TelemedicineTHRIVENCT05483855
Telehealth-delivered HealthcaRe to ImproVe Care
An observational study of Telemedicine, run by Attune Health Research, Inc. at 1 site in United States.
Trial summary
Objective 1: Evaluate patients' satisfaction with their telehealth care and determine factors associated with satisfaction. Objective 2: Deploy PROs and patient self-assessment tools, specifically a patient-facing instructional in-app tool that instructs RA patients how to perform self-assessment examinations to… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Telemedicine
- What is being tested?
- Objective 1 Only: Telehealth Satisfaction Survey and Objective 2 Only: ArthritisPower Joint Assessment
- How many people
- 1,580 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2023to Apr 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults with Rheumatoid Arthritis seen in a Rheumatology Clinic.
Who may be able to join
- Must be 19 years or older.
- Must have a prior diagnosis of Rheumatoid Arthritis.
- Must be able to read and write in English or Spanish.
Who cannot join
- Younger than 19 years of age
- Does not have a prior diagnosis of Rheumatoid Arthritis.
- Unable to read and write in English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Attune Health Research Inc
Beverly Hills, California, 90211
Swamy Venuturupalli
About this study
Official title: Telehealth-delivered HealthcaRe to ImproVe Care (THRIVE) as an Integral Component of Remote Therapeutic Monitoring (RTM)
Objective 1:
Evaluate patients' satisfaction with their telehealth care and determine factors associated with satisfaction.
Objective 2:
Deploy PROs and patient self-assessment tools, specifically a patient-facing instructional in-app tool that instructs RA patients how to perform self-assessment examinations to observe and report the number of tender and swollen joint counts.
Read the detailed description
Objective 1:
Any rheumatology patients, seen and treated by participating physicians, who are 19 years and older with the target condition(s) of interest and are pre-scheduled for a telehealth visit, are eligible to participate and will be invited. The desired enrollment target is 1500 respondents shared amongst the 12 participating rheumatologists. One week before the scheduled telehealth visit, patients who have agreed to participate will receive electronic communication from participating physicians' offices notifying them that they will be asked to complete a survey about their satisfaction with their telehealth visit after its conclusion. Within approximately 1 business day following the standard of care telehealth visit, participants will be sent a text via an Electronic Data Capture system inviting them to participate in the survey. Upon clicking on the survey link provided in the text message, participants will be prompted to rate their level of satisfaction with their telehealth visit on a scale of 1 to 10, with a score of 1 denoting low satisfaction and a score of 10 denoting high satisfaction. Selection of a score of 8 or lower will prompt participants to answer additional subsequent questions that queries them to explain the reasons for their unsatisfactory patient experience. Data from the surveys will be linked back to participants; electronic health record data to evaluate characteristics such as age, health conditions, disease activity, treatments, social determinants of health, multi-morbidity, PROs, medicated based multi-morbidity, driving distance from a patient's home to the physician's office, rural/urban status, disease indication for the telehealth visit associated with the unsatisfactory telehealth encounter. Data from participant surveys will be linked with Electronic Health Record (EHR) data to analyze factors associated with satisfaction. Logistic regression with generalized estimating equations (GEE) will be used to model factors associated with low telehealth satisfaction, controlling for site clustering.
Objective 2:
8-10 patients with Rheumatoid Arthritis from each site of the same 12 participating physicians who have already-scheduled in-office visits will be invited to participate. The target recruitment goal is approximately 100 patients, which, after accounting for attrition would allow for an analytic sample of about 70-80 Rheumatoid Arthritis patients. Patients will be recruited via in-person solicitation, email, patient portal, text-messaging, or a combination of these. Interested patients will be sent a link by email or text message to join the ArthritisPower registry after which a unique and custom generated password will be generated that has no relationship to identifying patient information. After registration, participants will be prompted to complete the in-app instructional tool for self-assessment examination of their joints in addition to several RA-related patient reported outcomes. The assessment in ArthritisPower must be completed as soon as participant has received the link to register for the application. Within 3 business days of the ArthritisPower self-assessment, participants will have their scheduled in-office examination of their joints by their physician to collect the provider joint examination findings and other physician data in an EDC system. If there has been more than a 7-business day gap between the patient self-assessment in the ArthritisPower app, and the in-person exam, that patient will be ineligible for analysis and will be replaced. The correlation between patient joint count will be analyzed. The investigators will examine and compare the patient and rheumatology provider's render and swollen joint count summed scores and Perason and Spearman's correlation coefficient.
