Status:

COMPLETED

Health Education to Caregivers to Reduce Aspiration Pneumonia

Lead Sponsor:

Universitat Internacional de Catalunya

Conditions:

Oropharyngeal Dysphagia

Pneumonia

Eligibility:

All Genders

65+ years

Phase:

NA

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 aspiratio...

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 techn...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    May 30 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 28 2023

    Estimated Enrollment :

    178 Patients enrolled

    Trial Details

    Trial ID

    NCT05405829

    Start Date

    May 30 2019

    End Date

    March 28 2023

    Last Update

    March 29 2023

    Active Locations (1)

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    1

    Parc Sanitari Pere Virgili

    Barcelona, Spain, 08022