Rheumatoid ArthritiseducARNCT05425485
educAR: Improving Adherence in Rheumatoid Arthritis
A study testing Multi-component intervention in people with Rheumatoid Arthritis, run by María Ahijón at 15 sites in Spain.
Trial summary
Based on recent guidelines, the investigators have developed a parallel (patient and physician) educational web-based tool. To prove its effectiveness, the investigators have designed a cluster clinical trial of a 6-month duration in which 15 centres will be randomised to receive access and instruction on the strategy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Multi-component intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 15 sitesSpain
- Study dates
- 1 Oct 2022to 31 Oct 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (>18 years of age)
- RA according to diagnosis recorded in clinical records
- < 2 years since diagnosis of rheumatoid arthritis.
- Independent daily living.
Who cannot join
- Cognitive impairment
- Language barriers
- Impossibility of follow-up
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Hospital Universitari Germans Trias i Pujol
Badalona
Hospital Universitario Reina Sofía
Córdoba
Hospital General Universitario de Elda
Elda
Hospital Universitari d'Igualada
Igualada
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat
Hospital de la Princesa
Madrid, 28006
Hospital Universitario Ramón y Cajal
Madrid
Hospital General Universitario de Málaga
Málaga
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia
Hospital Universitario de Navarra
Pamplona
Hospital Universitario de Canarias
San Cristóbal de La Laguna
Hospital Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife
Hospital Universitario Virgen Macarena
Seville
Hospital Mutua de Terrassa
Terrassa
Hospital Clínico Universitario de Valencia
Valencia
About this study
Official title: educAR: Validation of a Double Educational Strategy to Improve Therapeutic Adherence in Rheumatoid Arthritis.
Based on recent guidelines, the investigators have developed a parallel (patient and physician) educational web-based tool. To prove its effectiveness, the investigators have designed a cluster clinical trial of a 6-month duration in which 15 centres will be randomised to receive access and instruction on the strategy or to continue standard care.
The trial endpoint is adherence at the patient level, for which each centre will recruit 15 consecutive patients and measure adherence (medication, physical activity, Mediterranean diet) and disease activity as of baseline and 6 months after.
Read the detailed description
Treatment adherence in patients with rheumatoid arthritis (RA) is estimated to be between 50-80%. Non-adherence is a health problem with a significant economic impact. The causes of non-adherence are multiple and require individualized care that is difficult both to implement at the professional level and to prove effective.
Based on recent international recommendations and previous work from the research team, plus a qualitative study with multi-stakeholders, the investigators have designed a web-based strategy to avoid non-adherence in RA.
The primary objective is to evaluate the effectiveness of an evidence-based, consensus-based adherence intervention strategy for improving adherence in patients with RA.
Secondary objectives are to evaluate the impact on disease activity, healthy habits (diet/exercise), cardiovascular risk factors, quality of life and patient satisfaction.
The investigators have designed a cluster clinical trial of 6-month duration.
Fifteen centres will be randomised to receive access and instruction on the strategy or to continue standard care. Centre recruitment is on a voluntary basis, understanding that access to the educational tool will be delayed in case of being assigned to the control group.
The intervention is a web-based tool with educational and practical materials for the patient and for the physician (this part will be protected with a password during the duration of the trial). Physicians (prescribers or non-prescribers) in centres assigned to the intervention will be invited to be instructed on the materials (text, videos, checklists, calendars, etc).
Control will be standard care.
Each centre will recruit 15 consecutive adult patients with rheumatoid arthritis (as stated in the clinical records), less than 2 years since diagnosis and living independently.
The primary outcome will be therapeutic adherence (patient-level), defined as a score ≥ 80% in the Compliance Questionnaire on Rheumatology (CQR) and in the Adherence Medication Scale (RAM).
Secondary outcomes will be adherence to physical activity, a Mediterranean diet, lifestyle changes and disease activity.
Accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 79 patients per group are required, assuming that the initial proportion of adherent patients is 70% and at the end of the intervention, it would increase to 90% (only in the intervention group, in the control it would not change). A lost-to-follow-up rate of 25% has been estimated.
If 10 centres are selected to have at least 5 clusters for each group, this would correspond, rounding up, to 16 patients per centre, or a total of 160 patients.
