Internet-Based Osteoarthritis Pain Coping Skills Intervention

NCT01638871 | Completed

• 2 other identifiers: 10-13845R01AR057346-02
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline to post-intervention (at approximately 10 weeks and at 6 months)

Secondary Outcomes (14)

• Change in pain-related anxiety

  Baseline to post-intervention (at approximately 10 weeks and at 6 months)

• Change in pain-related interference with functioning

  Baseline to post-intervention (at approximately 10 weeks and at 6 months)

• Change in bodily relaxation

  Baseline to post-intervention (at approximately 10 weeks)

• Change in problem solving skills

  Baseline to post-intervention (at approximately 10 weeks)

• Change in emotional adjustment

  Baseline to post-intervention (at approximately 10 weeks)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: PainCOACH

Control Group

NO INTERVENTION

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

Interventions

PainCOACH BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (2)

Duke University

Durham, North Carolina, 27708, United States

Location

UNC-CH Thurston Arthritis Research Center

Smithfield, North Carolina, 27577, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Christine Rini, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: July 12, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 17, 2017

Record last verified: 2014-02

Locations

US (2)