- Conditions
- Telemedicine
- Being tested
- Objective 1 Only: Telehealth Satisfaction Survey, Objective 2 Only: ArthritisPower Joint Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Objective 1 Only: Telehealth Satisfaction SurveyOther
Participants must complete a telehealth satisfaction survey rating their standard of care telehealth visit on a scale of 1 to 10, with 1 denoting low satisfaction and 10 denoting high satisfaction.
Objective 2 Only: ArthritisPower Joint AssessmentOther
RA patients must complete a self-assessment examination of their joints using the ArthritisPower app prior to their in-office visit, where a repeat joint assessment is performed by participating physician.
| Study group | Role | What they receive |
|---|---|---|
| Objective 1: Telehealth Visit | Any rheumatology patient, seen and treated by a participating physician, who is 19 years and older, with the target condition(s) of interest, and is already scheduled for a telehealth visit. Receives: Other: Objective 1 Only: Telehealth Satisfaction Survey | |
| Objective 2: ArthritisPower App | Patients diagnosed with Rheumatoid Arthritis who already have a pre-scheduled in-office visit. Receives: Other: Objective 2 Only: ArthritisPower Joint Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between patient joint count and provider joint count
The investigators will examine and compare the patient and rheumatology provider's tender and swollen joint count summed scores and Pearson and Spearman's correlation coefficient (if the data is non-normally distributed). The investigators will also calculate a typical Clinical Disease Index (CDAI) for RA which is a composite score of TJC28 + SJC28 + Patient Global + Provider Global and correlate with the patient [p] CDAI ([p]TJC28 + [p]SJC28 + Patient Global + Provider Global). Disease remission for RA is denoted by a CDAI composite score of less than or equal to 2.8 while high RA disease activity is denoted by a CDAI score of 22 or greater. The investigators will also compute weighted kappa statistics, comparing the 4x4 table of remission, low moderate, and high disease activity categories, using the traditional CDAI cut points (2.8, 10, and 22).
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start3 Jan 2023
- Primary completionDec 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attune Health Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rheumatology Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483855
- Sponsor's protocol ID
- THRIVERTM
- Acronym
- THRIVE
- Status last verified
- Aug 2024
- First submitted
- 27 Jul 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth-delivered HealthcaRe to ImproVe Care (THRIVE) as an Integral Component of Remote Therapeutic Monitoring (RTM)
- ClinicalTrials.gov ID
- NCT05483855
- Acronym / sponsor ID
- THRIVE / THRIVERTM
- Conditions
- Telemedicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,580 participants (estimated)
- Lead sponsor
- Attune Health Research, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Rheumatology Research Foundation
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 2 Aug 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.
Objective 1:
Evaluate patients' satisfaction with their telehealth care and determine factors associated with satisfaction.
Objective 2:
Deploy PROs and patient self-assessment tools, specifically a patient-facing instructional in-app tool that instructs RA patients how to perform self-assessment examinations to observe and report the number of tender and swollen joint counts.
Detailed description
Objective 1:
Any rheumatology patients, seen and treated by participating physicians, who are 19 years and older with the target condition(s) of interest and are pre-scheduled for a telehealth visit, are eligible to participate and will be invited. The desired enrollment target is 1500 respondents shared amongst the 12 participating rheumatologists. One week before the scheduled telehealth visit, patients who have agreed to participate will receive electronic communication from participating physicians' offices notifying them that they will be asked to complete a survey about their satisfaction with their telehealth visit after its conclusion. Within approximately 1 business day following the standard of care telehealth visit, participants will be sent a text via an Electronic Data Capture system inviting them to participate in the survey. Upon clicking on the survey link provided in the text message, participants will be prompted to rate their level of satisfaction with their telehealth visit on a scale of 1 to 10, with a score of 1 denoting low satisfaction and a score of 10 denoting high satisfaction. Selection of a score of 8 or lower will prompt participants to answer additional subsequent questions that queries them to explain the reasons for their unsatisfactory patient experience. Data from the surveys will be linked back to participants; electronic health record data to evaluate characteristics such as age, health conditions, disease activity, treatments, social determinants of health, multi-morbidity, PROs, medicated based multi-morbidity, driving distance from a patient's home to the physician's office, rural/urban status, disease indication for the telehealth visit associated with the unsatisfactory telehealth encounter. Data from participant surveys will be linked with Electronic Health Record (EHR) data to analyze factors associated with satisfaction. Logistic regression with generalized estimating equations (GEE) will be used to model factors associated with low telehealth satisfaction, controlling for site clustering.
