Internet-Based Osteoarthritis Pain Coping Skills Intervention

NCT ID: NCT01638871

Last Updated: 2017-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-02-28

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

PainCOACH

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PainCOACH

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 Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Rini, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Duke University

Durham, North Carolina, United States

UNC-CH Thurston Arthritis Research Center

Smithfield, North Carolina, United States

Countries

United States

Other Identifiers

5R01AR057346-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10-1384

Identifier Type: -

Identifier Source: org_study_id