educAR: Improving Adherence in Rheumatoid Arthritis

NCT05425485 | Completed

• 1 other identifier: 4710
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 15

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.

Conditions

Rheumatoid Arthritis

Keywords

Therapeutic adherence; Patient education

Outcome Measures

Primary Outcomes (1)

• Number of patients with therapeutic adherence.

  Score ≥ 80% both in the Compliance Questionnaire in Rheumatology (CQR) plus the in Adherence Medication Scale (RAM).

  6 months

Secondary Outcomes (5)

• Adherence to physical exercise

  6 months

• Adherence to mediterranean diet

  6 months

• Disease activity

  6 months

• Degree of satisfaction with medical care

  6 months

• Health-related quality of life measured using the Short-form12 (SF-12) version 2 questionnaire, a shortened version of the SF-36

  6 months

Study Arms (2)

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.

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.

Interventions

Multi-component intervention BEHAVIORAL

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

Also known as: EducAR

EducAR strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• María Ahijón: lead
• Instituto de Salud Musculoesquelética SL: collaborator

Study Sites (15)

Hospital Universitari Germans Trias i Pujol

Badalona, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Hospital General Universitario de Elda

Elda, Spain

Location

Hospital Universitari d'Igualada

Igualada, Spain

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Spain

Location

Hospital de la Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital General Universitario de Málaga

Málaga, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Universitario de Navarra

Pamplona, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Spain

Location

Hospital Universitario Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

Hospital Mutua de Terrassa

Terrassa, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Spain

Location

Related Publications (1)

• 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.

  PMID: 40021204 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Health Behavior; Behavior

Study Officials

• María Ahijon

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients are invited to participate in an observational study of adherence, as the intervention is done at the level of the care providers.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Cluster-trial

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 21, 2022
• Study Start: October 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Locations

ES (15)