Clinical trial NCT06337370: Self-management Nursing Intervention for Women With Rheumatoid Arthritis
Official title: Self-management Nursing Intervention for Women With Rheumatoid Arthritis: A Pragmatic Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthritis, Rheumatoid
Keywords: Chronic disease self management program
Women
Arthrits rheumatoid
Health related quality of life
Selfmanagement
Self efficacy
Pragmatic randomized controlled trial
Lead sponsor: Universidad Nacional de Colombia
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Statement of the problem Inflammatory rheumatic diseases, as chronic degenerative diseases, represent a high expense for the General Social Security Health System (SGSSS) reflected in the costs of care and the affectation in the personal, labor, social and family spheres that cause a deterioration in the quality of life related to the health of the individual.

The main representative of this group is RA, considered as a chronic and disabling systemic disease affecting joints, connective tissue, muscles, tendons and fibrous tissue. By causing pain and deformity, it is one of the main causes of absenteeism and premature retirement from work in the world.

However, the general age of onset is in adulthood. In the interval between 55 and 59 years of age, about 50% of people suffering from this condition, after 10 years, have lost their ability to work or are unable to maintain a full-time job.

Looking at Colombia, figures reveal that 2.2% of the general population suffers from RA. Specifically, for the year 2022, a total of 118,497 cases were reported, of which 5,115 were incidents with a percentage increase of 41.53 % compared to the previous period and, of these, 81.52 % are women, with a female-to-male ratio of 4.41 to 1. Regarding the situation observed in Bogotá, the High-Cost Account (CAC) states that this is one of the regions with the highest number of cases reported by the territorial entities: 28,012 for the year 2022.

Because of the personal, physical, occupational, family and social impact it produces on the health and well-being of the affected population, RA is classified as a ruinous, catastrophic, progressive, high-cost disease of public health interest. Specifically, its presence in the female population represents a source of low levels of health-related quality of life (HRQoL).

In this sense, Corbin and Strauss, regarding the impact of chronic disease on patients' lives, state that their experience requires the fulfillment of three types of tasks: management of the disease seen as the clinical management of the condition, management of the role in terms of behavioral management and management of the emotions associated with the new experience. In the case of women with RA, the Pan American League of Rheumatology Associations (PANLAR) and the Latin American Group for the Study of RA (GLADAR) highlight the implementation of interventions aimed at improving self-management as one of the priorities for health care in Latin America.

According to Grady and Gough, self-management is a highly effective strategy to address chronic diseases because it offers people, in addition to information, the necessary tools to detect and solve the problems associated with their disease.

Lorig \& Holman state that, because RA is a chronic condition that accompanies and modifies the patient's life from the moment of diagnosis, it requires participation focused on resolving the difficulties that the disease brings with it, managing resources and making informed decisions that allow him/her to adopt or restructure behaviors to live fully.

Currently, nursing interventions are available that have addressed self-management in chronic conditions such as RA, aimed at developing in the person the ability to self-manage their health reflected in self-management behaviors; however, the available evidence on their effect in Latin American countries has not been evaluated and the cost for their implementation and validation is very high.

In this sense, although in Latin America there are no specific self-management programs for the care of people with RA, there is a generic self-management program for chronic diseases -Chronic Disease Self Management Program- called in Spanish "Tomando el control de su salud", validated in some states of Mexico, by Peñarrieta and his research group at the Autonomous University of Tamaulipas with support from the Pan American Health Organization.

Both the specific self-management program for RA and the generic self-management program for chronic diseases were designed at Stanford University and when comparing them, the authors describe that both programs show positive results in health, that although the specific program can show advantages 4 months after the post-intervention measurement, these advantages are reduced after one year, concluding that the CDSMP program is a viable alternative when resources are not sufficient and suggesting that with the implementation of a generic program it is possible to reach a greater number of people at a lower cost, a similar situation occurred in the case of the CDSMP program, a similar situation occurred in the study by Goeppinger who, when comparing the effect of both programs in the African American population with RA, found statistically significant differences in pain and disability for both groups 4 months after implementation; in this case, the CDSMP showed better results.

