Clinical trial NCT05405829: Health Education to Caregivers to Reduce Aspiration Pneumonia
Official title: Educational Intervention for Caregivers of the Elderly With Cognitive Impairment and Risk of Bronchial Aspiration, to Reduce Episodes of Pneumonia. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oropharyngeal Dysphagia
Pneumonia
Malnutrition
Keywords: Elderly, Swallowing Disorders, pneumonia, caregivers
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 178
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Variable: pneumonia.
timeFrame: At 12 months before entering the study; At 3 months before entering the study; At 3 months after entering the study; At 12 months after entering the study
measure: Variable: time of onset of pneumonia.
timeFrame: At 3 months after entering the study; At 12 months after entering the study.
measure: Variable: Admission for pneumonia in the last year.
timeFrame: At 3 months after entering the study; At 12 months after entering the study.
measure: Variable: Number of admissions for pneumonia in the last year.
timeFrame: At 12 months before entering the study; At 3 months before entering the study; At 3 months after entering the study; At 12 months after entering the study
measure: Variable: Malnutrition risk.
timeFrame: At study entry; At 3 months after entering the study; At 12 months after entering the study
measure: Variable: Cognitive impairment.
timeFrame: At study entry; At 3 months after entering the study; At 12 months after entering the study
measure: Variable: Risk of Bronchoaspiration.
timeFrame: Before entering the study.
measure: Variable: Dependence to perform activities of daily living.
timeFrame: At study entry; At 3 months after entering the study; At 12 months after entering the study
measure: Variable: Anxiety.
timeFrame: At study entry; At 3 months after entering the study; At 12 months after entering the study
measure: Variable: Burden.
timeFrame: At study entry; At 3 months after entering the study; At 12 months after entering the study
Secondary outcomes:
measure: Variable: Level of Oropharyngeal Dysphagia.
timeFrame: At study entry; At 3 months after entering the study; At 12 months after entering the study
measure: Variable: Diet adherence
timeFrame: At 3 months after entering the study; At 12 months after entering the study
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Parc Sanitari Pere Virgili
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Alberto Gallart Fernández-Puebla, nursing
role: STUDY_DIRECTOR
affiliation: Universitat Internacional de Catalunya
name: María Ángeles de Juan Pardo, nursing
role: STUDY_DIRECTOR
References:
citation: Boccardi V, Ruggiero C, Patriti A, Marano L. Diagnostic Assessment and Management of Dysphagia in Patients with Alzheimer's Disease. J Alzheimers Dis. 2016;50(4):947-55. doi: 10.3233/JAD-150931.
citation: Nakamura K. [Aspiration pneumonia in elderly stroke patients in a convalescent rehabilitation ward: Risk factors and effects on recovery after stroke]. Nihon Ronen Igakkai Zasshi. 2020;57(1):45-52. doi: 10.3143/geriatrics.57.45. Japanese.
citation: Hopwood J, Walker N, McDonagh L, Rait G, Walters K, Iliffe S, Ross J, Davies N. Internet-Based Interventions Aimed at Supporting Family Caregivers of People With Dementia: Systematic Review. J Med Internet Res. 2018 Jun 12;20(6):e216. doi: 10.2196/jmir.9548.