- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07761767
Self-Care Education for Joint Stiffness and Functional Ability in Rheumatoid Arthritis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: REZK A Mohammed, MSc
- Phone Number: 1122883312 20+
- Email: RizkAbdullah@nursing.aswu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-Care Education Group
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.
|
study group Participants will receive the self-care educational program in addition to usual care.
|
|
Other: Routine Care Group
Participants will receive usual care without the self-care educational program.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline and 3 months after completion of the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
functional ability
Time Frame: Baseline and 3 months after completion of the intervention.
|
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.
|
Baseline and 3 months after completion of the intervention.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1120261455
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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