educAR: Improving Adherence in Rheumatoid Arthritis (educAR)

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Behavioral: Multi-component intervention

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 Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Badalona, Spain
    • Hospital Universitari Germans Trias i Pujol
  • Córdoba, Spain
    • Hospital Universitario Reina Sofía
  • Elda, Spain
    • Hospital General Universitario de Elda
  • Igualada, Spain
    • Hospital Universitari d'Igualada
  • L'Hospitalet de Llobregat, Spain
    • Hospital Universitario de Bellvitge
  • Madrid, Spain, 28006
    • Hospital de La Princesa
  • Madrid, Spain
    • Hospital Universitario Ramón y Cajal
  • Murcia, Spain
    • Hospital Clínico Universitario Virgen de la Arrixaca
  • Málaga, Spain
    • Hospital General Universitario de Málaga
  • Pamplona, Spain
    • Hospital Universitario de Navarra
  • San Cristobal de La laguna, Spain
    • Hospital Universitario de Canarias
  • Santa Cruz De Tenerife, Spain
    • Hospital Universitario Nuestra Señora de la Candelaria
  • Sevilla, Spain
    • Hospital Universitario Virgen Macarena
  • Terrassa, Spain
    • Hospital Mútua de Terrassa
  • Valencia, Spain
    • Hospital Clinico Universitario de Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Multi-component intervention; Web-based strategy with processes, materials, and patient and doctor education formats.; Other Names: EducAR
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	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	6 months

Collaborators and Investigators

• Sponsor: María Ahijón
• Collaborators: Instituto de Salud Musculoesquelética SL
• Investigators: Principal Investigator: María Ahijon, Hospital La Princesa

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Patient education; Therapeutic adherence
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 4710

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No