Clinical trial NCT05425485: educAR: Improving Adherence in Rheumatoid Arthritis
Official title: educAR: Validation of a Double Educational Strategy to Improve Therapeutic Adherence in Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Therapeutic adherence
Patient education
Lead sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Musculoesquelética SL
First posted: 2022-06-21
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of patients with therapeutic adherence.
timeFrame: 6 months
Secondary outcomes:
measure: Adherence to physical exercise
timeFrame: 6 months
measure: Adherence to mediterranean diet
timeFrame: 6 months
measure: Disease activity
timeFrame: 6 months
measure: Degree of satisfaction with medical care
timeFrame: 6 months
measure: Health-related quality of life measured using the Short-form12 (SF-12) version 2 questionnaire, a shortened version of the SF-36
timeFrame: 6 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Elda
country: Spain
facility: Hospital General Universitario de Elda
city: Igualada
country: Spain
facility: Hospital Universitari d'Igualada
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital General Universitario de Málaga
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
city: San Cristobal de La laguna
country: Spain
facility: Hospital Universitario de Canarias
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de la Candelaria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: María Ahijon
role: PRINCIPAL_INVESTIGATOR
References: