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TelemedicineTHRIVENCT05483855

Telehealth-delivered HealthcaRe to ImproVe Care

An observational study of Telemedicine, run by Attune Health Research, Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Attune Health Research Inc

    Beverly Hills, California, 90211

    Swamy Venuturupalli

    Recruiting

Other trials in United States

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 groups in NCT05483855
Study groupRoleWhat they receive
Objective 1: Telehealth VisitAny 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 AppPatients 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.

  1. 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.

  1. First posted2 Aug 2022
  2. Study start3 Jan 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionApr 2025 (estimated)

Resources

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)
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

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.

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