Knee OsteoarthritisPIVOTNCT04615377
The Kaia Hip and Knee Pain Intervention for Self-management of the Pain in Patients With Osteoarthritis.
A study testing Kaia hip and knee pain application and Treatment as usual in people with Knee Osteoarthritis and Hip Osteoarthritis, run by Kaia Health Software at 1 site in United States.
Trial summary
The study intervention provides an innovative way of making exercise training and other recommended lifestyle modifications as accessible as possible for knee and hip OA participants by introducing a home-based exercise training program with a motion track feedback technology. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Knee Osteoarthritis, Hip Osteoarthritis
- What is being tested?
- Kaia hip and knee pain application and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2021to 30 Sep 2021
- 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 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 22 and 75 years old
- Able to speak, read, and understand English
- Able to use an iPad, has internet access at home and a personal email address
- Self-reported diagnosis of OA of knee or hip confirmed by ACR clinical criteria
- Self-reported pain intensity ≥4/10 on Numeric Rating Scale (NRS) for knee and hip pain, on average, in the week prior to screening
- Pain duration ≥1 month
- Willing and capable of providing Informed Consent to use the Kaia Knee and Hip pain app and participate in all assessments associated with this clinical study
Who cannot join
- Referral or plans for surgery, chiropractic care, acupuncture, physical therapy, injections or other treatment for knee or hip pain in the next 3 months following screening
- Self-reported prior subscription to Kaia apps or plans to participate in any other investigational trials or protocols for knee or hip pain
- Prior knee or hip surgery or injury in the last 3 months
- Current workers comp case or litigation related to musculoskeletal pain
- Self-reported use of opioids within 30 days prior to screening
- Self-reported history of substance abuse within the past 1 year
- Self-reported diagnosis of an inflammatory/rheumatologic disease
- Self-reported diagnosis of neuropathic pain disorder or other chronic pain disorder (ex. fibromyalgia, complex regional pain syndrome [CRPS])
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Kaia hiP and Knee paIn Digital Application as an interVention for Self-management of Pain in Patients With OsteoarThritis - a Randomised Controlled Study (Kaia PIVOT Study).
The study intervention provides an innovative way of making exercise training and other recommended lifestyle modifications as accessible as possible for knee and hip OA participants by introducing a home-based exercise training program with a motion track feedback technology. Self-management of the pain for the patients suffering osteoarthritis, in the form of lifestyle modification, implementation of coping strategies and exercise is part of recommendations of recent international guidelines such as those by the Osteoarthritis Research Society International (OARSI). Cost and resource constraints typically limit the access to these recommended therapies. Moreover, the study intervention is focused on maintaining and adapting everyday physical activity, as required, in comparison to the control group.
Read the detailed description
Osteoarthritis (OA) is a painful, degenerative disease of the affected joints. According to surveys by the World Health Organization (WHO) knee and hip joint OA is one of the diseases that make up the largest proportion of all disability diseases.
On the individual patient level, there is a pronounced limitation of the quality of life, which can also lead to the development of secondary diseases. There are numerous methods available for the treatment of OA, the spectrum of which ranges from conservative measures such as physical therapy or medical procedures up to surgical procedures, especially joint replacement. In recent years, the number of prostheses implanted in knee and hip joints has increased significantly.
International guidelines such as those of the American College of Rheumatologists recommend conservative treatment of OA of the knee and hip joint with physical therapy. Multidisciplinary approaches include aerobic and anaerobic exercise training, in particular with the aim of weight loss in overweight participants, participant education for self-management of the disease and the consideration of psychosocial factors. This comprehensive, structured, conservative program for the treatment of OA achieves significantly better results than the standard treatment. However, comparable programs, which offer comprehensive management of OA are not widely available.
Digital therapies represent a novel approach to help patients manage themselves and their diseases in a home setting and even show better results than current standard therapies. An analysis of a smartphone intervention providing a multidisciplinary approach for self-management of lower back pain, the Kaia Back Pain Relief app, shows promising results in 180 users with a significant and clinically relevant reduction of pain levels.
Based on these promising results, this study will evaluate the effectiveness of the Kaia Knee and Hip pain app intervention in comparison to usual medical care in reducing pain and disease-related symptoms in participants with OA over 3 months.
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis
- Being tested
- Kaia hip and knee pain application, Treatment as usual
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaia hip and knee pain applicationBehavioural
The Kaia Knee and Hip pain app software, when loaded onto a smartphone, recommends to the participant specific exercises for the lower extremity. Using the camera on a smartphone, the software then tracks the participant's movements as the participant performs the exercises, analyzes those movements using machine learning, and provides audio-visual feedback to the participant. The exercise therapy is augmented by educational content and cognitive behavioral therapy to provide a multidisciplinary approach to self-management of osteoarthritis. Behavioral Health Coaches ensure participant motivation throughout the program based on a predefined curriculum.