The effect of the intervention on adherence to treatment will be refuted by the chi-square test and measured by relative risk (RR) and difference of proportions.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Multi-component intervention
- Keywords
- Therapeutic adherence, Patient education
- Medical subject headings
- Arthritis, Rheumatoid, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component interventionBehavioural
Also called EducAR
Web-based strategy with processes, materials, and patient and doctor education formats.
| Study group | Role | What they receive |
|---|---|---|
| EducAR strategy | Active comparator | Healthcare personnel involved in the care of patients with RA in the selected centres will be provided with access to a website and instructed in its use in a videoconference. The website includes a training section for healthcare professionals and another for patients. The former includes explanatory videos on how to manage doctor-patient communication and to facilitate adherence and what not to do, tools to explain treatment options (shared decision aids) and links to key documents. The patient section includes information for patients (downloadable in leaflet format), medication calendars and disease diaries, videos explaining medication administration in RA and links to patient associations, among other tools.
Both access to the website and its materials and to the instruction session will be open to all those involved in the corresponding service, but will not be mandatory. Receives: Behavioral: Multi-component intervention |
| Standard of care | No intervention | Physicians in the control group will not be instructed and will have no access to the materials included in the physician section of the webpage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with therapeutic adherence.
Score ≥ 80% both in the Compliance Questionnaire in Rheumatology (CQR) plus the in Adherence Medication Scale (RAM).
Measured: 6 months
Secondary outcomes (5)
Adherence to physical exercise
Measured using the Exercise Attitude Questionnaire-18 (EAQ-18). Final result is expressed out of 100 point. High scores indicate great adherence to exercise.
Measured: 6 months
Adherence to mediterranean diet
Measured using the Mediterranean Diet Adherence Screener (MEDAS).Patients with a score <9 will be considered poor adherents to the Mediterranean diet.
Measured: 6 months
Disease activity
Measured using disease activity score of 28 joints (DAS28-ESR).This index stratifies disease activity into: high (>5.1), moderate (3.2-5.1), low (2.6- <3.2) and remission (<2.6).
Measured: 6 months
Degree of satisfaction with medical care
Measured using the Arthritis Satisfaction questionnaire. Final result is expressed in a range from 0 to 100 points. Higher scores indicate greater satisfaction.
Measured: 6 months
Health-related quality of life measured using the Short-form12 (SF-12) version 2 questionnaire, a shortened version of the SF-36
Measured with the SF-12 version 2. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Oct 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- María Ahijón
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Musculoesquelética SL
- Responsible party
- Sponsor-investigator, María Ahijón, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Investigators
- María Ahijon, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425485
- Sponsor's protocol ID
- 4710
- Acronym
- educAR
- Status last verified
- Nov 2023
- First submitted
- 9 Jun 2022
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahijon Lana M, Sivera Mascaro F, Fernandez-Nebro A, Muntadas Castello S, Perez M, Oton T, Garcia de Yebenes MJ, Carmona L; EDUCAR Group. EducAR: implementing a multicomponent strategy to improve therapeutic adherence in rheumatoid arthritis. RMD Open. 2025 Feb 27;11(1):e004989. doi: 10.1136/rmdopen-2024-004989.
PubMed 40021204
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- educAR: Validation of a Double Educational Strategy to Improve Therapeutic Adherence in Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT05425485
- Acronym / sponsor ID
- educAR / 4710
- Conditions
- Rheumatoid Arthritis
- Keywords
- Therapeutic adherence, Patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- María AhijónUniversity, hospital or other
- Collaborators
- Instituto de Salud Musculoesquelética SL
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 21 Jun 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.
Based on recent guidelines, the investigators have developed a parallel (patient and physician) educational web-based tool. To prove its effectiveness, the investigators have designed a cluster clinical trial of a 6-month duration in which 15 centres will be randomised to receive access and instruction on the strategy or to continue standard care.
The trial endpoint is adherence at the patient level, for which each centre will recruit 15 consecutive patients and measure adherence (medication, physical activity, Mediterranean diet) and disease activity as of baseline and 6 months after.
Detailed description
Treatment adherence in patients with rheumatoid arthritis (RA) is estimated to be between 50-80%. Non-adherence is a health problem with a significant economic impact. The causes of non-adherence are multiple and require individualized care that is difficult both to implement at the professional level and to prove effective.
Based on recent international recommendations and previous work from the research team, plus a qualitative study with multi-stakeholders, the investigators have designed a web-based strategy to avoid non-adherence in RA.
The primary objective is to evaluate the effectiveness of an evidence-based, consensus-based adherence intervention strategy for improving adherence in patients with RA.
