OsteoarthritisSeMOANCT00288912
Self-Management of Osteoarthritis
A study testing Health Education and Osteoarthritis Self-Management in people with Osteoarthritis, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to examine whether a telephone-based self-management intervention improves pain, physical function, and other outcomes among veterans with osteoarthritis of the hip or knee. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Health Education and Osteoarthritis Self-Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 523 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Sep 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Radiographic evidence of hip or knee osteoarthritis
- Current / persistent joint symptoms (pain, aching, stiffness)
Who cannot join
- Other rheumatic disease (i.e., rheumatoid arthritis, fibromyalgia)
- Hospitalization for stroke or cardiovascular event within past 3 months
- Metastatic cancer
- Active diagnosis of psychosis
- Terminal illness
- On waiting list for arthroplasty
Show all 11Show fewer
- Resident of nursing home
- Severely impaired in hearing or speech (participants must be able to respond to phone calls)
- Significant cognitive dysfunction
- No access to a telephone
- Current participation in another interventional study for osteoarthritis
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
About this study
Official title: Self-Management of Osteoarthritis: A Tailored, Telephone-based Intervention
The purpose of this study is to examine whether a telephone-based self-management intervention improves pain, physical function, and other outcomes among veterans with osteoarthritis of the hip or knee.
Read the detailed description
Background / Rationale: Osteoarthritis (OA) is the one of the most common chronic conditions among veterans, and over half of VA health care users with OA report being limited in their daily activities because of joint symptoms. However, studies have not examined interventions to improve outcomes or quality of care among the large and growing number of veterans with OA. Telephone-based self-management interventions may be a cost-effective way to improve pain, physical function, and other outcomes in this patient population. Objective: The purpose of this study is to examine the effectiveness of a one-year telephone-based self-management intervention for veterans with hip or knee OA. The primary hypothesis is that the self-management intervention will result in a greater reduction in pain as compared to both usual care and attention control conditions. Methods: This will be a randomized control trial of 519 veterans at the Durham VAMC who have radiographic evidence and a physician diagnosis of OA of the hip or knee. Participants will be equally allocated to self-management, attention control, and usual care groups. The self-management intervention is designed to provide participants with key information about OA and its treatment and to enhance participants' self-efficacy for managing OA-related symptoms. This intervention will involve provision of written, audio, and video educational materials, as well as monthly telephone calls by a nurse. The nurse will guide participants in developing personal OA-related goals, as well as specific plans for meeting these goals. Other strategies for enhancing self-efficacy will include modeling and mastery of self-management behaviors, persuasion to adopt these behaviors, and reinterpretation of OA symptoms. The attention control group will receive written materials on health screening related topics (not OA-related), and the nurse will call participants on a monthly basis to discuss these materials. The primary outcome measure for this study will be self-reported pain (Arthritis Impact Measurement-2 (AIMS2) subscale), and secondary outcomes will be self-reported function (AIMS2 subscale), affect (AIMS2 subscale), and arthritis specific self-efficacy. Outcomes will be measured at baseline and following the one-year study period. Analysis of covariance will be used to compare primary and secondary outcomes between the intervention group and each of the control groups, adjusting for baseline measures, participant demographic and clinical characteristics. We will also examine the cost-effectiveness of the intervention. Impact: This study is significant because it examines a highly prevalent but understudied chronic illness among veterans. In addition, this OA self-management program will contribute to the VA health care system's specific mission to improve pain management through patient education and participation. The proposed self-management intervention will be low-cost and easy to disseminate within the VA health care system. Therefore it may be an important tool for improving outcomes, especially pain, among many veterans with OA.
- Conditions
- Osteoarthritis
- Being tested
- Health Education, Osteoarthritis Self-Management
- Keywords
- Self-Care, Telemedicine, Pain, Veterans
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationBehavioural
12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.
Osteoarthritis Self-ManagementBehavioural
12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| Health Education Intervention | Active comparator | Health Education Intervention Receives: Behavioral: Health Education |
| Usual Medical Care | No intervention | Usual Medical Care |
| Osteoarthritis Self-Management | Experimental | Osteoarthritis Self-Management Receives: Behavioral: Osteoarthritis Self-Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Arthritis Impact Measurement Scales-2 (AIMS2), which consists of five items assessing typical pain, pain severity, and pain during specific times of the day, using a 5-point Likert scale ("all days" to "no days"). The possible range of scores is 0-10, with higher scores indicating more severe pain.
Measured: Baseline and 12-month follow-up
Secondary outcomes (3)
AIMS 2 Physical Function
The AIMS2 physical function subscale includes 28 items that measure aspects of mobility, walking and bending, hand and finger function, arm function, self-care, and household tasks. All items on the AIMS2 physical function subscale are measured on a 5-point Likert scale ("all days" to "no days"). Scores can range from 0-10, with higher scores indicating worse function.
Measured: Baseline and 12-month follow-up
AIMS 2 Affect
The AIMS2 affect subscale includes ten items that encompass mood and tension. All items on the AIMS2 affect subscale are measured on a 5-point Likert scale ("all days" to "no days"). Scores can range from 0-10, with higher scores indicating worse affect.