The evaluation of the effect of the CDSMP program in Latin countries has only been measured in Tampico, Mexico, by Peñarrieta, who through a two-arm experimental approach: intervention group and control group applied it to patients with chronic diseases attended in first level care institutions, in their results they describe that the program is effective in improving health and self-management behaviors in adults with diabetes and arterial hypertension in Tampico, however, they highlight the need to continue conducting research to understand the effect of the self-management program in NCDs in the different regions of Mexico and the rest of Latin America, they suggest using objective measures with a longer follow-up; they state as limitations: a small sample size and the measurement of dependent and independent variables with self-report scales, increasing the possibility of bias.

To understand the mechanisms involved in the adoption of self-management behaviors, it is essential to take into account psychosocial aspects such as self-efficacy, i.e., the belief in each person's ability to organize and execute the courses of action necessary to produce certain achievements. The CDSMP program is based on Bandura's theory of self-efficacy, which identifies it as a determining factor for the adoption of health behaviors and decision making.

Thus, recognizing the negative impact and burden of rheumatoid arthritis on the health and well-being of women and the great contribution that the nursing discipline can offer through its intervention, the present research proposal is proposed as a novel approach that aims to evaluate the effect of a self-management intervention - CDSMP - for women with RA in Bogota.

Study Justification The nursing intervention in self-management for women with RA finds its justification in the chronic condition of the disease that implies that people play an active role in the control of their symptoms, in the anticipation of complications and in the possibility of being managers of health behaviors in benefit of their health-related quality of life. For such reason, there is a growing need to evidence the effect of nursing interventions in self-management on chronic disabling conditions, such as RA in Latin America.

This research, therefore, proposes an innovation in nursing care for the health of women with RA, which corresponds to the integration of a self-management intervention with empirical support and the consideration of psychosocial variables such as self-efficacy and health-related quality of life. This is intended to help reduce the disarticulation that exists between the welfare approach and the Primary Health Care (PHC) approach, which transcends the consideration of people's particularities. Likewise, the self-management and self-efficacy behaviors that could generate benefits in health-related quality of life will be known in greater depth.

Research Question Is the self-management intervention - CDSMP - effective in increasing levels of self-efficacy, self-management behaviors and health-related quality of life (HRQOL) of women with RA seen in outpatient care at a health institution in Bogota compared to conventional care?

General Objective To evaluate the effect of the self-management intervention -CDSMP- on self-efficacy, self-management behaviors and health-related quality of life of women with RA attended in outpatient consultation at a health institution in Bogotá, compared to conventional care.

Specific Objectives. To describe the clinical and sociodemographic variables present in women with RA participating in the study.

To compare the levels of self-efficacy, self-management behaviors, and health-related quality of life of women with RA who received the intervention -CDSMP- before and after its application.

To compare the levels of self-efficacy, self-management and health-related quality of life of women with RA included in the experimental group with the levels of self-efficacy, self-management and health-related quality of life of women with RA in the control group.

Hypothesis

The nursing intervention in self-management CDSMP - is effective in increasing the levels of self-efficacy of women with RA attended in outpatient consultation at a health institution in Bogota compared to conventional care.

The nursing intervention in self-management CDSMP-, is effective in increasing self-management behaviors of women with RA attended in outpatient consultation in a health institution in Bogota compared to conventional care.

The nursing intervention in self-management CDSMP - is effective in increasing the levels of health-related quality of life of women with RA attended in outpatient consultation at a health institution in Bogota compared to conventional care.

Eligibility 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.

Primary outcomes:
measure: Self-management behaviors
timeFrame: 8 weeks
Secondary outcomes:
measure: Perceived Self-efficacy,
timeFrame: 8 weeks
measure: Health-related quality of life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Fundación Santa Fe de Bogotá
city: Bogotá
country: Colombia
facility: Fundación Santa Fe
Study officials:
affiliation: Universidad Nacional de Colombia
name: Vanessa Burbano, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Nacional de Colombia
name: Olga Gómez Ramírez, PhD
role: STUDY_DIRECTOR
affiliation: Fundación Santa Fe de Bogotá
name: Gerardo Quintana López, Master
role: STUDY_DIRECTOR
affiliation: Fundación Santa Fe de Bogotá
name: Wilson Bautista Molano, PhD
role: STUDY_CHAIR
affiliation: Fundación Santa Fe de Bogotá
name: Paul Alejandro Méndez Patarroyo, Esp
role: STUDY_CHAIR
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