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OsteoarthritisPhase 2/3NCT00636454

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

A Phase 2/3 study testing Coping skills training (CST) for chronic pain in people with Osteoarthritis, run by Stony Brook University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
Coping skills training (CST) for chronic pain
Could I receive a placebo?
No, everyone receives an active treatment
How many people
257 participants
Where
3 sitesUnited States
Study dates
May 2008to Jun 2013
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Scheduled for joint replacement surgery within the 18 months following study entry

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Piedmont Primary Care

    Danville, Virginia

  • Stony Brook Primary Care

    Setauket, New York, 11733

  • Rheumatology Associates of Long Island

    Smithtown and Port Jefferson, New York

Other trials in United States

About this study

Official title: Coping Skills Training for Arthritis: An Effectiveness Trial

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.

Read the 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.

Conditions
Osteoarthritis
Being tested
Coping skills training (CST) for chronic pain, Usual care
Keywords
OA, Pain, Cognitive Therapy, Behavior Therapy, Knee OA, Hip OA
Medical subject headings
Osteoarthritis, Pain, Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coping skills training (CST) for chronic painBehavioural

    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.

  • Usual careOther

    Participants will receive the care usually given to patients with knee or hip OA.

Study groups in NCT00636454
Study groupRoleWhat they receive
1Active comparatorThis group will serve as the control group and will receive only the care usually given to OA patients.
Receives: Other: Usual care
2ExperimentalThis group will take part in the 10-session treatment program that will teach patients cognitive and behavioral skills to cope with pain.
Receives: Behavioral: Coping skills training (CST) for chronic pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain

    Measured: Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups

  2. Physical disability

    Measured: Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups

  3. Psychological disability

    Measured: Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups

  4. Self-efficacy

    Measured: Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups

  5. Use of coping strategies

    Measured: Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups

  6. Quality of life

    Measured: Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups

Secondary outcomes (2)
  1. Cost effectiveness of treatment

    Measured: Measured at 12-month follow-up

  2. RE-AIM measures of treatment fidelity

    Measured: Throughout the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00636454
Sponsor's protocol ID
R01AR054626
Other IDs
R01AR054626, 1R01AR054626-01A1, 3R01AR054626-03S2
Status last verified
Sep 2013
First submitted
12 Mar 2008
Last updated
27 Sep 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Coping skills training (CST) for chronic pain in people with Osteoarthritis, run by Stony Brook University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain (time frame: Measured pre-treatment, post-treatment, and at 6-month and 1-year follow-ups). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2013.

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