Secondary objectives are to evaluate the impact on disease activity, healthy habits (diet/exercise), cardiovascular risk factors, quality of life and patient satisfaction.
The investigators have designed a cluster clinical trial of 6-month duration.
Fifteen centres will be randomised to receive access and instruction on the strategy or to continue standard care. Centre recruitment is on a voluntary basis, understanding that access to the educational tool will be delayed in case of being assigned to the control group.
The intervention is a web-based tool with educational and practical materials for the patient and for the physician (this part will be protected with a password during the duration of the trial). Physicians (prescribers or non-prescribers) in centres assigned to the intervention will be invited to be instructed on the materials (text, videos, checklists, calendars, etc).
Control will be standard care.
Each centre will recruit 15 consecutive adult patients with rheumatoid arthritis (as stated in the clinical records), less than 2 years since diagnosis and living independently.
The primary outcome will be therapeutic adherence (patient-level), defined as a score ≥ 80% in the Compliance Questionnaire on Rheumatology (CQR) and in the Adherence Medication Scale (RAM).
Secondary outcomes will be adherence to physical activity, a Mediterranean diet, lifestyle changes and disease activity.
Accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 79 patients per group are required, assuming that the initial proportion of adherent patients is 70% and at the end of the intervention, it would increase to 90% (only in the intervention group, in the control it would not change). A lost-to-follow-up rate of 25% has been estimated.
If 10 centres are selected to have at least 5 clusters for each group, this would correspond, rounding up, to 16 patients per centre, or a total of 160 patients.
The effect of the intervention on adherence to treatment will be refuted by the chi-square test and measured by relative risk (RR) and difference of proportions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster-trial
| Arm | Type | Receives |
|---|---|---|
| EducAR strategy | Active comparator | Behavioral: Multi-component interventionHealthcare personnel involved in the care of patients with RA in the selected centres will be provided with access to a website and instructed in its use in a videoconference. The website includes a training section for healthcare professionals and another for patients. The former includes explanatory videos on how to manage doctor-patient communication and to facilitate adherence and what not to do, tools to explain treatment options (shared decision aids) and links to key documents. The patient section includes information for patients (downloadable in leaflet format), medication calendars and disease diaries, videos explaining medication administration in RA and links to patient associations, among other tools. Both access to the website and its materials and to the instruction session will be open to all those involved in the corresponding service, but will not be mandatory. |
| Standard of care | No intervention | –Physicians in the control group will not be instructed and will have no access to the materials included in the physician section of the webpage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (>18 years of age)
- RA according to diagnosis recorded in clinical records
- < 2 years since diagnosis of rheumatoid arthritis.
- Independent daily living.
Key exclusion criteria (3 listed)
- Cognitive impairment
- Language barriers
- Impossibility of follow-up
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 |
|---|---|---|
| Multi-component interventionAlso: EducARWeb-based strategy with processes, materials, and patient and doctor education formats. | Behavioural | EducAR strategy |
Primary outcome
Number of patients with therapeutic adherence.
Time frame: 6 months
Score ≥ 80% both in the Compliance Questionnaire in Rheumatology (CQR) plus the in Adherence Medication Scale (RAM).
5 secondary outcomes
Adherence to physical exercise
Time frame: 6 months
Adherence to mediterranean diet
Time frame: 6 months
Disease activity
Time frame: 6 months
Degree of satisfaction with medical care
Time frame: 6 months
Health-related quality of life measured using the Short-form12 (SF-12) version 2 questionnaire, a shortened version of the SF-36
Time frame: 6 months
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 27 Nov 2023.
- Derived from this study: PubMed 40021204Ahijon Lana M, Sivera Mascaro F, Fernandez-Nebro A, Muntadas Castello S, Perez M, Oton T, Garcia de Yebenes MJ, Carmona L; EDUCAR Group. EducAR: implementing a multicomponent strategy to improve therapeutic adherence in rheumatoid arthritis. RMD Open. 2025 Feb 27;11(1):e004989. doi: 10.1136/rmdopen-2024-004989.
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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.
María Ahijon principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-component intervention in people with Rheumatoid Arthritis, run by María Ahijón at 15 sites in Spain.
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 4 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: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. 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?
Number of patients with therapeutic adherence. (time frame: 6 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 NCT05425485, which also lists 1 linked publication.
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 27 Nov 2023.