NCT05405829

Health Education to Caregivers to Reduce Aspiration Pneumonia

Educational Intervention for Caregivers of the Elderly With Cognitive Impairment and Risk of Bronchial Aspiration, to Reduce Episodes of Pneumonia. A Randomized Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Universitat Internacional de Catalunya · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Randomized clinical study with a control group for assessing the decrease in the incidence of pneumonia, in a 12-month follow-up, in older people with cognitive impairment, risk of bronchial aspiration, risk of malnutrition and dependence to perform basic activities of daily living, through the design and implementation of an educational program. to the caregivers of these patients.

Detailed description

Introduction: The number of people over 65 years of age is increasing, observing an older population worldwide. In the year 2050 there will be 2,000 million, this situation is due to medical and technological advances, in addition to the declining birth rate. People live longer, but there is also a higher incidence of chronic diseases, associated with age. Among them, neurodegenerative diseases stand out, due to the dependence they entail, as well as the risk of situations such as episodes of bronchial aspiration, which can cause pneumonia that will require hospital admissions, as well as the risk of malnutrition and dependence to carry out basic activities of daily life. . Most of these patients are cared for at home by their caregivers, who, in addition to not knowing how to care for oropharyngeal dysphagia, the situation of prolonged fatigue can generate overload and anxiety for the caregiver. Objective: To evaluate the decrease in the incidence of pneumonia, in a 12-month follow-up, in older adults with cognitive impairment, risk of bronchial aspiration, risk of malnutrition and dependence to carry out basic activities of daily living, through the design and implementation of a educational program. to the caregivers of these patients. Methodology: A sequential exploratory mixed study will be carried out. For the design of the educational intervention, a descriptive qualitative study will be carried out with focus groups of caregivers and the recommendations of the Health Literacy model will be followed. To evaluate the efficacy of this intervention, a pre-post intervention randomized clinical trial with a control group will be carried out. The sample will be 178 couples made up of caregivers (formal or informal non-professional caregivers) and people over 65 who are in their care. The study will be carried out at the Parc Sanitari Per Virgili in Barcelona from May 2019 to March 2023. The main variables and study instruments are the incidence and admissions for pneumonia, as well as its delay in onset in older people, measured by Clinical history, cognitive impairment, measured with the Pfeiffer test, the risk of bronchial aspiration measured with the volumetric viscosity exploratory method test (V-VST), the risk of malnutrition measured with the Mini Nutritional Assessment short-form scale (MNA- SF). In addition to the anxiety and overload of their caregivers, measured with the Goldberg and Zarit scale.

Conditions

• Oropharyngeal Dysphagia
• Pneumonia
• Malnutrition

Interventions

Type	Name	Description
OTHER	Health education	theoretical-practical hygienic-dietary training, with visual support and work materials where three specific interventions are explained: textures for solids and liquids, safety postures to reduce the risk of bronchial aspiration, and oral hygiene. In addition, tools are offered to caregivers so that they can identify situations of anxiety and overload, as well as guidelines for social support.

Timeline

• Start date: 2019-05-30
• Primary completion: 2020-05-30
• Completion: 2023-03-28
• First posted: 2022-06-06
• Last updated: 2023-03-29

Locations

1 site across 1 country: Spain