Effectiveness of a Training Program in Improving Coping Skills in People With Arthritis Pain

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joan Broderick, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00636454
First received: March 12, 2008
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

Osteoarthritis (OA) is the leading cause of disability in the United States. Studies have shown that training patients to cope with pain improves physical and social functioning, increases self-efficacy, and reduces psychological distress. However, this type of training is not available to the vast majority of OA patients. This study will determine the effectiveness of a training program for coping with pain that will be administered in community medical practices.

A THIRD ARM OF THE TRIAL WAS FUNDED 09/09. TREATED PATIENTS WILL BE RANDOMIZED TO (1)A 4-MONTH COMPUTER-DRIVEN TELEPHONE PROGRAM TO ENHANCE MAINTANENCE OF TREATMENT GAINS OR (2)USUAL CARE. THIS ARM WILL ONLY BE CONDUCTED AT THE STONY BROOK SITE.


Condition Intervention Phase
Osteoarthritis
Behavioral: Coping skills training (CST) for chronic pain
Other: Usual care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Coping Skills Training for Arthritis: An Effectiveness Trial

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Pain [ Time Frame: Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups ] [ Designated as safety issue: No ]
  • Physical disability [ Time Frame: Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups ] [ Designated as safety issue: No ]
  • Psychological disability [ Time Frame: Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups ] [ Designated as safety issue: No ]
  • Self-efficacy [ Time Frame: Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups ] [ Designated as safety issue: No ]
  • Use of coping strategies [ Time Frame: Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost effectiveness of treatment [ Time Frame: Measured at 12-month follow-up ] [ Designated as safety issue: No ]
  • RE-AIM measures of treatment fidelity [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment: 257
Study Start Date: May 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
This group will serve as the control group and will receive only the care usually given to OA patients.
Other: Usual care
Participants will receive the care usually given to patients with knee or hip OA.
Experimental: 2
This group will take part in the 10-session treatment program that will teach patients cognitive and behavioral skills to cope with pain.
Behavioral: Coping skills training (CST) for chronic pain
Participants will attend 10 sessions lasting between 45 and 60 minutes each. Topics will include relaxation training, managing activity cycles, and changing thought patterns to reduce the negative effects of pain.

Detailed Description:

OA affects approximately 60 percent of people older than 65 and can cause significant pain and impairment in functioning. Biomedical treatments are limited in their ability to curb OA disease progression and to eliminate pain and functional impairment. Consequently, health-related quality of life is often significantly impaired in people with arthritis. In academic research settings, pain coping skills training (CST) for arthritis improves the negative physical and social effects of OA. However, CST is not available to the vast majority of OA patients. Proving that CST is equally successful in community medical settings might make it more available to patients receiving care in these settings. Nurses with training in patient education are likely to be well-suited to deliver CST. This study will determine the effectiveness of CST for reducing arthritis pain when it is administered by nurse practitioners and registered nurses in community medical settings.

Participants in this study will be randomly assigned to either take part in a 10-session CST program for chronic pain or receive usual care. Participants in the treatment program will attend sessions in their doctor's offices. A nurse practitioner or registered nurse will meet with each participant for approximately 45 minutes each week to teach methods for management of pain associated with OA. Some of the strategies will include relaxation training, managing activity cycles, and changing thought patterns to reduce the negative effects of pain. Some sessions may be conducted on the phone rather than in person. All sessions will be tape-recorded for quality assurance purposes. Participants will be asked to practice coping skills between visits. At the end of the last visit, participants will spend an additional 60 minutes completing a booklet of questions about their health, pain levels, and response to the treatment program. Participants assigned to the usual care group will continue to see their healthcare providers as they normally would. They will not meet with the nurse or receive the CST. Assessments of pain, physical and psychological disability, self-efficacy, pain coping skills, and quality of life will be conducted for all participants pre-treatment, post-treatment, and at 6-month and 1-year follow-ups.

THE THIRD ARM OF THE TRIAL WILL PROVIDE 4 MONTHS OF PRE-RECORDED REVIEW OF COPING SKILLS TRAINING AS WELL AS DAILY RATINGS OF ARTHRITIS-RELATED PATIENT REPORTED OUTCOMES VIA A COMPUTER-DRIVEN TELEPHONE PROGRAM. PATIENTS ARE ASKED TO COMPLETE THE DAILY RATINGS AND CAN OPT TO LISTEN TO REVIEWS AND PRACTICE SESSIONS OF THE SKILLS THEY LEARNED WHILE RECEIVING CST TREATMENT FROM THE NURSE. AT THE END OF EACH MONTH, THE NURSE REVIEWS THE DAILY RATINGS AND PATIENT UTILIZATION OF THE REVIEW PROGRAM AND RECORDS A PERSONALIZED MESSAGE TO THE PATIENT TO IDENTIFY IMPORTANT PATTERNS AND TO ENCOURAGE USE OF THE PROGRAM.

TWO SETS OF PATIENTS WILL BE RANDOMIZED INTO THIS THIRD ARM OF THE TRIAL: THOSE WHO COMPLETED THE 12-MONTH STUDY ASSESSMENT ("OLD PATIENTS") AND THOSE WHO ARE JUST ENTERING THE TRIAL ("NEW PATIENTS"). THE FORMER WILL DETERMINE IF THE TELEPHONE MAINTANENCE PROGRAM IS EFFECTIVE FOR PATIENTS WHO COMPLETED CST TREATMENT OVER A YEAR AGO; THE LATTER WILL DETERMINE IF IT IS EFFECTIVE FOR PATIENTS WHEN USED IMMEDIATELY AT THE END OF CST TREATMENT. A TOTAL OF 50 PATIENTS WILL PARTICIPATE IN THE THIRD ARM OF THE TRIAL. OUTCOMES WILL BE MEASURED PRIOR TO THE START OF THE TELPHONE MAINTANENCE PROGRAM AND AT THE END OF THE 4-MONTH PROGRAM. OUTCOME ASSESSMENTS WILL BE IDENTICAL TO THOSE IN THE MAIN TRIAL.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient in one of the two recruitment community clinics
  • Diagnosis of knee or hip OA
  • History of pain greater than or equal to a 4 on a 10-point scale for at least 6 months prior to study entry
  • Able to read, write, and understand English
  • Absence of significant psychiatric or cognitive dysfunction
  • Able to attend 10 treatment sessions
  • Access to telephone to complete interactive voice response (IVR) ratings and possible phone sessions
  • Completion of baseline assessment

Exclusion Criteria:

  • Scheduled for joint replacement surgery within the 18 months following study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636454

Locations
United States, New York
Stony Brook Primary Care
Setauket, New York, United States, 11733
Rheumatology Associates of Long Island
Smithtown and Port Jefferson, New York, United States
United States, Virginia
Piedmont Primary Care
Danville, Virginia, United States
Sponsors and Collaborators
Stony Brook University
Investigators
Principal Investigator: Joan E. Broderick, PhD Stony Brook University
  More Information

No publications provided

Responsible Party: Joan Broderick, Principal Investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00636454     History of Changes
Other Study ID Numbers: R01 AR054626, R01AR054626, 1R01AR054626-01A1, 3R01AR054626-03S2
Study First Received: March 12, 2008
Last Updated: September 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Stony Brook University:
OA
Pain
Cognitive Therapy
Behavior Therapy
Knee OA
Hip OA

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 23, 2014