Health Education to Caregivers to Reduce Aspiration Pneumonia (HECGPN)

Universitat Internacional de Catalunya

Status: Completed

Conditions: Malnutrition; Oropharyngeal Dysphagia; Pneumonia

Treatments: Other: Health education

Study type: Interventional

Funder types: Other

Identifiers

NCT05405829

INF-2018-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 178 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient inclusion criteria:

• People over 65 years of age, with cognitive impairment, evaluated with the Pfeiffer Test ≥ 3. With risk of bronchoaspiration, detected by the presence of oropharyngeal dysphagia and confirmed with the test (V-VST). Risk of malnutrition, evaluated with the MNA-SF test ≤ 11 and with dependency to perform the basic activities of daily living, with a Barthel index ≤ 61.
• Voluntary participation and signing the informed consent after being informed orally and in writing about the study, the patient or responsible relative.

Caregiver inclusion criteria:

• Voluntary participation and signing the informed consent after being informed orally and in writing about the study.

Patient exclusion criteria:

• Patients with a high degree of oropharyngeal dysphagia (that is, when they bronchoaspirate when administering 5 ml of pudding texture while performing the test (V-VST) to measure oropharyngeal dysphagia).
• Patients with delirium at the time of evaluation.
• Institutionalized patients, in residences or long stay.

Caregiver exclusion criteria:

• That the caregiver is not the usual one. This means that, at the time of the study, the patient is not cared for by the usual reference person. Therefore, the caregiver is present in a punctual and transitory situation.
• That patients or their caregivers do not understand the Catalan or Spanish language.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 2 patient groups

Control group

Active Comparator group

Description:

Conventional information received by caregivers. The speech therapist comes to the room to pass the Volume viscosity exploratory method test (V-VST) Test and after confirming dysphagia, informs the patient of the test result and delivers a booklet of recommendations.

Treatment:

Other: Health education

Intervention group

Experimental group

Description:

A 45-minute session, 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.

Treatment:

Other: Health education