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Active, Not Recruiting

NCT Number: NCT07170371

Patient Education and Rheumatoid Arthritis

The goal of this clinical trial is to learn if a culturally adapted patient education program can help people with rheumatoid arthritis (RA) manage their disease and improve their quality of life. The main questions it aims to answer are:

* Does the program improve patients' knowledge, self-management skills, and confidence in dealing with RA? * Does it lead to better quality of life and treatment adherence compared to usual care?

Participants will:

* Join group sessions and individual activities focused on RA education, self-care, and stress management * Take part in the program for 6 months, with regular follow-up visits * Complete questionnaires about symptoms, daily activities, and quality of life

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

university hospital IBN ROCHD

Casablanca, Morocco

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (≥18 years) diagnosed with rheumatoid arthritis according to ACR/EULAR 2010 classification criteria
  • Stable pharmacological treatment for at least 3 months prior to enrollment
  • Ability to participate in group sessions and complete questionnaires
  • Provided written informed consent

Exclusion criteria

  • Diagnosis of other systemic autoimmune or inflammatory rheumatic diseases (e.g., lupus, psoriatic arthritis)
  • Severe comorbidities that may interfere with participation (e.g., advanced heart failure, uncontrolled psychiatric illness)
  • Cognitive impairment or language barrier preventing comprehension of the program
  • Participation in another structured patient education program within the last 6 months

Treatment and study plan

Patient Education

Other

A culturally adapted patient education program designed for individuals with rheumatoid arthritis. The program was developed through a structured needs assessment and based on established health behavior theories. It includes five core modules delivered over six months: understanding rheumatoid arthritis, monitoring disease activity, treatment strategies, nutrition, and stress management. Sessions combine group workshops and individual support, with interactive materials and practical exercises. The program aims to strengthen patients' knowledge, self-management skills, and quality of life compared to usual care.

Usual Care

Other

patients will receive usual care only

Primary outcomes

  1. AIMS2 Quality of life

    Time frame: Baseline to 6 months after randomization

    Change in health-related quality of life among participants, measured using validated patient-reported questionnaires (AIMS2) to assess physical, emotional, and social domains. The focus is on improvement in self-reported well-being and daily functioning.

Secondary outcomes

  1. DAS-28

    Time frame: Baseline to 6 months after randomization

    Change in disease activity, assessed by the Disease Activity Score 28 (DAS28), including tender/swollen joint counts, ESR/CRP levels, and patient global assessment

  2. ASES

    Time frame: Baseline to 6 months after randomization

    Change in patient self-efficacy for managing rheumatoid arthritis, assessed with the Arthritis Self-Efficacy Scale (ASES), covering pain, function, and other disease-related aspects.

  3. MARS

    Time frame: Baseline to 6 months after randomization

    Change in treatment adherence measured by the Medication Adherence Rating Scale (MARS), focusing on consistency of drug intake and attitudes toward treatment.

  4. BDI

    Time frame: Baseline to 6 months after randomization

    Change in depressive symptoms measured by the Beck Depression Inventory (BDI), and in perceived stress using standardized self-report tools

Sponsors and collaborators

Lead sponsor

Hassan II University

Other

Registry information

Official study title

Patient Education Program for Individuals With Rheumatoid Arthritis: A Randomized Controlled Trial

Acronym: PE and RA

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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