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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Coping skills training (CST) for chronic pain
Usual care
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring OA, Pain, Cognitive Therapy, Behavior Therapy, Knee OA, Hip OA

Eligibility Criteria

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

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

Sites / Locations

  • Stony Brook Primary Care
  • Rheumatology Associates of Long Island
  • Piedmont Primary Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

This group will serve as the control group and will receive only the care usually given to OA patients.

This group will take part in the 10-session treatment program that will teach patients cognitive and behavioral skills to cope with pain.

Outcomes

Primary Outcome Measures

Pain
Physical disability
Psychological disability
Self-efficacy
Use of coping strategies
Quality of life

Secondary Outcome Measures

Cost effectiveness of treatment
RE-AIM measures of treatment fidelity

Full Information

First Posted
March 12, 2008
Last Updated
September 25, 2013
Sponsor
Stony Brook University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00636454
Brief Title
Effectiveness of a Training Program in Improving Coping Skills in People With Arthritis Pain
Official Title
Coping Skills Training for Arthritis: An Effectiveness Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
OA, Pain, Cognitive Therapy, Behavior Therapy, Knee OA, Hip OA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
257 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
This group will serve as the control group and will receive only the care usually given to OA patients.
Arm Title
2
Arm Type
Experimental
Arm Description
This group will take part in the 10-session treatment program that will teach patients cognitive and behavioral skills to cope with pain.
Intervention Type
Behavioral
Intervention Name(s)
Coping skills training (CST) for chronic pain
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Participants will receive the care usually given to patients with knee or hip OA.
Primary Outcome Measure Information:
Title
Pain
Time Frame
Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups
Title
Physical disability
Time Frame
Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups
Title
Psychological disability
Time Frame
Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups
Title
Self-efficacy
Time Frame
Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups
Title
Use of coping strategies
Time Frame
Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups
Title
Quality of life
Time Frame
Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups
Secondary Outcome Measure Information:
Title
Cost effectiveness of treatment
Time Frame
Measured at 12-month follow-up
Title
RE-AIM measures of treatment fidelity
Time Frame
Throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan E. Broderick, PhD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook Primary Care
City
Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Rheumatology Associates of Long Island
City
Smithtown and Port Jefferson
State/Province
New York
Country
United States
Facility Name
Piedmont Primary Care
City
Danville
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

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

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