Measured: Baseline and 12 months
Arthritis Self Efficacy
The Arthritis Self-Efficacy Scale measures how certain patients are they can perform 8 specific activities or tasks, related to arthritis. Items are scored on a Likert Scale (1=very uncertain to 10=very certain), with total scores ranging from 1-10. Higher scores indicate greater arthritis self-efficacy.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startOct 2006
- Primary completionJul 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 523 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kelli Dominick Allen, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288912
- Sponsor's protocol ID
- IIR 04-016
- Acronym
- SeMOA
- Status last verified
- Apr 2015
- First submitted
- 6 Feb 2006
- Last updated
- 24 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sperber NR, Allen KD, Devellis BM, Devellis RF, Lewis MA, Callahan LF. Differences in effectiveness of the active living every day program for older adults with arthritis. J Aging Phys Act. 2013 Oct;21(4):387-401. doi: 10.1123/japa.21.4.387. Epub 2012 Nov 19.
PubMed 23170757Sperber NR, Bosworth HB, Coffman CJ, Juntilla KA, Lindquist JH, Oddone EZ, Walker TA, Weinberger M, Allen KD. Participant evaluation of a telephone-based osteoarthritis self-management program, 2006-2009. Prev Chronic Dis. 2012;9:E73. Epub 2012 Mar 22.
PubMed 22440547Sperber NR, Bosworth HB, Coffman CJ, Lindquist JH, Oddone EZ, Weinberger M, Allen KD. Differences in osteoarthritis self-management support intervention outcomes according to race and health literacy. Health Educ Res. 2013 Jun;28(3):502-11. doi: 10.1093/her/cyt043. Epub 2013 Mar 22.
PubMed 23525779Allen KD, Oddone EZ, Stock JL, Coffman CJ, Lindquist JH, Juntilla KA, Lemmerman DS, Datta SK, Harrelson ML, Weinberger M, Bosworth HB. The Self-Management of OsteoArthritis in Veterans (SeMOA) Study: design and methodology. Contemp Clin Trials. 2008 Jul;29(4):596-607. doi: 10.1016/j.cct.2007.11.004. Epub 2007 Nov 22.
PubMed 18206425Allen KD, Oddone EZ, Coffman CJ, Keefe FJ, Lindquist JH, Bosworth HB. Racial differences in osteoarthritis pain and function: potential explanatory factors. Osteoarthritis Cartilage. 2010 Feb;18(2):160-7. doi: 10.1016/j.joca.2009.09.010. Epub 2009 Oct 1.
PubMed 19825498Allen KD, Oddone EZ, Coffman CJ, Datta SK, Juntilla KA, Lindquist JH, Walker TA, Weinberger M, Bosworth HB. Telephone-based self-management of osteoarthritis: A randomized trial. Ann Intern Med. 2010 Nov 2;153(9):570-9. doi: 10.7326/0003-4819-153-9-201011020-00006.
PubMed 21041576
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management of Osteoarthritis: A Tailored, Telephone-based Intervention
- ClinicalTrials.gov ID
- NCT00288912
- Acronym / sponsor ID
- SeMOA / IIR 04-016
- Conditions
- Osteoarthritis
- Keywords
- Self-Care, Telemedicine, Pain, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 523 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 8 Feb 2006 (estimated)
- Results
- Posted 12 Sep 2014
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 examine whether a telephone-based self-management intervention improves pain, physical function, and other outcomes among veterans with osteoarthritis of the hip or knee.
