Psoriatic ArthritisNCT05652608
Stronger Together Psoriatic Arthritis Wellness Study
An observational study of Psoriatic Arthritis, run by Global Healthy Living Foundation at 1 site in United States.
Trial summary
Patients diagnosed with psoriatic arthritis (PsA) confront decisions about how to treat their disease, interact with their health care providers, and modify lifestyle choices that may improve treatment outcomes. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Immune Strength
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 1 Mar 2026
- Phase
- Observational
- 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 19 years and older
- All sexes
- Adult, Older adult
Study population: Participants will be recruited by the Global Healthy Living Foundation (GHLF). GHLF is the parent organization of the CreakyJoints® (CJ) arthritis patient community and primary site for PatientSpot Patient Powered Research Network (PPRN), known as PatientSpot®. PatientSpot is a subset of CreakyJoints members who have expressed interest in participating in research and signed an informed consent form to participate in the PPRN and its associated research. Any individuals recruited from CreakyJoints or Facebook, who are not already members of PatientSpot will be encouraged to join the PatientSpot registry research app, but will not be required to do so in order to participate in the study.
Who may be able to join
- Participants must be residents of the United States and United States territories
- Participants must be age 19 and above for United States resident or 21 and above for Puerto Rico residents
- Participants must have a self-reported diagnosis of psoriatic arthritis (PsA) (as indicated by survey screening questions)
- Participants must be taking prescribed medication to treat their PsA
- Participants must have access to a computer or smartphone to take the survey
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Global Healthy Living Foundation
Upper Nyack, New York, 10960
Ben Nowell, Phd, 845-348-0400, bnowell@ghlf.org
Shilpa Venkatachalam, Phd, (845) 348 0400, svenky@ghlf.org
About this study
Patients diagnosed with psoriatic arthritis (PsA) confront decisions about how to treat their disease, interact with their health care providers, and modify lifestyle choices that may improve treatment outcomes. With sponsorship support from Janssen and in partnership with the Cleveland Clinic, this survey study will seek to understand and examine whether people living with PsA are interested in and motivated to participate in wellness activities. This cross-sectional observational survey study will help researchers and clinicians to better understand what some of the barriers and facilitators experienced by patients are when considering participation in guided online wellness activities.
People that qualify for the study and complete a 10-minute survey will be invited to participate in Immune Strength, an online wellness program developed by the Cleveland Clinic. Immune Strength is a free 10-week program for creating better habits for a more resilient immune system. By following this program, participants will have the opportunity to learn about how to develop strategies and implement behavior changes for healthier immune functioning.
Participants will be recruited by the Global Healthy Living Foundation (GHLF). GHLF is the parent organization of the CreakyJoints® (CJ) arthritis patient community and primary site for the PCORI-funded Arthritis Patient Partnership with Comparative Effectiveness Researchers (AR-PoWER) Patient Powered Research Network (PPRN), known as ArthritisPower®. ArthritisPower is a subset of CreakyJoints members who have expressed interest in participating in research and signed an informed consent form to participate in the PPRN and its associated research. Any individuals recruited from CreakyJoints or Facebook, who are not already members of ArthritisPower will be encouraged to join the ArthritisPower registry research app, but will not be required to do so in order to participate in the study.
- Conditions
- Psoriatic Arthritis
- Being tested
- Immune Strength
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune StrengthBehavioural
Multi-week wellness program provided by the Cleveland Clinic
| Study group | Role | What they receive |
|---|---|---|
| Particpants | participating in Immune Strength, a multi-week wellness program Receives: Behavioral: Immune Strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interest in Wellness Programs
Percent of participants interested in participating in a wellness program to complement treatment for controlling their disease
Measured: Day 1
Barriers to Wellness
Percent of participants that experience barriers in using wellness to help manage their disease
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start1 Mar 2022
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global Healthy Living Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652608
- Sponsor's protocol ID
- Pro00062932
- Status last verified
- Sep 2024
- First submitted
- 7 Dec 2022
- Last updated
- 26 Sep 2024
- 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 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stronger Together Psoriatic Arthritis Wellness Study
- ClinicalTrials.gov ID
- NCT05652608
- Acronym / sponsor ID
- Pro00062932
- Conditions
- Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Global Healthy Living FoundationUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 15 Dec 2022 (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.
Patients diagnosed with psoriatic arthritis (PsA) confront decisions about how to treat their disease, interact with their health care providers, and modify lifestyle choices that may improve treatment outcomes. With sponsorship support from Janssen and in partnership with the Cleveland Clinic, this survey study will seek to understand and examine whether people living with PsA are interested in and motivated to participate in wellness activities. This cross-sectional observational survey study will help researchers and clinicians to better understand what some of the barriers and facilitators experienced by patients are when considering participation in guided online wellness activities.
People that qualify for the study and complete a 10-minute survey will be invited to participate in Immune Strength, an online wellness program developed by the Cleveland Clinic. Immune Strength is a free 10-week program for creating better habits for a more resilient immune system. By following this program, participants will have the opportunity to learn about how to develop strategies and implement behavior changes for healthier immune functioning.
Participants will be recruited by the Global Healthy Living Foundation (GHLF). GHLF is the parent organization of the CreakyJoints® (CJ) arthritis patient community and primary site for the PCORI-funded Arthritis Patient Partnership with Comparative Effectiveness Researchers (AR-PoWER) Patient Powered Research Network (PPRN), known as ArthritisPower®. ArthritisPower is a subset of CreakyJoints members who have expressed interest in participating in research and signed an informed consent form to participate in the PPRN and its associated research. Any individuals recruited from CreakyJoints or Facebook, who are not already members of ArthritisPower will be encouraged to join the ArthritisPower registry research app, but will not be required to do so in order to participate in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Particpants | – | Behavioral: Immune Strengthparticipating in Immune Strength, a multi-week wellness program |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited by the Global Healthy Living Foundation (GHLF). GHLF is the parent organization of the CreakyJoints® (CJ) arthritis patient community and primary site for PatientSpot Patient Powered Research Network (PPRN), known as PatientSpot®. PatientSpot is a subset of CreakyJoints members who have expressed interest in participating in research and signed an informed consent form to participate in the PPRN and its associated research. Any individuals recruited from CreakyJoints or Facebook, who are not already members of PatientSpot will be encouraged to join the PatientSpot registry research app, but will not be required to do so in order to participate in the study.
Key inclusion criteria (5 listed)
- Participants must be residents of the United States and United States territories
- Participants must be age 19 and above for United States resident or 21 and above for Puerto Rico residents
- Participants must have a self-reported diagnosis of psoriatic arthritis (PsA) (as indicated by survey screening questions)
- Participants must be taking prescribed medication to treat their PsA
- Participants must have access to a computer or smartphone to take the survey
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Immune StrengthMulti-week wellness program provided by the Cleveland Clinic | Behavioural | Particpants |
Primary outcome
Interest in Wellness Programs
Time frame: Day 1
Percent of participants interested in participating in a wellness program to complement treatment for controlling their disease
Barriers to Wellness
Time frame: Day 1
Percent of participants that experience barriers in using wellness to help manage their disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by Global Healthy Living Foundation 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 0 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: status not confirmed, as of the sponsor's last update on 26 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shilpa Venkatachalam, Phd ((845) 348 0400, svenky@ghlf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interest in Wellness Programs (time frame: Day 1). The study lists 2 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 26 Sep 2024.