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Active, not recruitingNCT07170371PE and RAUpdated Sep 12, 2025

Patient Education and Rheumatoid Arthritis

An interventional study of patient education and Usual Care in Rheumatoid Arthritis, sponsored by Hassan II University. Active, not recruiting at 1 site in Morocco. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by Hassan II University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • patient education
03

In context

Arthritis, Rheumatoid

3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.

This study's planned enrollment of 88 is close to the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Hassan II University is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of other systemic 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
88 participants (estimated)

Study arms

  • Experimental
    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.

    Other: patient education

  • Active comparator
    Usual care Group

    patients will receive usual care only

    Other: Usual Care

Interventions

  • Otherpatient education

    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.

  • OtherUsual Care

    patients will receive usual care only

06

What researchers measure

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.

    Time frame: Baseline to 6 months after randomization

Secondary outcomes

  1. DAS-28

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

    Time frame: Baseline to 6 months after randomization

  2. ASES

    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.

    Time frame: Baseline to 6 months after randomization

  3. MARS

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

    Time frame: Baseline to 6 months after randomization

  4. BDI

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

    Time frame: Baseline to 6 months after randomization

07

Study locations

1 site
  • university hospital IBN ROCHD
    Casablanca, Morocco
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Sep 2025, 0 months after the start.

Of 292 non-industry interventional studies with no phase under Arthritis, Rheumatoid, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's planned 0 months is below that.

Counting every sponsor, half of 348 studies reached it within 27 months; a quarter within 13 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2025
First posted
Sep 12, 2025
StartActual
Sep 5, 2025
Primary completionEst.
Sep 30, 2025
CompletionEst.
Mar 30, 2026
Last update
Sep 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07170371
Lead sponsor
Hassan II University
Responsible party
Abdelaaziz Bounabe (Dr BOUNABE ABDELAAZI, Hassan II University) — Principal investigator
First posted
Sep 12, 2025
Start date
Sep 5, 2025
Primary completion
Sep 30, 2025 (estimated)
Completion
Mar 30, 2026 (estimated)
Last update
Sep 12, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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