Patient Education and Rheumatoid Arthritis

NCT07170371 | Active Not Recruiting DMC

• 1 other identifier: D/2025/HASSANII/54
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis

Keywords

patient education

Outcome Measures

Primary Outcomes (1)

• AIMS2 Quality of life

  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.

  Baseline to 6 months after randomization

Secondary Outcomes (4)

• 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

Study Arms (2)

Patient education Group

EXPERIMENTAL

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.

Other: patient education

Usual care Group

ACTIVE COMPARATOR

patients will receive usual care only

Other: Usual Care

Interventions

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.

Patient education Group

Usual Care OTHER

patients will receive usual care only

Usual care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hassan II University: lead

Study Sites (1)

university hospital IBN ROCHD

Casablanca, Morocco

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr BOUNABE ABDELAAZI

Model Details: Participants will be randomized into two parallel groups. One group will receive a culturally adapted patient education program in addition to usual medical care, while the other group will receive usual care alone. The two groups will be followed for 6 months, with comparative evaluation of outcomes related to self-management and quality of life.

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: September 5, 2025
• Primary Completion: September 30, 2025
• Study Completion: March 30, 2026
• Last Updated: September 12, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)