EFFECTS OF A HEALTH SELF-MANAGEMENT STRATEGY PROTOCOL ON BIOPSYCHOSOCIAL ASPECTS OF INDIVIDUALS WITH RHEUMATOLOGICAL DISEASES: A SINGLE-BLINDED RANDOMIZED CONTROLLED CLINICAL TRIAL

• Grant number: 23/07043-9
• Support Opportunities: Scholarships in Brazil - Doctorate
• Start date: January 01, 2024
• Status: Discontinued
• Field of knowledge: Health Sciences - Physiotherapy and Occupational Therapy
• Principal Investigator: Paula Regina Mendes da Silva Serrão
• Grantee: Gabriel Bernardi dos Santos
• Host Institution: Centro de Ciências Biológicas e da Saúde (CCBS). Universidade Federal de São Carlos (UFSCAR). São Carlos , SP, Brazil
• Associated scholarship(s): 25/00339-5 - Health literacy and self-efficacy in Brazilian and Spanish populations with rheumatological diseases and respective differences, BE.EP.DR

Abstract

The present study proposes a self-management intervention in health in patients with rheumatological diseases, aiming to evaluate its effects on pain, physical function, fatigue, quality of life and sleep, psychosocial aspects and change in sedentary behavior of individuals with rheumatic diseases. This is a single-blinded randomized controlled clinical trial. Will be part of the study volunteers over 18 years old with diagnosis of rheumatological disease, randomly divided into 3 groups, which will receive intervention of 12 weeks of in-person treatment, twice a week, G1: physical exercise protocol (PEP); G2: PEP + educational booklet and G3: PEP + health self-management protocol. Outcomes will be evaluated using functional tests: 6-minute walk test, sit and stand, go up and down stairs, Time Up and Go; questionnaires: Pittsburgh Sleep Quality Index, Short-Form 36 Quality of Life, Fatigue Severity Scale, Hospital Anxiety and Depression Scale, Brief Symptom Inventory, the pain outcome will be evaluated through the Numerical Pain Scale and the volunteer will also perform the actigraphy test. The participant's health literacy will also be assessed using the 14-item Health Literacy Scale and the Newest Vital Sign. Follow-up will be performed at 3 and 6 months. For data analysis, the Statistical Package for Social Science version 19.0 program (SPSS Inc, Chicago, IL, USA) will be used. Initially, the data distribution, homoscedasticity and sphericity will be checked using the Shapiro-Wilk, Levene and Mauchly tests, respectively. If the data meet the normality requirements, the two-way ANOVA test will be applied, considering pain intensity as the dependent variable and groups (G1, G2 and G3) and time as independent variables, and the interaction between the group and time factors will be calculated. For all analyzes, a significance level of 5% (p d 0.05) will be adopted.