yale Multidimensional Pain Inventory (WHYMPI) subscales, and additional items that measure use of strategies taught
Time Frame
Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Title
Personality
Description
Ten-Item Personality Inventory (TIPI)
Time Frame
Baseline
Title
Change in self-efficacy for pain management
Description
Arthritis Self-Efficacy scale (ASE)
Time Frame
Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Title
Change in social support
Description
Adapted West Haven-Yale Multidimensional Pain Inventory (WHYMPI) subscale
Time Frame
Baseline to post-intervention (at approximately 10 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A formal clinical diagnosis of OA affecting one or both knees or hips Significant OA pain Must be aged 18 or older Must be English speaking Exclusion Criteria: Not fluent in English Have less than 7th grade English reading proficiency Show signs of cognitive impairment that would prevent comprehension of consent procedures or study measures and procedures Have a medical condition that would contraindicate safe participation in the study (as determined by study physician)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Rini, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Facility Name
UNC-CH Thurston Arthritis Research Center
City
Smithfield
State/Province
North Carolina
ZIP/Postal Code
27577
Country
United States

12. IPD Sharing Statement

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Internet-Based Osteoarthritis Pain Coping Skills Intervention

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