Clinical trial NCT01638871: Internet-Based Osteoarthritis Pain Coping Skills Intervention
Official title: Internet-Based Osteoarthritis Pain Coping Skills Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2012-07-12
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in pain intensity
timeFrame: Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Secondary outcomes:
measure: Change in pain-related anxiety
timeFrame: Baseline to post-intervention (at approximately 10 weeks and at 6 months)
measure: Change in pain-related interference with functioning
timeFrame: Baseline to post-intervention (at approximately 10 weeks and at 6 months)
measure: Change in bodily relaxation
timeFrame: Baseline to post-intervention (at approximately 10 weeks)
measure: Change in problem solving skills
timeFrame: Baseline to post-intervention (at approximately 10 weeks)
measure: Change in emotional adjustment
timeFrame: Baseline to post-intervention (at approximately 10 weeks)
measure: Program Usability
timeFrame: Post-intervention (at approximately 10 weeks)
measure: Number of participants recruited
timeFrame: up to 10 weeks
measure: Number of participants who complete the study
timeFrame: through 10 weeks and/or 6 months
measure: Number of participants who adhere to study protocol
timeFrame: through 10 weeks and/or 6 months
measure: Medication type and frequency of use during the past week
timeFrame: Baseline, mid-point, and post-intervention
measure: Change in and use of pain coping strategies
timeFrame: Baseline to post-intervention (at approximately 10 weeks and at 6 months)
measure: Personality
timeFrame: Baseline
measure: Change in self-efficacy for pain management
timeFrame: Baseline to post-intervention (at approximately 10 weeks and at 6 months)
measure: Change in social support
timeFrame: Baseline to post-intervention (at approximately 10 weeks)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Smithfield
country: United States
facility: UNC-CH Thurston Arthritis Research Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Christine Rini, PhD
role: PRINCIPAL_INVESTIGATOR
References: