OsteoarthritisPRIMO-LatinoNCT01782417
Pilot Testing a Patient and Provider Intervention for Managing Osteoarthritis in Hispanic Adults.
A study testing patient and provider intervention in people with Osteoarthritis, run by Duke University at 1 site in United States.
Trial summary
Hispanics are affected by arthritis at a slightly lower age-adjusted rate compared to non-Hispanic whites and African Americans. However, compared to other groups, Hispanics have a higher prevalence of arthritis-attributed activity limitations (primarily related to OA), are less likely to receive hip replacement… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- patient and provider intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jun 2015
- 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
- Radiographic evidence of hip OA and/or radiographic evidence of or meets clinical criteria for knee OA
- Current joint (hip and/or knee) symptoms
- BMI >= 25
- Physically inactive
- Spanish speakers
Who cannot join
- Diagnosis of rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease
- Diagnosis of a motor neuron disease, Parkinson's disease, multiple sclerosis, or Paget's disease
- Diagnosis of metastatic cancer
- Hospitalized for a stroke, myocardial infarction or coronary artery revascularization in the past 3 months
- On waiting list for or planning arthroplasty
- Total joint replacement (hip or knee) surgery, other hip or knee surgery, meniscus tear (verified by MRI), or (anterior cruciate ligament) ACL tear in the past 6 months
Show all 19Show fewer
- History of gout in hip or knee
- Quadriplegia or paraplegia
- Active diagnosis of psychosis or serious personality disorder
- Diagnosis of dementia or other memory loss condition
- Current, uncontrolled substance abuse disorder
- Severly impaired speech or hearing (patients must be able to respond to phone calls)
- No access to a telephone
- Resident in nursing home
- Serious / terminal illness as indicated by referral to hospice or palliative care
- For females: currently pregnant or planning to become pregnant
- Participating in another OA intervention of other lifestyle change study
- Other self-reported medical problem that would prohibit participation in the study
- Other health condition or personal issue judged by a study team member or primary care physician to make the patient inappropriate for study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Hispanics are affected by arthritis at a slightly lower age-adjusted rate compared to non-Hispanic whites and African Americans. However, compared to other groups, Hispanics have a higher prevalence of arthritis-attributed activity limitations (primarily related to OA), are less likely to receive hip replacement independent of health care access, and are less likely to receive knee replacement. The study is conducted to develop and test a telephone delivered intervention for the management of OA in Hispanic adults. This study is conducted as a minority supplement to the Patient and Provider Interventions for Managing Osteoarthritis in Primary Care (PRIMO) NCT01435109 and Pro00022836.
Read the detailed description
Arthritis affects approximately 50 million adults in the United States (US), making it one of the most common causes of disability in this county. In addition, is associated with significant physical activity limitations, increased prevalence of obesity, decreased health related quality of life, and increased health care costs. Hispanics are affected by arthritis at a slightly lower age-adjusted rate compared to non-Hispanic whites and African Americans. However, compared to other groups, Hispanics have a higher prevalence of arthritis-attributed activity limitations (primarily related to OA), are less likely to receive hip replacement independent of health care access, and are less likely to receive knee replacement. In addition, there have been very few interventions to improve either medical or behavioral aspects of OA treatment recommendations among the Hispanic population. The study will developed and test a culturally appropriate Spanish educational materials and telephone scripts for the patient- and provider-based interventions and will test the patient and provider intervention in a group of Adult Hispanics with OA.
- Conditions
- Osteoarthritis
- Being tested
- patient and provider intervention
- Keywords
- osteoarthritis, Hispanic, behavior, intervention, Spanish
- Medical subject headings
- Osteoarthritis, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient and provider interventionBehavioural
Patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management; primary care providers receive patient-specific osteoarthritis information and treatment recommendations at the point of clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Patient and provider intervention | Other | participants will receive a patient and provider intervention Receives: Behavioral: patient and provider intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-reported pain, stiffness and function.
Measured by the validated Spanish version of the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC).
Measured: baseline, 6 months and 12 months.
Secondary outcomes (4)
Change in Physical function
Short Physical Performance Test Protocol
Measured: Baseline and 12 months
Change in Depressive symptoms
Measured with the Spanish version of the Patient Health Questionnaire (PHQ-8).
