Rheumatoid Arthritis (RA)NCT07761767
Self-Care Education for Joint Stiffness and Functional Ability in Rheumatoid Arthritis
A study testing self care educational program for the study group and Routine care in people with Rheumatoid Arthritis (RA), run by Assiut University.
Trial summary
Rheumatoid arthritis is a chronic inflammatory autoimmune disease that may cause joint stiffness, pain, reduced mobility, and impaired functional ability. Self-care education may help patients improve their knowledge and practices related to disease management, joint protection, physical activity, exercise, energy… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- self care educational program for the study group and Routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The criteria for selection were: patients" age ranged between 20-65 years old; did not have any auditory, visual or psychological problems. Patients who are able to communicate and participate in the educational program.
- Patients who agree to participate in the study.
Who cannot join
- Patients with severe cognitive or communication impairment. Patients with other severe musculoskeletal conditions that may affect functional ability.
- Patients who have participated in a similar self-care educational program recently.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of a Self-Care Educational Program on Joint Stiffness and Functional Ability in Patients With Rheumatoid Arthritis
Rheumatoid arthritis is a chronic inflammatory autoimmune disease that may cause joint stiffness, pain, reduced mobility, and impaired functional ability. Self-care education may help patients improve their knowledge and practices related to disease management, joint protection, physical activity, exercise, energy conservation, and symptom management.
This study aims to evaluate the effectiveness of a self-care educational program on joint stiffness and functional ability among patients with rheumatoid arthritis. Participants will be assigned to either a study group or a control group. The study group will receive the self-care educational program in addition to routine care, while the control group will receive routine care only. Joint stiffness and functional ability will be assessed before and after implementation of the educational program.
Read the detailed description
Rheumatoid arthritis is associated with joint inflammation, stiffness, pain, reduced physical functioning, and limitations in activities of daily living. Appropriate self-care practices may contribute to improving patients' ability to manage symptoms and maintain functional independence.
The self-care educational program will provide patients with information and practical guidance regarding rheumatoid arthritis and its management. The program may include disease-related knowledge, medication adherence, joint protection techniques, exercise, energy conservation, activity modification, symptom management, and appropriate self-care practices.
Participants will be divided into two groups:
Study Group: Participants will receive the self-care educational program in addition to routine care.
Control Group: Participants will receive routine care only. Joint stiffness and functional ability will be assessed at baseline and after implementation of the educational program. The outcomes of the study group will be compared with those of the control group to determine the effectiveness of the program.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- self care educational program for the study group, Routine care
- Keywords
- Rheumatoid Arthritis, Self-Care, Joint Stiffness, Functional Ability
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self care educational program for the study groupBehavioural
study group Participants will receive the self-care educational program in addition to usual care.
Routine careOther
The control group will receive the routine care provided to patients with rheumatoid arthritis and will not receive the self-care educational program during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Self-Care Education Group | Experimental | Participants in the intervention group will receive a self-care educational program designed to improve self-care practices, reduce joint stiffness, and improve functional ability in patients with rheumatoid arthritis. The program will include education about rheumatoid arthritis, joint protection techniques, appropriate exercises, medication use, and self-care practices. Receives: Behavioral: self care educational program for the study group |
| Routine Care Group | Other | Participants will receive usual care without the self-care educational program. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in joint stiffness
Duration of morning joint stiffness will be assessed using a single-item patient-reported outcome measure. Participants will report the duration of their morning joint stiffness in minutes. Durations greater than 12 hours (720 minutes) will be recorded as 720 minutes. Higher values indicate a longer duration of morning joint stiffness.
Severity of morning joint stiffness will be assessed using a single-item patient-reported outcome measure. Participants will rate the overall severity of their morning joint stiffness on a numerical rating scale ranging from 0 to 10, where 0 indicates no joint stiffness and 10 indicates the worst possible joint stiffness. Higher scores indicate greater severity of joint stiffness.
Measured: Baseline and 3 months after completion of the intervention.
Secondary outcomes (1)
functional ability
Functional ability will be assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI). The HAQ-DI assesses functional ability across eight areas: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored from 0 (without any difficulty) to 3 (unable to do). The overall score ranges from 0 to 3, with 0 indicating no disability and 3 indicating severe disability. Higher scores indicate worse functional ability and greater disability.
Measured: Baseline and 3 months after completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 assigned to two parallel groups: an intervention group receiving the self-care educational program and a control group receiving usual care.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rezk Abdallah Mohammed Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761767
- Sponsor's protocol ID
- 1120261455
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to make individual participant data available to other researchers.
