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educAR: Improving Adherence in Rheumatoid Arthritis (educAR)

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multi-component intervention
Sponsored by
María Ahijón
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rheumatoid Arthritis focused on measuring Therapeutic adherence, Patient education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari Germans Trias i PujolRecruiting
  • Hospital Universitario Reina SofíaRecruiting
  • Hospital General Universitario de EldaRecruiting
  • Hospital Universitari d'IgualadaRecruiting
  • Hospital Universitario de BellvitgeRecruiting
  • Hospital de la PrincesaRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Clínico Universitario Virgen de la ArrixacaRecruiting
  • Hospital General Universitario de MálagaRecruiting
  • Hospital Universitario de NavarraRecruiting
  • Hospital Universitario de CanariasRecruiting
  • Hospital Universitario Nuestra Señora de la CandelariaRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting
  • Hospital Mutua de TerrassaRecruiting
  • Hospital Clínico Universitario de ValenciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

EducAR strategy

Standard of care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of patients with therapeutic adherence.
Score ≥ 80% both in the Compliance Questionnaire in Rheumatology (CQR) plus the in Adherence Medication Scale (RAM).

Secondary Outcome Measures

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.
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.
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).
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.
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

Full Information

First Posted
June 9, 2022
Last Updated
September 20, 2023
Sponsor
María Ahijón
Collaborators
Instituto de Salud Musculoesquelética SL
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1. Study Identification

Unique Protocol Identification Number
NCT05425485
Brief Title
educAR: Improving Adherence in Rheumatoid Arthritis
Acronym
educAR
Official Title
educAR: Validation of a Double Educational Strategy to Improve Therapeutic Adherence in Rheumatoid Arthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
María Ahijón
Collaborators
Instituto de Salud Musculoesquelética SL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Therapeutic adherence, Patient education

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster-trial
Masking
Participant
Masking Description
The patients are invited to participate in an observational study of adherence, as the intervention is done at the level of the care providers.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EducAR strategy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multi-component intervention
Other Intervention Name(s)
EducAR
Intervention Description
Web-based strategy with processes, materials, and patient and doctor education formats.
Primary Outcome Measure Information:
Title
Number of patients with therapeutic adherence.
Description
Score ≥ 80% both in the Compliance Questionnaire in Rheumatology (CQR) plus the in Adherence Medication Scale (RAM).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Adherence to physical exercise
Description
Measured using the Exercise Attitude Questionnaire-18 (EAQ-18). Final result is expressed out of 100 point. High scores indicate great adherence to exercise.
Time Frame
6 months
Title
Adherence to mediterranean diet
Description
Measured using the Mediterranean Diet Adherence Screener (MEDAS).Patients with a score <9 will be considered poor adherents to the Mediterranean diet.
Time Frame
6 months
Title
Disease activity
Description
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).
Time Frame
6 months
Title
Degree of satisfaction with medical care
Description
Measured using the Arthritis Satisfaction questionnaire. Final result is expressed in a range from 0 to 100 points. Higher scores indicate greater satisfaction.
Time Frame
6 months
Title
Health-related quality of life measured using the Short-form12 (SF-12) version 2 questionnaire, a shortened version of the SF-36
Description
Measured with the SF-12 version 2. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María Ahijon
Phone
+ 34 91 520 22 00
Email
maria.ahijon@salud.madrid.org
First Name & Middle Initial & Last Name or Official Title & Degree
Loreto Carmona
Phone
+34 628 578 576
Email
loreto.carmona@inmusc.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María Ahijon
Organizational Affiliation
Hospital La Princesa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Serrano
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Armenteros
Facility Name
Hospital General Universitario de Elda
City
Elda
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisca Sivera
Facility Name
Hospital Universitari d'Igualada
City
Igualada
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dolors Grados
Facility Name
Hospital Universitario de Bellvitge
City
L'Hospitalet de Llobregat
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lidia Valencia
Facility Name
Hospital de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Ahijón, PhD
Phone
+ 34 91 520 22 00
Email
maria.ahijon@salud.madrid.org
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia García
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
Murcia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Jose Moreno
Facility Name
Hospital General Universitario de Málaga
City
Málaga
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Cano
Facility Name
Hospital Universitario de Navarra
City
Pamplona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Idoya Piudo
Facility Name
Hospital Universitario de Canarias
City
San Cristobal de La laguna
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Isabel Rodríguez
Facility Name
Hospital Universitario Nuestra Señora de la Candelaria
City
Santa Cruz De Tenerife
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose María Martín
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Domínguez
Facility Name
Hospital Mutua de Terrassa
City
Terrassa
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inma Pérez
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel De La Morena

12. IPD Sharing Statement

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