Treatment as usualOther
Participants allocated to the control arm will be advised to continue receiving treatment as usual ( standard care) without restrictions, except participation in other investigational trials, and will likewise be followed up for 90 days. Apart from that, they are encouraged to seek care, as they would do normally.
| Study group | Role | What they receive |
|---|---|---|
| Kaia hip and knee pain app | Experimental | Kaia software application: Kaia Knee and Hip pain app (version 2.37.0) The Kaia Knee and Hip pain app is an investigational device, which is intended as a digital aid for the self-management of osteoarthritis for use by adults (between 22 to 75 years old) without supervision by healthcare professionals in a home setting. Receives: Behavioral: Kaia hip and knee pain application |
| Treatment as usual | Active comparator | Participants will be encouraged to continue the treatment that they have been on without restriction Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index as calculated from Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS).
The primary endpoint is to evaluate the change in the Western Ontario and McMaster Universities Osteoarthritis Index as calculated from Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS).This change will be calculated over day 0 until week 12. Where the higher scores on the HOOS and KOOS indicate worse pain, stiffness, and functional limitations. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
Measured: On day 0, 30, 60 and 90
Secondary outcomes (7)
Pain index as in western Ontario and McMaster's Osteoarthritis Index as derived from Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS).
To evaluate the change from baseline by Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS) and derive the pain score for the Western Ontario and McMaster Universities Osteoarthritis Index pain sub-scale through Week 12 i.e pain score domain (mean of changes in the 5 pain related items) on HOOS or KOOS. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
Measured: On day 0, 30, 60 and 90
Functionality index as in western Ontario and McMaster's Osteoarthritis Index as derived from Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS).
To evaluate the change from baseline by Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS) and derive the Functionality index as for the Western Ontario and McMaster Universities Osteoarthritis functionality sub-scale through Week 12 i.e pain score domain (mean of changes in the 5 pain related items) on HOOS or KOOS. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
Measured: On day 0, 30, 60 and 90
Stiffness score as in western Ontario and McMaster's Osteoarthritis Index as derived from Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS).
To evaluate the change of stiffness from baseline, by Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS), and derive the stiffness index score as for the Western Ontario and McMaster Universities Osteoarthritis stiffness sub-scale, through Week 12 i.e stiffness score domain (mean of changes in the 5 pain related items) on HOOS or KOOS. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
Measured: On day 0, 30, 60 and 90
Patient-Reported Outcomes Measurement Information System (PROMIS Global 10)
Overall change in the Quality of life score assessed by the PROMIS Global 10 questionnaire from baseline to the week 12.
Measured: Information collected on day 0, 30, 60 and 90
Inclination towards healthcare utilization
Self-reported inclination towards healthcare utilization on an 11-point Likert scale. Where (0) means none and (11) means Extreme.
Measured: Information collected only on day 0
Self-reported number of lost workdays
Self-reported number of lost workdays in the month prior to enrolment and during study observational period (assessed at baseline day 0, day 30, day 60, and day 90)
Measured: Information collected only on day 0 and day 90
Pain medication intake
Pain medication intake 30 days prior to enrolment and during study period.
Measured: Information collected on day 0, 30, 60 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start7 Jan 2021
- Primary completion31 Jul 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaia Health Software
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin J Choo, MD, Principal investigator, Orthopaedic and Neurosurgery Specialists, 6 Greenwich Office Park, Greenwich, CT 06831
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615377
- Sponsor's protocol ID
- Kaia US OA Study
- Other IDs
- USOA001
- Acronym
- PIVOT
- Status last verified
- Aug 2022
- First submitted
- 23 Oct 2020
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Kaia hiP and Knee paIn Digital Application as an interVention for Self-management of Pain in Patients With OsteoarThritis - a Randomised Controlled Study (Kaia PIVOT Study).
- ClinicalTrials.gov ID
- NCT04615377
- Acronym / sponsor ID
- PIVOT / Kaia US OA Study
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Kaia Health SoftwareIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 4 Nov 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 study intervention provides an innovative way of making exercise training and other recommended lifestyle modifications as accessible as possible for knee and hip OA participants by introducing a home-based exercise training program with a motion track feedback technology. Self-management of the pain for the patients suffering osteoarthritis, in the form of lifestyle modification, implementation of coping strategies and exercise is part of recommendations of recent international guidelines such as those by the Osteoarthritis Research Society International (OARSI). Cost and resource constraints typically limit the access to these recommended therapies. Moreover, the study intervention is focused on maintaining and adapting everyday physical activity, as required, in comparison to the control group.
Detailed description
Osteoarthritis (OA) is a painful, degenerative disease of the affected joints. According to surveys by the World Health Organization (WHO) knee and hip joint OA is one of the diseases that make up the largest proportion of all disability diseases.
On the individual patient level, there is a pronounced limitation of the quality of life, which can also lead to the development of secondary diseases. There are numerous methods available for the treatment of OA, the spectrum of which ranges from conservative measures such as physical therapy or medical procedures up to surgical procedures, especially joint replacement. In recent years, the number of prostheses implanted in knee and hip joints has increased significantly.
