Ignite Creation Date:
2024-05-05 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00636454
Status:
COMPLETED
Last Update Posted:
2013-09-27
First Post:
2008-03-12
Brief Title:
Effectiveness of a Training Program in Improving Coping Skills in People With Arthritis Pain
Sponsor:
Stony Brook University
Organization:
Stony Brook University
Study Overview
Official Title:
Coping Skills Training for Arthritis An Effectiveness Trial
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 0909 TREATED PATIENTS WILL BE RANDOMIZED TO 1A 4-MONTH COMPUTER-DRIVEN TELEPHONE PROGRAM TO ENHANCE MAINTANENCE OF TREATMENT GAINS OR 2USUAL CARE THIS ARM WILL ONLY BE CONDUCTED AT THE STONY BROOK SITE
A THIRD ARM OF THE TRIAL WAS FUNDED 0909 TREATED PATIENTS WILL BE RANDOMIZED TO 1A 4-MONTH COMPUTER-DRIVEN TELEPHONE PROGRAM TO ENHANCE MAINTANENCE OF TREATMENT GAINS OR 2USUAL 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 doctors 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
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 doctors 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3R01AR054626-03S2 | NIH | None | httpsreporternihgovquickSearch3R01AR054626-03S2 |
| R01AR054626 | NIH | None | None |
| 1R01AR054626-01A1 | NIH | None | None |