Clinical Validation of the Middle-Range Theory for the Nursing Diagnosis of Ineffective Health Self-Management.
Health Self-Management, Nursing Diagnosis, HIV Infections, Antiretroviral Therapy, Randomized Controlled Trials.
Health self-management is an essential component for therapeutic success and clinical control of People Living with the Human Immunodeficiency Virus (PLHIV). However, the presence of complex biopsychosocial factors often results in patterns of Ineffective Health Self- Management, which compromise optimal adherence to Antiretroviral Therapy (ART). In light of this issue, and the need to intervene based on solid theoretical evidence, this dissertation proposed the clinical validation of the Middle-Range Theory (MRT) for the nursing diagnosis of Ineffective Health Self-Management. The theoretical framework adopted was Callista Roy’s Adaptation Model, whose concepts were used to understand the adaptive challenges of this population. The main objective was to validate, both conceptually and clinically, the MRT. Methodology: The study was conducted in two distinct phases. The first phase consisted of a methodological study focused on the conceptual validation of the MRT by expert judges. The theory was evaluated by a panel of specialists using the theoretical analysis criteria proposed by Fawcett. The aim of this phase was to verify the clarity, consistency, and relevance of the theory’s concepts in the context of HIV infection. The second phase, clinical validation, was a double-blind Randomized Controlled Trial (RCT) conducted to test the effectiveness of a structured nursing intervention guided by the previously validated MRT. The intervention was designed to promote health self-management and was applied to a group of PLHIV, with the primary outcome being improved adherence to ART, compared with a control group. The study was approved by the ethics committee and is registered under number 90439725.0.0000.5537. Results: In the first phase, the evaluation by judges confirmed the conceptual validity of the MRT, attesting to its theoretical consistency and practical applicability in guiding nursing diagnostic reasoning and planning in the context of PLHIV. In the second phase, the findings of the RCT demonstrated that the nursing intervention guided by the MRT was effective. The intervention group showed a significant improvement in ART adherence compared with the control group, proving that the practical application of the theory leads to superior clinical outcomes in the management of chronicity. Conclusion: This dissertation concludes that the Middle-Range Theory for the nursing diagnosis of Ineffective Health Self- Management is validated both conceptually and clinically, establishing a robust theoretical-practical framework for Nursing. The study consolidates a scientific basis for structuring the nursing process in PLHIV, enabling the identification of the diagnosis and the implementation of interventions focused on Roy’s modes of adaptation, which result in measurable improvements such as increased ART adherence and optimization of clinical outcomes.