educAR: Improving Adherence in Rheumatoid Arthritis

NCT ID: NCT05425485

Last Updated: 2023-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-10-31

Brief 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 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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

EducAR strategy

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.

Group Type: ACTIVE_COMPARATOR

Multi-component intervention

Intervention Type: BEHAVIORAL

Web-based strategy with processes, materials, and patient and doctor education formats.

Standard of care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multi-component intervention

Web-based strategy with processes, materials, and patient and doctor education formats.

Intervention Type: BEHAVIORAL

Other Intervention Names

EducAR

Eligibility Criteria

Inclusion Criteria

• Adults (>18 years of age)
• RA according to diagnosis recorded in clinical records
• < 2 years since diagnosis of rheumatoid arthritis.
• Independent daily living.

Exclusion Criteria

• Cognitive impairment
• Language barriers
• Impossibility of follow-up

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Musculoesquelética SL

UNKNOWN

Sponsor Role: collaborator

María Ahijón

OTHER

Sponsor Role: lead

Responsible Party

María Ahijón

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

María Ahijon

Role: PRINCIPAL_INVESTIGATOR

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Locations

Hospital Universitari Germans Trias i Pujol

Badalona, , Spain

Hospital Universitario Reina Sofía

Córdoba, , Spain

Hospital General Universitario de Elda

Elda, , Spain

Hospital Universitari d'Igualada

Igualada, , Spain

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, , Spain

Hospital de la Princesa

Madrid, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital General Universitario de Málaga

Málaga, , Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, , Spain

Hospital Universitario de Navarra

Pamplona, , Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, , Spain

Hospital Universitario Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Hospital Mutua de Terrassa

Terrassa, , Spain

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 40021204 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

4710

Identifier Type: -

Identifier Source: org_study_id