Measured: Baseline and 12 months
Change in weight
measured on a standard scale
Measured: Baseline and 12 months
Participants perception of the intervention
Semi structured interviews
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelli Allen, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782417
- Sponsor's protocol ID
- Pro00022836_1
- Acronym
- PRIMO-Latino
- Status last verified
- Jun 2015
- First submitted
- 31 Jan 2013
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Corsino L, Coffman CJ, Stanwyck C, Oddone EZ, Bosworth HB, Chatterjee R, Jeffreys AS, Dolor RJ, Allen KD. A feasibility study to develop and test a Spanish patient and provider intervention for managing osteoarthritis in Hispanic/Latino adults (PRIMO-Latino). Pilot Feasibility Stud. 2018 Jul 4;4:89. doi: 10.1186/s40814-018-0280-x. eCollection 2018.
PubMed 29997898
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing a Patient and Provider Intervention for Managing Osteoarthritis in Hispanic Adults.
- ClinicalTrials.gov ID
- NCT01782417
- Acronym / sponsor ID
- PRIMO-Latino / Pro00022836_1
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, Hispanic, behavior, intervention, Spanish
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Feb 2013 (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.
Hispanics are affected by arthritis at a slightly lower age-adjusted rate compared to non-Hispanic whites and African Americans. However, compared to other groups, Hispanics have a higher prevalence of arthritis-attributed activity limitations (primarily related to OA), are less likely to receive hip replacement independent of health care access, and are less likely to receive knee replacement. The study is conducted to develop and test a telephone delivered intervention for the management of OA in Hispanic adults. This study is conducted as a minority supplement to the Patient and Provider Interventions for Managing Osteoarthritis in Primary Care (PRIMO) NCT01435109 and Pro00022836.
Detailed description
Arthritis affects approximately 50 million adults in the United States (US), making it one of the most common causes of disability in this county. In addition, is associated with significant physical activity limitations, increased prevalence of obesity, decreased health related quality of life, and increased health care costs. Hispanics are affected by arthritis at a slightly lower age-adjusted rate compared to non-Hispanic whites and African Americans. However, compared to other groups, Hispanics have a higher prevalence of arthritis-attributed activity limitations (primarily related to OA), are less likely to receive hip replacement independent of health care access, and are less likely to receive knee replacement. In addition, there have been very few interventions to improve either medical or behavioral aspects of OA treatment recommendations among the Hispanic population. The study will developed and test a culturally appropriate Spanish educational materials and telephone scripts for the patient- and provider-based interventions and will test the patient and provider intervention in a group of Adult Hispanics with OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient and provider intervention | Other | Behavioral: patient and provider interventionparticipants will receive a patient and provider intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Radiographic evidence of hip OA and/or radiographic evidence of or meets clinical criteria for knee OA
- Current joint (hip and/or knee) symptoms
- BMI >= 25
- Physically inactive
- Spanish speakers
Key exclusion criteria (19 listed)
- Diagnosis of rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease
- Diagnosis of a motor neuron disease, Parkinson's disease, multiple sclerosis, or Paget's disease
- Diagnosis of metastatic cancer
- Hospitalized for a stroke, myocardial infarction or coronary artery revascularization in the past 3 months
- On waiting list for or planning arthroplasty
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 |
|---|---|---|
| patient and provider interventionPatients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management; primary care providers receive patient-specific osteoarthritis information and treatment recommendations at the point of clinical care. | Behavioural | Patient and provider intervention |
Primary outcome
Change in Self-reported pain, stiffness and function.
Time frame: baseline, 6 months and 12 months.
Measured by the validated Spanish version of the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC).
4 secondary outcomes
Change in Physical function
Time frame: Baseline and 12 months
Change in Depressive symptoms
Time frame: Baseline and 12 months
Change in weight
Time frame: Baseline and 12 months
Participants perception of the intervention
Time frame: 12 months
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 14 Oct 2015.
- Derived from this study: PubMed 29997898Corsino L, Coffman CJ, Stanwyck C, Oddone EZ, Bosworth HB, Chatterjee R, Jeffreys AS, Dolor RJ, Allen KD. A feasibility study to develop and test a Spanish patient and provider intervention for managing osteoarthritis in Hispanic/Latino adults (PRIMO-Latino). Pilot Feasibility Stud. 2018 Jul 4;4:89. doi: 10.1186/s40814-018-0280-x. eCollection 2018.
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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 Allen, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient and provider intervention in people with Osteoarthritis, run by Duke University 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 5 inclusion and 19 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 14 Oct 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?
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 Self-reported pain, stiffness and function. (time frame: baseline, 6 months and 12 months.). 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 NCT01782417, which also lists 1 linked publication.
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 14 Oct 2015.