Self-management Nursing Intervention for Women With Rheumatoid Arthritis

Summary

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.

Conditions

• Arthritis, Rheumatoid

Interventions

BEHAVIORAL

Chronic Disease Self Management Program

Experimental Intervention (Self-Management Program): In addition to standard care from a rheumatology specialist, the intervention group will receive the Chronic Disease Self-Management Program (CDSMP). This program is a group intervention that provides education on self-managing chronic diseases. The program consists of six weekly sessions, each lasting two and a half hours (including time for breaks and refreshments), for a total of six weeks. Each group will consist of 12 to 16 participants, and the sessions will follow a standardized, scripted format. Two group leaders, who have received training from a Master Trainer certified by Stanford University in how to implement the program, will lead the activities. For this study, the principal investigator and a nurse experienced in health education will undergo training from a CDSMP Master Trainer to ensure fidelity to the intervention.

BEHAVIORAL

Conventional Intervention- Standard care

Conventional intervention (standard care): The control group will receive standard care provided by a rheumatology specialist. This approach emphasizes clinical and clinimetric evaluations of rheumatoid arthritis. It includes applying validated disease activity indices (e.g., DAS28, CDAI, or SDAI), making therapeutic decisions, and adjusting medications according to current clinical practice guidelines. It also includes the standard clinical counseling provided during routine medical consultations. No additional self-management strategies or structured interventions beyond those already incorporated into routine healthcare practice will be included.

Sponsors & Collaborators

• Ministerio de Ciencia Tecnología e Innovación - Minciencias

  collaborator UNKNOWN

• Universidad Nacional de Colombia

  lead OTHER

Principal Investigators

• Vanessa Burbano, Master · Universidad Nacional de Colombia

• Olga Gómez Ramírez, PhD · Universidad Nacional de Colombia

• Gerardo Quintana López, Magíster en Epidemiología Clín · Fundación Santa Fe de Bogotá

• Ruben Dario Mantilla Hernández, Especialista en Reumatología · Fundación para la Investigación en Dermatología y Reumatología- Funinderma

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-06

Primary Completion

2025-08-10

Completion

2025-08-10

Countries

• Colombia

Study Locations