Self-management Nursing Intervention for Women With Rheumatoid Arthritis

NCT06337370 | Completed

• 1 other identifier: 61284
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic disease self management program; Women; Arthrits rheumatoid; Health related quality of life; Selfmanagement; Self efficacy; Pragmatic randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Self-management behaviors

  For self-management, participants are expected to achieve a high overall score on the self-management behaviors scale, with scores above 80 points. The scale consists of 12 items with three dimensions: adherence to treatment (7 items 3, 4, 5, 6, 7, 8 and 12); symptom management (3 items 9, 10 and 11) and knowledge (2 items 1 and 2). The answers to the 12 items of the instrument are structured on a scale of 0 to 8 points, the sum of the scores obtained in each item presents the global self-management, the higher the score, the higher the global self-management (0 to 96 points). To identify the specific score for each dimension, the sum of the items corresponding to each dimension (knowledge: maximum score 16 points; adherence: 56 points; and symptom management: 24 points) is added together.

  8 weeks

Secondary Outcomes (2)

• Perceived Self-efficacy,

  8 weeks

• Health-related quality of life

  8 weeks

Study Arms (2)

CDSMP Group

EXPERIMENTAL

Participants will receive the chronic disease selfmanagement program for 6 weeks.

Behavioral: Chronic Disease Self Management Program

Conventional Care Group

ACTIVE COMPARATOR

Participants will receive conventional care.

Behavioral: Conventional Intervention- Standard care

Interventions

Chronic Disease Self Management Program BEHAVIORAL

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.

CDSMP Group

Conventional Intervention- Standard care BEHAVIORAL

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.

Conventional Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead
• Ministerio de Ciencia Tecnología e Innovación - Minciencias: collaborator

Study Sites (1)

Fundación para la Investigación en Dermatología y Reumatología- Funinderma

Bogotá, Bogota D.C., 111311, Colombia

Location

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Vanessa Burbano, Master

  Universidad Nacional de Colombia

  PRINCIPAL INVESTIGATOR

• Olga Gómez Ramírez, PhD

  Universidad Nacional de Colombia

  STUDY DIRECTOR

• Gerardo Quintana López, Magíster en Epidemiología Clín

  Fundación Santa Fe de Bogotá

  STUDY CHAIR

• Ruben Dario Mantilla Hernández, Especialista en Reumatología

  Fundación para la Investigación en Dermatología y Reumatología- Funinderma

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: In order to guarantee the objectivity and impartiality of the research team, randomization will be accompanied by blinding. A single-blind trial is proposed in which the participants during the conduct of the study will be unaware of their assignment to the experimental or control groups; likewise, the research assistants who perform the pre and post measurement will be unaware of their assignment to the groups; there will be specific assistants for the pre measurement and specific assistants for the post measurement with each group. Candidates will be invited to participate in the study, explaining to them that it is a randomized study in which they may be assigned to a specific intervention group, that their assignment will only be random, that neither the research team nor the treating health team will be able to interfere with their assignment and that this will be revealed to them once the study is completed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: CDSMP is a group-based chronic disease self-management education intervention comprised of 2.5-hour sessions, including time for a break and snack. The maximum number of participants per session ranges from 12 to 16. In total the program consists of 6 sessions that take place once a week for a total duration of 6 weeks. The development of each of the sessions is standardized and scripted; two group leaders previously trained by a Master Trainer, who in turn was trained to train leaders with Stanford University, guide the sessions. In the case of the present study, the main researcher and a nursing professional with experience in health education will receive the training from a Master Trainer of the program. Participants receive the book "Taking Control of Your Health" at the beginning of the program.

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 29, 2024
• Study Start: June 6, 2024
• Primary Completion: August 10, 2025
• Study Completion: August 10, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)