OsteoarthritisNCT04357262
Resiliency in Total Joint Arthroplasty
A study testing StreaMD in people with Osteoarthritis, run by University of Utah at 1 site in United States.
Trial summary
The investigators primary objective is to determine how does participation in StreaMD affect patient reported outcomes after Total Hip Arthroplasty (THA) or Total Knee Arthroplasty (TKA)? Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- StreaMD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2020to 12 Jan 2022
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients aged 18 and older who are receiving a total hip or knee replacement.
Who cannot join
- Patients enrolled in the MyMobility study
- Patients who do not have cell phones with text messaging capability
- Non-English speaking patients
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
The investigators primary objective is to determine how does participation in StreaMD affect patient reported outcomes after Total Hip Arthroplasty (THA) or Total Knee Arthroplasty (TKA)?
Read the detailed description
Osteoarthritis is a leading cause of disability in the US. By conservative estimates, about 54 million adults in the US have doctor-diagnosed arthritis. The number of people expected to have arthritis by the year 2040 is more than 78 million. Total joint arthroplasty is considered the treatment of choice for end-stage osteoarthritis. Currently, more than 1 million hip and knee replacements are performed each year in the US. By 2030, primary THR is projected to grow 171% and primary TKR is projected to grow by up to 189%, for a projected 635,000 and 1.28 million procedures, respectively. The incidence of pre-operative psychological distress in this group of patients is reported between 30% and 60% and preoperative psychological distress is associated with poorer pain and functional outcomes after surgery. Resilience, characterized by an ability to bounce back or recover from stress, is increasingly recognized as a psychometric property affecting many outcomes' domains including outcomes after TJA. Better resilience could improve patients overall satisfaction with the procedure.
- Conditions
- Osteoarthritis
- Being tested
- StreaMD
- Keywords
- Total Hip Arthroplasty, Total Knee Arthroplasty, Patient Reported Outcomes, Resilience
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StreaMDOther
Patients who are randomized to the intervention arm will be signed up for the automated text messaging program. Patients will receive automated text messages related to their surgery during the study period and can also ask questions through the text messages program, where automated messages will be sent based on the questions asked.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No other non-standard of care activities will be performed |
| Intervention | Experimental | Will be signed up for the automated text messaging program (StreaMD) Receives: Other: StreaMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcome Score (PROMIS) following THA or TKA
Patient reported outcome will consist of the Patient-Reported Outcomes Measurement Information System (PROMIS)
Measured: Follow Up Visits up to 2-Years
Patient Reported Outcome Score (HOOS Jr.) following THA or TKA
Patient reported outcome will consist of the hip disability and osteoarthritis outcome score (HOOS Jr.)
Measured: Follow Up Visits up to 2-Years
Patient Reported Outcome Score (KOOS Jr.) following THA or TKA
Patient reported outcome will consist of the knee injury and osteoarthritis outcome score (KOOS Jr.)
Measured: Follow Up Visits up to 2-Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start5 Mar 2020
- Primary completion12 Jan 2022
- Study completion12 Jan 2022
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.
- More trials run by University of UtahThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Gililland, University of Utah
- Investigators
- Jeremy Gililland, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357262
- Sponsor's protocol ID
- 129070
- Status last verified
- Jul 2022
- First submitted
- 15 Apr 2020
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resiliency in Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT04357262
- Acronym / sponsor ID
- 129070
- Conditions
- Osteoarthritis
- Keywords
- Total Hip Arthroplasty, Total Knee Arthroplasty, Patient Reported Outcomes, Resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 22 Apr 2020 (actual)
- 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 investigators primary objective is to determine how does participation in StreaMD affect patient reported outcomes after Total Hip Arthroplasty (THA) or Total Knee Arthroplasty (TKA)?
Detailed description
Osteoarthritis is a leading cause of disability in the US. By conservative estimates, about 54 million adults in the US have doctor-diagnosed arthritis. The number of people expected to have arthritis by the year 2040 is more than 78 million. Total joint arthroplasty is considered the treatment of choice for end-stage osteoarthritis. Currently, more than 1 million hip and knee replacements are performed each year in the US. By 2030, primary THR is projected to grow 171% and primary TKR is projected to grow by up to 189%, for a projected 635,000 and 1.28 million procedures, respectively. The incidence of pre-operative psychological distress in this group of patients is reported between 30% and 60% and preoperative psychological distress is associated with poorer pain and functional outcomes after surgery. Resilience, characterized by an ability to bounce back or recover from stress, is increasingly recognized as a psychometric property affecting many outcomes' domains including outcomes after TJA. Better resilience could improve patients overall satisfaction with the procedure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No other non-standard of care activities will be performed |
| Intervention | Experimental | Other: StreaMDWill be signed up for the automated text messaging program (StreaMD) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients aged 18 and older who are receiving a total hip or knee replacement.
Key exclusion criteria (3 listed)
- Patients enrolled in the MyMobility study
- Patients who do not have cell phones with text messaging capability
- Non-English speaking patients
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 |
|---|---|---|
| StreaMDPatients who are randomized to the intervention arm will be signed up for the automated text messaging program. Patients will receive automated text messages related to their surgery during the study period and can also ask questions through the text messages program, where automated messages will be sent based on the questions asked. | Other | Intervention |
Primary outcome
Patient Reported Outcome Score (PROMIS) following THA or TKA
Time frame: Follow Up Visits up to 2-Years
Patient reported outcome will consist of the Patient-Reported Outcomes Measurement Information System (PROMIS)
Patient Reported Outcome Score (HOOS Jr.) following THA or TKA
Time frame: Follow Up Visits up to 2-Years
Patient reported outcome will consist of the hip disability and osteoarthritis outcome score (HOOS Jr.)
Patient Reported Outcome Score (KOOS Jr.) following THA or TKA
Time frame: Follow Up Visits up to 2-Years
Patient reported outcome will consist of the knee injury and osteoarthritis outcome score (KOOS Jr.)
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 15 Jul 2022.
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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.
Jeremy Gililland, M.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StreaMD in people with Osteoarthritis, run by University of Utah 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 1 inclusion and 3 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 15 Jul 2022. 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?
Patient Reported Outcome Score (PROMIS) following THA or TKA (time frame: Follow Up Visits up to 2-Years). The study lists 3 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 15 Jul 2022.