Patient Education Program for Individuals With Rheumatoid Arthritis: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- AIMS2 Quality of life
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patient education Group
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.
Intervention: patient education (Other)
Usual care Group
patients will receive usual care only
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
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
- DAS-28(Baseline to 6 months after randomization)
- ASES(Baseline to 6 months after randomization)
- MARS(Baseline to 6 months after randomization)
- BDI(Baseline to 6 months after randomization)
Investigators
Abdelaaziz Bounabe
Dr BOUNABE ABDELAAZI
Hassan II University