Publications
Seyam, M. H., Boghdady, E. S. G., Abo El-Ata, A. B., & Mahdy, N. E. S. (2024). Knowledge, Practices and Self-Care Management Behaviors for Rheumatoid Arthritis Patients. Port Said Scientific Journal of Nursing, 11(3), 48-68.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Self-Care Educational Program on Joint Stiffness and Functional Ability in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07761767
- Acronym / sponsor ID
- 1120261455
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid Arthritis, Self-Care, Joint Stiffness, Functional Ability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 12 Aug 2026 (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.
Rheumatoid arthritis is a chronic inflammatory autoimmune disease that may cause joint stiffness, pain, reduced mobility, and impaired functional ability. Self-care education may help patients improve their knowledge and practices related to disease management, joint protection, physical activity, exercise, energy conservation, and symptom management.
This study aims to evaluate the effectiveness of a self-care educational program on joint stiffness and functional ability among patients with rheumatoid arthritis. Participants will be assigned to either a study group or a control group. The study group will receive the self-care educational program in addition to routine care, while the control group will receive routine care only. Joint stiffness and functional ability will be assessed before and after implementation of the educational program.
Detailed description
Rheumatoid arthritis is associated with joint inflammation, stiffness, pain, reduced physical functioning, and limitations in activities of daily living. Appropriate self-care practices may contribute to improving patients' ability to manage symptoms and maintain functional independence.
The self-care educational program will provide patients with information and practical guidance regarding rheumatoid arthritis and its management. The program may include disease-related knowledge, medication adherence, joint protection techniques, exercise, energy conservation, activity modification, symptom management, and appropriate self-care practices.
Participants will be divided into two groups:
Study Group: Participants will receive the self-care educational program in addition to routine care.
Control Group: Participants will receive routine care only. Joint stiffness and functional ability will be assessed at baseline and after implementation of the educational program. The outcomes of the study group will be compared with those of the control group to determine the effectiveness of the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to two parallel groups: an intervention group receiving the self-care educational program and a control group receiving usual care.
| Arm | Type | Receives |
|---|---|---|
| Self-Care Education Group | Experimental | Behavioral: self care educational program for the study groupParticipants in the intervention group will receive a self-care educational program designed to improve self-care practices, reduce joint stiffness, and improve functional ability in patients with rheumatoid arthritis. The program will include education about rheumatoid arthritis, joint protection techniques, appropriate exercises, medication use, and self-care practices. |
| Routine Care Group | Other | Other: Routine careParticipants will receive usual care without the self-care educational program. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The criteria for selection were: patients" age ranged between 20-65 years old; did not have any auditory, visual or psychological problems. Patients who are able to communicate and participate in the educational program.
- Patients who agree to participate in the study.
Key exclusion criteria (2 listed)
- Patients with severe cognitive or communication impairment. Patients with other severe musculoskeletal conditions that may affect functional ability.
- Patients who have participated in a similar self-care educational program recently.
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 |
|---|---|---|
| self care educational program for the study groupstudy group Participants will receive the self-care educational program in addition to usual care. | Behavioural | Self-Care Education Group |
| Routine careThe control group will receive the routine care provided to patients with rheumatoid arthritis and will not receive the self-care educational program during the study period. | Other | Routine Care Group |
Primary outcome
change in joint stiffness
Time frame: Baseline and 3 months after completion of the intervention.
Duration of morning joint stiffness will be assessed using a single-item patient-reported outcome measure. Participants will report the duration of their morning joint stiffness in minutes. Durations greater than 12 hours (720 minutes) will be recorded as 720 minutes. Higher values indicate a longer duration of morning joint stiffness. Severity of morning joint stiffness will be assessed using a single-item patient-reported outcome measure. Participants will rate the overall severity of their morning joint stiffness on a numerical rating scale ranging from 0 to 10, where 0 indicates no joint stiffness and 10 indicates the worst possible joint stiffness. Higher scores indicate greater severity of joint stiffness.
1 secondary outcome
functional ability
Time frame: Baseline and 3 months after completion of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Results publicationSeyam, M. H., Boghdady, E. S. G., Abo El-Ata, A. B., & Mahdy, N. E. S. (2024). Knowledge, Practices and Self-Care Management Behaviors for Rheumatoid Arthritis Patients. Port Said Scientific Journal of Nursing, 11(3), 48-68.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. There are no plans to make individual participant data available to other researchers.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing self care educational program for the study group and Routine care in people with Rheumatoid Arthritis (RA), run by Assiut University.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact REZK A Mohammed, MSc (1122883312 20+, RizkAbdullah@nursing.aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in joint stiffness (time frame: Baseline and 3 months after completion of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07761767, which also lists 1 linked publication.
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 13 Aug 2026.