Rheumatoid ArthritisPE and RANCT07170371
Patient Education and Rheumatoid Arthritis
A study testing patient education in people with Rheumatoid Arthritis, run by Hassan II University at 1 site in Morocco.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteMorocco
- Study dates
- 5 Sep 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Education Program for Individuals With Rheumatoid Arthritis: A Randomized Controlled Trial
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
- Being tested
- patient education, Usual Care
- Keywords
- patient education
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient educationOther
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 CareOther
patients will receive usual care only
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: patient education |
| Usual care Group | Active comparator | patients will receive usual care only Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months after randomization
Secondary outcomes (4)
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
Measured: Baseline to 6 months after randomization
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.
Measured: Baseline to 6 months after randomization
MARS
Change in treatment adherence measured by the Medication Adherence Rating Scale (MARS), focusing on consistency of drug intake and attitudes toward treatment.
Measured: Baseline to 6 months after randomization
BDI
Change in depressive symptoms measured by the Beck Depression Inventory (BDI), and in perceived stress using standardized self-report tools
Measured: Baseline to 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start5 Sep 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hassan II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelaaziz Bounabe, Hassan II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170371
- Sponsor's protocol ID
- D/2025/HASSANII/54
- Acronym
- PE and RA
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Education Program for Individuals With Rheumatoid Arthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07170371
- Acronym / sponsor ID
- PE and RA / D/2025/HASSANII/54
- Conditions
- Rheumatoid Arthritis
- Keywords
- patient education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Hassan II UniversityUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patient education Group | Experimental | Other: patient educationA 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 Group | Active comparator | Other: Usual Carepatients will receive usual care only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient educationA 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 Group |
| Usual Carepatients will receive usual care only | Other | Usual care Group |
Primary outcome
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.
4 secondary outcomes
DAS-28
Time frame: Baseline to 6 months after randomization
ASES
Time frame: Baseline to 6 months after randomization
MARS
Time frame: Baseline to 6 months after randomization
BDI
Time frame: Baseline to 6 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient education in people with Rheumatoid Arthritis, run by Hassan II University at 1 site in Morocco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AIMS2 Quality of life (time frame: Baseline to 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.