Detailed description
Background / Rationale: Osteoarthritis (OA) is the one of the most common chronic conditions among veterans, and over half of VA health care users with OA report being limited in their daily activities because of joint symptoms. However, studies have not examined interventions to improve outcomes or quality of care among the large and growing number of veterans with OA. Telephone-based self-management interventions may be a cost-effective way to improve pain, physical function, and other outcomes in this patient population. Objective: The purpose of this study is to examine the effectiveness of a one-year telephone-based self-management intervention for veterans with hip or knee OA. The primary hypothesis is that the self-management intervention will result in a greater reduction in pain as compared to both usual care and attention control conditions. Methods: This will be a randomized control trial of 519 veterans at the Durham VAMC who have radiographic evidence and a physician diagnosis of OA of the hip or knee. Participants will be equally allocated to self-management, attention control, and usual care groups. The self-management intervention is designed to provide participants with key information about OA and its treatment and to enhance participants' self-efficacy for managing OA-related symptoms. This intervention will involve provision of written, audio, and video educational materials, as well as monthly telephone calls by a nurse. The nurse will guide participants in developing personal OA-related goals, as well as specific plans for meeting these goals. Other strategies for enhancing self-efficacy will include modeling and mastery of self-management behaviors, persuasion to adopt these behaviors, and reinterpretation of OA symptoms. The attention control group will receive written materials on health screening related topics (not OA-related), and the nurse will call participants on a monthly basis to discuss these materials. The primary outcome measure for this study will be self-reported pain (Arthritis Impact Measurement-2 (AIMS2) subscale), and secondary outcomes will be self-reported function (AIMS2 subscale), affect (AIMS2 subscale), and arthritis specific self-efficacy. Outcomes will be measured at baseline and following the one-year study period. Analysis of covariance will be used to compare primary and secondary outcomes between the intervention group and each of the control groups, adjusting for baseline measures, participant demographic and clinical characteristics. We will also examine the cost-effectiveness of the intervention. Impact: This study is significant because it examines a highly prevalent but understudied chronic illness among veterans. In addition, this OA self-management program will contribute to the VA health care system's specific mission to improve pain management through patient education and participation. The proposed self-management intervention will be low-cost and easy to disseminate within the VA health care system. Therefore it may be an important tool for improving outcomes, especially pain, among many veterans with OA.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health Education Intervention | Active comparator | Behavioral: Health EducationHealth Education Intervention |
| Usual Medical Care | No intervention | –Usual Medical Care |
| Osteoarthritis Self-Management | Experimental | Behavioral: Osteoarthritis Self-ManagementOsteoarthritis Self-Management |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Radiographic evidence of hip or knee osteoarthritis
- Current / persistent joint symptoms (pain, aching, stiffness)
Key exclusion criteria (11 listed)
- Other rheumatic disease (i.e., rheumatoid arthritis, fibromyalgia)
- Hospitalization for stroke or cardiovascular event within past 3 months
- Metastatic cancer
- Active diagnosis of psychosis
- Terminal illness
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 |
|---|---|---|
| Health Education12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics. | Behavioural | Health Education Intervention |
| Osteoarthritis Self-Management12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis. | Behavioural | Osteoarthritis Self-Management |
Primary outcome
Pain
Time frame: Baseline and 12-month follow-up
Arthritis Impact Measurement Scales-2 (AIMS2), which consists of five items assessing typical pain, pain severity, and pain during specific times of the day, using a 5-point Likert scale ("all days" to "no days"). The possible range of scores is 0-10, with higher scores indicating more severe pain.
3 secondary outcomes
AIMS 2 Physical Function
Time frame: Baseline and 12-month follow-up
AIMS 2 Affect
Time frame: Baseline and 12 months
Arthritis Self Efficacy
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23170757Sperber NR, Allen KD, Devellis BM, Devellis RF, Lewis MA, Callahan LF. Differences in effectiveness of the active living every day program for older adults with arthritis. J Aging Phys Act. 2013 Oct;21(4):387-401. doi: 10.1123/japa.21.4.387. Epub 2012 Nov 19.
- Results publication: PubMed 22440547Sperber NR, Bosworth HB, Coffman CJ, Juntilla KA, Lindquist JH, Oddone EZ, Walker TA, Weinberger M, Allen KD. Participant evaluation of a telephone-based osteoarthritis self-management program, 2006-2009. Prev Chronic Dis. 2012;9:E73. Epub 2012 Mar 22.
- Results publication: PubMed 23525779Sperber NR, Bosworth HB, Coffman CJ, Lindquist JH, Oddone EZ, Weinberger M, Allen KD. Differences in osteoarthritis self-management support intervention outcomes according to race and health literacy. Health Educ Res. 2013 Jun;28(3):502-11. doi: 10.1093/her/cyt043. Epub 2013 Mar 22.
- Results publication: PubMed 18206425Allen KD, Oddone EZ, Stock JL, Coffman CJ, Lindquist JH, Juntilla KA, Lemmerman DS, Datta SK, Harrelson ML, Weinberger M, Bosworth HB. The Self-Management of OsteoArthritis in Veterans (SeMOA) Study: design and methodology. Contemp Clin Trials. 2008 Jul;29(4):596-607. doi: 10.1016/j.cct.2007.11.004. Epub 2007 Nov 22.
- Results publication: PubMed 19825498Allen KD, Oddone EZ, Coffman CJ, Keefe FJ, Lindquist JH, Bosworth HB. Racial differences in osteoarthritis pain and function: potential explanatory factors. Osteoarthritis Cartilage. 2010 Feb;18(2):160-7. doi: 10.1016/j.joca.2009.09.010. Epub 2009 Oct 1.
- Results publication: PubMed 21041576Allen KD, Oddone EZ, Coffman CJ, Datta SK, Juntilla KA, Lindquist JH, Walker TA, Weinberger M, Bosworth HB. Telephone-based self-management of osteoarthritis: A randomized trial. Ann Intern Med. 2010 Nov 2;153(9):570-9. doi: 10.7326/0003-4819-153-9-201011020-00006.
- Durham VA HSR\&D Center of Excellence (Study Site)Link provided by the sponsor.
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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.
Kelli Dominick Allen, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education and Osteoarthritis Self-Management in people with Osteoarthritis, run by US Department of Veterans Affairs at 1 site 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 2 inclusion and 11 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 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 12 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Baseline and 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00288912, which also lists 6 linked publications.
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 24 Apr 2015.