International guidelines such as those of the American College of Rheumatologists recommend conservative treatment of OA of the knee and hip joint with physical therapy. Multidisciplinary approaches include aerobic and anaerobic exercise training, in particular with the aim of weight loss in overweight participants, participant education for self-management of the disease and the consideration of psychosocial factors. This comprehensive, structured, conservative program for the treatment of OA achieves significantly better results than the standard treatment. However, comparable programs, which offer comprehensive management of OA are not widely available.
Digital therapies represent a novel approach to help patients manage themselves and their diseases in a home setting and even show better results than current standard therapies. An analysis of a smartphone intervention providing a multidisciplinary approach for self-management of lower back pain, the Kaia Back Pain Relief app, shows promising results in 180 users with a significant and clinically relevant reduction of pain levels.
Based on these promising results, this study will evaluate the effectiveness of the Kaia Knee and Hip pain app intervention in comparison to usual medical care in reducing pain and disease-related symptoms in participants with OA over 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kaia hip and knee pain app | Experimental | Behavioral: Kaia hip and knee pain applicationKaia software application: Kaia Knee and Hip pain app (version 2.37.0) The Kaia Knee and Hip pain app is an investigational device, which is intended as a digital aid for the self-management of osteoarthritis for use by adults (between 22 to 75 years old) without supervision by healthcare professionals in a home setting. |
| Treatment as usual | Active comparator | Other: Treatment as usualParticipants will be encouraged to continue the treatment that they have been on without restriction |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Between 22 and 75 years old
- Able to speak, read, and understand English
- Able to use an iPad, has internet access at home and a personal email address
- Self-reported diagnosis of OA of knee or hip confirmed by ACR clinical criteria
- Self-reported pain intensity ≥4/10 on Numeric Rating Scale (NRS) for knee and hip pain, on average, in the week prior to screening
Key exclusion criteria (8 listed)
- Referral or plans for surgery, chiropractic care, acupuncture, physical therapy, injections or other treatment for knee or hip pain in the next 3 months following screening
- Self-reported prior subscription to Kaia apps or plans to participate in any other investigational trials or protocols for knee or hip pain
- Prior knee or hip surgery or injury in the last 3 months
- Current workers comp case or litigation related to musculoskeletal pain
- Self-reported use of opioids within 30 days prior to screening
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 |
|---|---|---|
| Kaia hip and knee pain applicationThe Kaia Knee and Hip pain app software, when loaded onto a smartphone, recommends to the participant specific exercises for the lower extremity. Using the camera on a smartphone, the software then tracks the participant's movements as the participant performs the exercises, analyzes those movements using machine learning, and provides audio-visual feedback to the participant. The exercise therapy is augmented by educational content and cognitive behavioral therapy to provide a multidisciplinary approach to self-management of osteoarthritis. Behavioral Health Coaches ensure participant motivation throughout the program based on a predefined curriculum. | Behavioural | Kaia hip and knee pain app |
| Treatment as usualParticipants allocated to the control arm will be advised to continue receiving treatment as usual ( standard care) without restrictions, except participation in other investigational trials, and will likewise be followed up for 90 days. Apart from that, they are encouraged to seek care, as they would do normally. | Other | Treatment as usual |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index as calculated from Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS).
Time frame: On day 0, 30, 60 and 90
The primary endpoint is to evaluate the change in the Western Ontario and McMaster Universities Osteoarthritis Index as calculated from Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS).This change will be calculated over day 0 until week 12. Where the higher scores on the HOOS and KOOS indicate worse pain, stiffness, and functional limitations. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
7 secondary outcomes
Pain index as in western Ontario and McMaster's Osteoarthritis Index as derived from Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS).
Time frame: On day 0, 30, 60 and 90
Functionality index as in western Ontario and McMaster's Osteoarthritis Index as derived from Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS).
Time frame: On day 0, 30, 60 and 90
Stiffness score as in western Ontario and McMaster's Osteoarthritis Index as derived from Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS).
Time frame: On day 0, 30, 60 and 90
Patient-Reported Outcomes Measurement Information System (PROMIS Global 10)
Time frame: Information collected on day 0, 30, 60 and 90
Inclination towards healthcare utilization
Time frame: Information collected only on day 0
Self-reported number of lost workdays
Time frame: Information collected only on day 0 and day 90
Pain medication intake
Time frame: Information collected on day 0, 30, 60 and 90
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 16 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Kevin J Choo, MD principal investigator
Orthopaedic and Neurosurgery Specialists, 6 Greenwich Office Park, Greenwich, CT 06831
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kaia hip and knee pain application and Treatment as usual in people with Knee Osteoarthritis and Hip Osteoarthritis, run by Kaia Health Software 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 7 inclusion and 8 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 16 Aug 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?
Western Ontario and McMaster Universities Osteoarthritis Index as calculated from Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS). (time frame: On day 0, 30, 60 and 90). 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 16 Aug 2022.