Self-management program for women with rheumatoid arthritis
Self-management Nursing Intervention for Women With Rheumatoid Arthritis: A Pragmatic Randomized Clinical Trial
This study tests a new self-management program for women with rheumatoid arthritis to see if it helps them feel more in control and improve their quality of life compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Universidad Nacional de Colombia Academic / other |
| Locations | 2 sites (Bogotá and 1 other locations) |
| Trial ID | NCT06337370 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a Chronic Disease Self-management Program (CDSMP) designed specifically for women with rheumatoid arthritis (RA). It employs a two-arm pragmatic randomized approach, comparing the self-management program to conventional care. The study aims to measure improvements in self-efficacy, self-management skills, and health-related quality of life among participants. By focusing on empowering women to manage their condition, the trial seeks to address the significant impact RA has on their daily lives and overall well-being.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 years old with a confirmed diagnosis of rheumatoid arthritis attending outpatient rheumatology consultations.
Not a fit: Patients with acute comorbid conditions or cognitive impairments that hinder their ability to participate in the program will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance the quality of life and self-management capabilities of women living with rheumatoid arthritis.
How similar studies have performed: Other studies have shown positive outcomes with self-management programs for chronic diseases, suggesting that this approach could be beneficial for women with rheumatoid arthritis as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women seen in outpatient control consultation by the rheumatology service at the Fundación Santa Fe de Bogotá; over 18 years of age with a confirmed diagnosis of RA according to the EULAR/ACR 2010. Exclusion Criteria: * Women with RA with a comorbid acute process (another or other chronic diseases that the person suffers from and at the time of being identified, are in the exacerbation or crisis phase). * Women with RA who present cognitive impairment that prevents them from participating in the program or answering the questionnaires due to cognitive impossibility to understand them.
Where this trial is running
Bogotá and 1 other locations
- Fundación Santa Fe de Bogotá — Bogotá, Colombia (Recruiting)
- Fundación Santa Fe — Bogotá, Colombia (Recruiting)
Study contacts
- Principal investigator: Vanessa Burbano, Master — Universidad Nacional de Colombia
- Study coordinator: Vanessa Burbano, Master
- Email: dvburbanor@unal.edu.co
- Phone: 3144676677
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.