OsteoarthritisPainCOACHNCT01638871
Internet-Based Osteoarthritis Pain Coping Skills Intervention
A study testing PainCOACH in people with Osteoarthritis, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- PainCOACH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to Feb 2014
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University
Durham, North Carolina, 27708
UNC-CH Thurston Arthritis Research Center
Smithfield, North Carolina, 27577
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- PainCOACH
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PainCOACHBehavioural
The 8-week Internet-based pain coping skills intervention program includes 8 sessions. Each session takes 30-45 minutes to complete and includes text, illustrations, photos, animations, audio narration, interactivity, and delivery of personalized feedback. Users will be expected to complete 1 session per week.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Study arm will complete the 8-week Internet-based pain coping skills program. Receives: Behavioral: PainCOACH |
| Control Group | No intervention | This study arm will only provide demographic and pain-related information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity
The Arthritis Impact Measurement Scale-2 (AIMS-2) pain subscale that measures severity of arthritis pain, frequency of severe pain, duration of morning stiffness, frequency of joint pain, and difficulty sleeping due to pain
Measured: Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Secondary outcomes (14)
Change in pain-related anxiety
Pain Anxiety Symptoms Scale, 20 item version (PASS-20), which assesses fear of pain, cognitive anxiety, escape-avoidance behaviors, and physiological symptoms of anxiety
Measured: Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Change in pain-related interference with functioning
Arthritis Impact Measurement Scale-2 (AIMS-2) functioning subscales, summed across mobility, walking/bending, self- care, household tasks, social activities, work activities
Measured: Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Change in bodily relaxation
From a behavioral observation task; assessed with brief self-report measure of perceived relaxation and electromyograph (EMG) monitor using external electrodes measuring frontalis muscle tension and indicated by change in frontalis muscle tension during the relaxation task and muscle tension achieved at end of task
Measured: Baseline to post-intervention (at approximately 10 weeks)
Change in problem solving skills
From a behavioral observation task; quality and quantity of responses to hypothetical situation describing a pain flare and asking participants how they would manage it, along with subjective success assessed with an adapted version of the Arthritis Self-Efficacy scale (ASE)
Measured: Baseline to post-intervention (at approximately 10 weeks)
Change in emotional adjustment
Positive and Negative Affect Schedule-20 item version (PANAS)
Measured: Baseline to post-intervention (at approximately 10 weeks)
Program Usability
To help assess tolerability of the intervention site; for intervention arm participants only; qualitative (open-ended) questions to gather feedback on PainCOACH program (usability, usefulness, influence on attitudes/motivation, likes/dislikes)
Measured: Post-intervention (at approximately 10 weeks)
Number of participants recruited
To assess feasibility
Measured: up to 10 weeks
Number of participants who complete the study
To assess tolerability
Measured: through 10 weeks and/or 6 months
Number of participants who adhere to study protocol
To assess tolerability
Measured: through 10 weeks and/or 6 months
Medication type and frequency of use during the past week
To help assess types of medication used for arthritis pain
Measured: Baseline, mid-point, and post-intervention
Change in and use of pain coping strategies
Adapted Coping Strategies Questionnaire (CSQ), Chronic Pain Coping Inventory (CPCI) subscales, West Haven-Yale Multidimensional Pain Inventory (WHYMPI) subscales, and additional items that measure use of strategies taught
Measured: Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Personality
Ten-Item Personality Inventory (TIPI)
Measured: Baseline
Change in self-efficacy for pain management
Arthritis Self-Efficacy scale (ASE)
Measured: Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Change in social support
Adapted West Haven-Yale Multidimensional Pain Inventory (WHYMPI) subscale
Measured: Baseline to post-intervention (at approximately 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Christine Rini, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638871
- Sponsor's protocol ID
- 10-1384
- Other IDs
- 5R01AR057346-02
- Acronym
- PainCOACH
- Status last verified
- Feb 2014
- First submitted
- 21 Jun 2012
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Osteoarthritis Pain Coping Skills Intervention
- ClinicalTrials.gov ID
- NCT01638871
- Acronym / sponsor ID
- PainCOACH / 10-1384
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Oct 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: PainCOACHStudy arm will complete the 8-week Internet-based pain coping skills program. |
| Control Group | No intervention | –This study arm will only provide demographic and pain-related information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PainCOACHThe 8-week Internet-based pain coping skills intervention program includes 8 sessions. Each session takes 30-45 minutes to complete and includes text, illustrations, photos, animations, audio narration, interactivity, and delivery of personalized feedback. Users will be expected to complete 1 session per week. | Behavioural | Intervention Group |
Primary outcome
Change in pain intensity
Time frame: Baseline to post-intervention (at approximately 10 weeks and at 6 months)
The Arthritis Impact Measurement Scale-2 (AIMS-2) pain subscale that measures severity of arthritis pain, frequency of severe pain, duration of morning stiffness, frequency of joint pain, and difficulty sleeping due to pain
14 secondary outcomes
Change in pain-related anxiety
Time frame: Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Change in pain-related interference with functioning
Time frame: Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Change in bodily relaxation
Time frame: Baseline to post-intervention (at approximately 10 weeks)
Change in problem solving skills
Time frame: Baseline to post-intervention (at approximately 10 weeks)
Change in emotional adjustment
Time frame: Baseline to post-intervention (at approximately 10 weeks)
Program Usability
Time frame: Post-intervention (at approximately 10 weeks)
Number of participants recruited
Time frame: up to 10 weeks
Number of participants who complete the study
Time frame: through 10 weeks and/or 6 months
Number of participants who adhere to study protocol
Time frame: through 10 weeks and/or 6 months
Medication type and frequency of use during the past week
Time frame: Baseline, mid-point, and post-intervention
Change in and use of pain coping strategies
Time frame: Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Personality
Time frame: Baseline
Change in self-efficacy for pain management
Time frame: Baseline to post-intervention (at approximately 10 weeks and at 6 months)
Change in social support
Time frame: Baseline to post-intervention (at approximately 10 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Rini, PhD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PainCOACH in people with Osteoarthritis, run by University of North Carolina, Chapel Hill at 2 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 4 inclusion and 4 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Change in pain intensity (time frame: Baseline to post-intervention (at approximately 10 weeks and at 6 months)). 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 17 Nov 2017.