NCT06337370Completed
Self-management Nursing Intervention for Women With Rheumatoid Arthritis
Self-management Nursing Intervention for Women With Rheumatoid Arthritis: A Pragmatic Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 10 Sept 2025
Brief summary (registry, in English)
Introduction. Chronic autoimmune diseases are catalogued as catastrophic conditions that generate a negative impact on the health and well-being of the affected person. In this particular case, rheumatoid arthritis (RA) is its main representative, which is a predominant disease in women, affecting not only the musculoskeletal system but in general, all dimensions of the human being and generating great costs for health systems. Adaptation to living with the disease requires the individual to develop capacities for a positive management of the condition, and in this sense, the development of self-management behaviors becomes a crucial element. Method. The investigators propose a two-arm pragmatic randomized clinical trial with pre- and post-intervention measures, to evaluate the effect of the Chronic Disease Selfmanagement Program (CDSMP) on the increase in the levels of self-efficacy, self-management and health-related quality of life of women with RA who are attended by outpatient rheumatology consultation in a health institution in Bogota compared to usual care. Results. A description will be made of the sociodemographic and clinical variables present in you together with the measurement of the variables of health-related quality of life through the Quality Of Life-Rheumatoid Arthritis Scale-II (QOLRA-II); self-efficacy with the specific scale of self-efficacy in arthritis; and self-management behaviors by means of the scale of self-management in the disease. The measurement for the intervention group will be performed before and after the implementation of the program and for the control group an initial measurement and another one after six weeks. Discussion. The implementation of the CDSMP could generate a positive effect on the variables of self-management, self-efficacy and health-related quality of life in women with RA who are attended by outpatient consultation in a health institution in Bogota compared to usual care.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 27 Feb 2024
- Start date
- Jun 2024
- Primary completion date
- Aug 2025
- Lead sponsor
- Universidad Nacional de Colombia
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06337370
What you commit to
- Study type: Interventional
- Participants enrolled: 44
- From Jun 2024 to the primary completion date, Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- This study examined women over the age of 18 who were treated at rheumatology outpatient clinics at a health center in Bogotá and had a confirmed diagnosis of rheumatoid arthritis according to the 2010 EULAR/ACR classification criteria.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundación para la Investigación en Dermatología y Reumatología- Funinderma Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.