TelemedicineIMIDOCNCT06273306
Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC)
A study testing IMIDOC in people with Telemedicine and Telehealth, run by Instituto de Investigación Hospital Universitario La Paz.
Trial summary
The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Telemedicine, Telehealth, eHealth
- What is being tested?
- IMIDOC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis with Rheumatoid Arthritis or Spondylarthritis
- Treatment with biologic or targeted disease modifying antirheumatic drugs.
- Ability to use smartphone.
Who cannot join
- only patients with conditions that hinder or prevent the use of a mobile application (blindness, mental retardation, dementia, digitalfilliteracy).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model
The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up.
This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and Spondylarthritis (SpA) from five Spanish Hospitals. Patients will be followed-up by the MAM protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (App) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their patients; clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analogue scale for pain and electronic patient reported outcome reports (ePROs) will be collected for all subjects. In the MAM group, these items will be self-assessed both by the mobile App and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. Patients will be able to report any incidence related to their disease or treatment through the mobile App.
- Conditions
- Telemedicine, Telehealth, eHealth, Rheumatic Diseases, Arthritis, Rheumatoid, Spondylarthritis
- Being tested
- IMIDOC
- Medical subject headings
- Rheumatic Diseases, Arthritis, Rheumatoid, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMIDOCDevice
Patient´s Mobile App for recording clinical data
| Study group | Role | What they receive |
|---|---|---|
| Digital care | Experimental | User of mobile APP for telemonitoring Receives: Device: IMIDOC |
| Traditional care | No intervention | Monitoring in face-to-face visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the primary objective, composite endpoints that consider the viability, adherence and degree of satisfaction of the MAM are included
- Number of interactions in activity and electronic patient reported outcomes (ePRO) questionnaires per month.
- Number of reported incidences per month.
- Average time to contact the patient after reporting an incident.
- Average number of interactions in educational material and other content per month.
- Adherence to follow-up through the mixed atenttion model (MAM) will be evaluated through the number of visits and time per visit to the digital platform.
- Percentage of incidents resolved telematically.
- Average weekly hours that the digital clinician takes to review the professional's website and resolve incidents
- Professionals and patients´ satisfaction will be assessed through the Net-Promoter-Score (NPS). Values from 0 to 6 ( detractors), 6-8 ( passives) and 9-10 promoters.
Measured: 24 months
Secondary outcomes (1)
To identify features associated with adherence to follow-up through the MAM.
- A 22-item self-administered survey adapted from the Unified Theory of Acceptance and Use of Technology (UTAUT) model will be used to measure app acceptance and intention to use: the variables will measured with 7-point scales for all model components as in the original UTAUT, where 1 equalled the negative end (fully disagree) and 7 the positive end of the scale (fully agree).
- Agreement between patients' self-assessment and clinician assessment will be assessed comparing face-to-face visits at 6-months intervals with the closest assessment in the digital solution.
- Number of face-to-face visits are avoided with the mixed atenttion model (MAM) in patients with stable disease activity.
- Patients' eHealth literacy will be measured using the validated Spanish version of the eHealth Literacy Scale (eHEALS), measured on a 5-point scale in the range from 1 (strongly disagree) to 5 (strongly agree)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start15 Mar 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chamaida Plasencia-Rodríguez, PhD, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273306
- Sponsor's protocol ID
- HULP.PI-4519
- Other IDs
- PI22/00777
- Acronym
- IMIDOC
- Status last verified
- Dec 2023
- First submitted
- 8 Jan 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benavent D, Iniesta-Chamorro JM, Novella-Navarro M, Perez-Martinez M, Martinez-Sanchez N, Kaffati M, Juarez-Garcia M, Molinari-Perez M, Gonzalez-Torbay A, Gutierrez M, Lopez-Juanes N, Navarro-Compan V, Monjo-Henry I, Rodriguez-Rosales G, Bachiller J, Calvo-Aranda E, Michelena X, Berbel-Arcobe L, Balsa A; IMIDOC Research Team; Gomez EJ, Plasencia-Rodriguez C. Digital Health Intervention for Patient Monitoring in Immune-Mediated Inflammatory Diseases: Cocreation and Feasibility Study of the IMIDoc Platform. JMIR Hum Factors. 2025 Apr 21;12:e58095. doi: 10.2196/58095.
PubMed 40267421Novella-Navarro M, Iniesta-Chamorro JM, Benavent D, Bachiller-Corral J, Calvo-Aranda E, Borrell H, Berbel-Arcobe L, Navarro-Compan V, Michelena X, Lojo-Oliveira L, Arroyo-Palomo J, Diaz-Almiron M, Garcia Garcia V, Monjo-Henry I, Gomez Gonzalez CM, Gomez EJ, Balsa A, Plasencia-Rodriguez C. Toward Telemonitoring in Immune-Mediated Inflammatory Diseases: Protocol for a Mixed Attention Model Study. JMIR Res Protoc. 2024 Apr 22;13:e55829. doi: 10.2196/55829.
