Health Education to Caregivers to Reduce Aspiration Pneumonia

NCT05405829 | Completed

• 1 other identifier: INF-2018-08
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Oropharyngeal Dysphagia; Pneumonia; Malnutrition

Keywords

Elderly, Swallowing Disorders, pneumonia, caregivers

Outcome Measures

Primary Outcomes (10)

• Variable: pneumonia.

  Qualitative variable, dichotomous (yes/no). Pneumonia is defined according to the International Classification of Diseases of the lungs (ICD 11), often caused by infection by bacteria, viruses, fungi or parasites, although not always. It is characterized by fever, chills, productive cough, chest pain, and dyspnea" (WHO 2022). Measured through self-prepared questionnaire and Clinical History.

  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

• Variable: time of onset of pneumonia.

  Discrete quantitative variable. The elapsed time measured in months from the intervention to the appearance of the first pneumonia is considered.

  At 3 months after entering the study; At 12 months after entering the study.

• Variable: Admission for pneumonia in the last year.

  Qualitative, dichotomous variable (yes/no). Measured through own questionnaire.

  At 3 months after entering the study; At 12 months after entering the study.

• Variable: Number of admissions for pneumonia in the last year.

  Discrete numerical quantitative variable. Measured through the Clinic History and own questionnaire.

  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

• Variable: Malnutrition risk.

  Continuous quantitative variable. It is defined as "an unbalanced nutritional state resulting from insufficient nutrient intake to meet normal physiological requirements". Measured with Scale Mini Nutritional Assessment-Short Form (MNA-SF). Through the Clinic History and own questionnaire. Scale to assess malnutrition (maximum score of 14 points). 12-14 points: normal nutritional status; 8-11 points: risk of malnutrition; 0-7 points: malnutrition.

  At study entry; At 3 months after entering the study; At 12 months after entering the study

• Variable: Cognitive impairment.

  Discrete quantitative variable. Cognitive impairment is defined according to the Medical Subject Headings (MeSH) descriptor, as "the decrease or deterioration of mental and/or intellectual function". Measured with Pfeiffer test. Pfeiffer scale, It consists of 10 items. Between 0-2: it is considered normal; Between 3-4: mild cognitive impairment Between 5-7: moderate cognitive impairment; More than 8 errors: severe cognitive impairment.

  At study entry; At 3 months after entering the study; At 12 months after entering the study

• Variable: Risk of Bronchoaspiration.

  Discrete quantitative variable. It is defined as "A type of pulmonary inflammation resulting from the aspiration of food, liquid, or gastric contents into the upper respiratory tract." Measured with the volume-viscosity swallow test (V-VST). Test performed to detect if there is aspiration due to dysphagia. The signs are: cough, decrease in basal oxygen saturation greater than 5%, change in tone of voice and/or alteration in efficacy such as insufficient lip seal, oral or pharyngeal residuals and fractional swallowing. The test consists of three textures (water, nectar and pudding) with three volumes (5 ml, 10 ml and 20 ml). It begins by administering (5ml of nectar texture), if any sign is found that compromises safety, it will not go to a higher volume or lower viscosity. It is concluded that there is no dysphagia when there are no signs of safety or altered efficacy at any time of the test.

  Before entering the study.

• Variable: Dependence to perform activities of daily living.

  Ordinal quantitative variable. It is defined as the generic measure that assesses the patient's level of independence with respect to performing some basic activities of daily living. Measured by the Barthel Scale. It consists of 10 items, with different possible answers. Values from 0 points (total dependency) to 100 points (independent) \< 20 total dependency; 20-35 severe dependency; 40-55 Moderate dependency; ≥ 60 mild dependency; 100 independent

  At study entry; At 3 months after entering the study; At 12 months after entering the study

• Variable: Anxiety.

  Qualitative variable. It is defined by the Medical Subject Headings (MeSH) "as feelings or emotions of fear, apprehension and impending disaster but not disabling as with anxiety disorders". It is measured by the Goldberg scale (Assessment of the Anxiety subscale) It consists of 10 items, its assessment ranges from 0 (no problem) to 10 points (severe anxiety) The cut-off points are 4 or more for the anxiety subscale

  At study entry; At 3 months after entering the study; At 12 months after entering the study

• Variable: Burden.

  Qualitative variable. It is defined as "as the caregiver's subjective experience of care demands, it is a multidimensional concept, with objective and subjective characteristics. The objective burden corresponds to the changes that the caregiver must make in various areas of life and the subjective burden refers to the emotional reactions to the demands of care". It is measured by the Zarit scale (Assessment of caregiver burden) It consists of 22 items, with five possible answers. Maximum score of 88 points. A score below 46 is usually considered indicative of "no overload", and a score above 56 of "severe overload".

  At study entry; At 3 months after entering the study; At 12 months after entering the study

Secondary Outcomes (2)

• Variable: Level of Oropharyngeal Dysphagia.

  At study entry; At 3 months after entering the study; At 12 months after entering the study

• Variable: Diet adherence

  At 3 months after entering the study; At 12 months after entering the study

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

Other: Health education

Intervention group

EXPERIMENTAL

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.

Other: Health education

Interventions

Health education OTHER

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.

Control group; Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Parc Sanitari Pere Virgili

Barcelona, 08022, Spain

Location

Related Publications (3)

• 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.

  PMID: 26836016 RESULT

• 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.

  PMID: 32074560 RESULT

• 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.

  PMID: 29895512 RESULT

MeSH Terms

Conditions

Deglutition Disorders; Pneumonia; Malnutrition

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Alberto Gallart Fernández-Puebla, nursing

  Universitat Internacional de Catalunya

  STUDY DIRECTOR

• María Ángeles de Juan Pardo, nursing

  Universitat Internacional de Catalunya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: June 6, 2022
• Study Start: May 30, 2019
• Primary Completion: May 30, 2020
• Study Completion: March 28, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)