Objective 2:
8-10 patients with Rheumatoid Arthritis from each site of the same 12 participating physicians who have already-scheduled in-office visits will be invited to participate. The target recruitment goal is approximately 100 patients, which, after accounting for attrition would allow for an analytic sample of about 70-80 Rheumatoid Arthritis patients. Patients will be recruited via in-person solicitation, email, patient portal, text-messaging, or a combination of these. Interested patients will be sent a link by email or text message to join the ArthritisPower registry after which a unique and custom generated password will be generated that has no relationship to identifying patient information. After registration, participants will be prompted to complete the in-app instructional tool for self-assessment examination of their joints in addition to several RA-related patient reported outcomes. The assessment in ArthritisPower must be completed as soon as participant has received the link to register for the application. Within 3 business days of the ArthritisPower self-assessment, participants will have their scheduled in-office examination of their joints by their physician to collect the provider joint examination findings and other physician data in an EDC system. If there has been more than a 7-business day gap between the patient self-assessment in the ArthritisPower app, and the in-person exam, that patient will be ineligible for analysis and will be replaced. The correlation between patient joint count will be analyzed. The investigators will examine and compare the patient and rheumatology provider's render and swollen joint count summed scores and Perason and Spearman's correlation coefficient.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Objective 1: Telehealth Visit | – | Other: Objective 1 Only: Telehealth Satisfaction SurveyAny rheumatology patient, seen and treated by a participating physician, who is 19 years and older, with the target condition(s) of interest, and is already scheduled for a telehealth visit. |
| Objective 2: ArthritisPower App | – | Other: Objective 2 Only: ArthritisPower Joint AssessmentPatients diagnosed with Rheumatoid Arthritis who already have a pre-scheduled in-office visit. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Rheumatoid Arthritis seen in a Rheumatology Clinic.
Key inclusion criteria (3 listed)
- Must be 19 years or older.
- Must have a prior diagnosis of Rheumatoid Arthritis.
- Must be able to read and write in English or Spanish.
Key exclusion criteria (3 listed)
- Younger than 19 years of age
- Does not have a prior diagnosis of Rheumatoid Arthritis.
- Unable to read and write in English or Spanish
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 |
|---|---|---|
| Objective 1 Only: Telehealth Satisfaction SurveyParticipants must complete a telehealth satisfaction survey rating their standard of care telehealth visit on a scale of 1 to 10, with 1 denoting low satisfaction and 10 denoting high satisfaction. | Other | Objective 1: Telehealth Visit |
| Objective 2 Only: ArthritisPower Joint AssessmentRA patients must complete a self-assessment examination of their joints using the ArthritisPower app prior to their in-office visit, where a repeat joint assessment is performed by participating physician. | Other | Objective 2: ArthritisPower App |
Primary outcome
Correlation between patient joint count and provider joint count
Time frame: Immediately after the intervention
The investigators will examine and compare the patient and rheumatology provider's tender and swollen joint count summed scores and Pearson and Spearman's correlation coefficient (if the data is non-normally distributed). The investigators will also calculate a typical Clinical Disease Index (CDAI) for RA which is a composite score of TJC28 + SJC28 + Patient Global + Provider Global and correlate with the patient [p] CDAI ([p]TJC28 + [p]SJC28 + Patient Global + Provider Global). Disease remission for RA is denoted by a CDAI composite score of less than or equal to 2.8 while high RA disease activity is denoted by a CDAI score of 22 or greater. The investigators will also compute weighted kappa statistics, comparing the 4x4 table of remission, low moderate, and high disease activity categories, using the traditional CDAI cut points (2.8, 10, and 22).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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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 Telemedicine, run by Attune Health Research, Inc. 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 3 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: status not confirmed, as of the sponsor's last update on 6 Aug 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 Natalie Fortune (3106520010, research.admin@attunehealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between patient joint count and provider joint count (time frame: Immediately after the intervention). 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 6 Aug 2024.