PubMed 38501508
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model
- ClinicalTrials.gov ID
- NCT06273306
- Acronym / sponsor ID
- IMIDOC / HULP.PI-4519
- Conditions
- Telemedicine, Telehealth, eHealth, Rheumatic Diseases, Arthritis, Rheumatoid, Spondylarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Feb 2024 (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 main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up.
This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and Spondylarthritis (SpA) from five Spanish Hospitals. Patients will be followed-up by the MAM protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (App) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their patients; clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analogue scale for pain and electronic patient reported outcome reports (ePROs) will be collected for all subjects. In the MAM group, these items will be self-assessed both by the mobile App and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. Patients will be able to report any incidence related to their disease or treatment through the mobile App.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital care | Experimental | Device: IMIDOCUser of mobile APP for telemonitoring |
| Traditional care | No intervention | –Monitoring in face-to-face visits |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis with Rheumatoid Arthritis or Spondylarthritis
- Treatment with biologic or targeted disease modifying antirheumatic drugs.
- Ability to use smartphone.
Key exclusion criteria (1 listed)
- only patients with conditions that hinder or prevent the use of a mobile application (blindness, mental retardation, dementia, digitalfilliteracy).
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 |
|---|---|---|
| IMIDOCPatient´s Mobile App for recording clinical data | Device | Digital care |
Primary outcome
To assess the primary objective, composite endpoints that consider the viability, adherence and degree of satisfaction of the MAM are included
Time frame: 24 months
* Number of interactions in activity and electronic patient reported outcomes (ePRO) questionnaires per month. * Number of reported incidences per month. * Average time to contact the patient after reporting an incident. * Average number of interactions in educational material and other content per month. * Adherence to follow-up through the mixed atenttion model (MAM) will be evaluated through the number of visits and time per visit to the digital platform. * Percentage of incidents resolved telematically. * Average weekly hours that the digital clinician takes to review the professional's website and resolve incidents * Professionals and patients´ satisfaction will be assessed through the Net-Promoter-Score (NPS). Values from 0 to 6 ( detractors), 6-8 ( passives) and 9-10 promoters.
1 secondary outcome
To identify features associated with adherence to follow-up through the MAM.
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Derived from this study: PubMed 40267421Benavent D, Iniesta-Chamorro JM, Novella-Navarro M, Perez-Martinez M, Martinez-Sanchez N, Kaffati M, Juarez-Garcia M, Molinari-Perez M, Gonzalez-Torbay A, Gutierrez M, Lopez-Juanes N, Navarro-Compan V, Monjo-Henry I, Rodriguez-Rosales G, Bachiller J, Calvo-Aranda E, Michelena X, Berbel-Arcobe L, Balsa A; IMIDOC Research Team; Gomez EJ, Plasencia-Rodriguez C. Digital Health Intervention for Patient Monitoring in Immune-Mediated Inflammatory Diseases: Cocreation and Feasibility Study of the IMIDoc Platform. JMIR Hum Factors. 2025 Apr 21;12:e58095. doi: 10.2196/58095.
- Derived from this study: PubMed 38501508Novella-Navarro M, Iniesta-Chamorro JM, Benavent D, Bachiller-Corral J, Calvo-Aranda E, Borrell H, Berbel-Arcobe L, Navarro-Compan V, Michelena X, Lojo-Oliveira L, Arroyo-Palomo J, Diaz-Almiron M, Garcia Garcia V, Monjo-Henry I, Gomez Gonzalez CM, Gomez EJ, Balsa A, Plasencia-Rodriguez C. Toward Telemonitoring in Immune-Mediated Inflammatory Diseases: Protocol for a Mixed Attention Model Study. JMIR Res Protoc. 2024 Apr 22;13:e55829. doi: 10.2196/55829.
- 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.
Chamaida Plasencia-Rodríguez, PhD principal investigator
Hospital Universitario La Paz
Questions about this trial
What is this clinical trial studying?
A study testing IMIDOC in people with Telemedicine and Telehealth, run by Instituto de Investigación Hospital Universitario La Paz.
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 1 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: opening soon, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chamaida Plasencia-Rodríguez, PhD (917277108, chamiplaro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the primary objective, composite endpoints that consider the viability, adherence and degree of satisfaction of the MAM are included (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06273306, which also lists 2 linked publications.
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 22 Feb 2024.