Minimal-Massive Intervention in Elderly Patients With Dysphagia (MMI)

April 30, 2019 updated by: Pere Clave, Hospital de Mataró

Evaluation of a Minimal-massive Intervention in Elderly Hospitalized Patients With Oropharyngeal Dysphagia

The purpose of this study is to apply a minimal-massive intervention (minimal recommendations to maximal number of patients) to elderly (>70 years) hospitalized patients with oropharyngeal dysphagia (OD). The intervention will consist of early screening and assessment of OD, malnutrition and oral hygiene. Patients will be given recommendations for adaptation of volume and viscosity of fluids, nutritional support and good oral hygiene practices and followed at 3, 6, 9 and 12 months after discharge. In every point of the follow-up period, patients will be re-evaluated to adjust recommendations and to verify their compliance with the treatment.

The objectives of the intervention are to have an impact on complications related to OD (avoid impaired safety alterations and improve nutritional and oral health status and reduce) and to reduce readmissions, readmissions for pneumonia and morbimortality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

These study aims to evaluate the application of an assistance programme to:

  1. Perform a systematic screening of oropharyngeal dysphagia in older hospitalized patients (≥70 yr) admitted to internal medicine and geriatric unit of Hospital de Mataró.
  2. Offer a minimal-massive treatment to older patients with OD based on, rheological adaptation of fluids (volume and viscosity), nutritional support based on traditional diet and oral hygiene treatment.
  3. To give education and knowledge about the diagnose and treatment of OD to the medical staff, caregivers and relatives of the patients to improve their management.

Study design:

Experimental pre-post interventional study with 1 year follow-up and 4 control points at 3, 6, 9 and 12 months after discharge. Pre-interventional evaluations will be done on admission and at discharge; post-interventional evaluations will be performed at 3, 6, 9 and 12 months after discharge. In every evaluation point the investigators will obtain data about OD (efficacy and safety of swallow with the Volume-Viscosity Swallowing Test (V-VST)), health status of the patients (comorbidities, functionality, frailty, anthropometric measurements, illnesses and medication), nutritional status (MNA-sf and Bioimpedance), oral hygiene (dental evaluation with the Simplified Oral Hygiene Index (OHI-S)) and respiratory infections and pneumonia rates. In addition during the follow-up period the investigators will collect readmissions incidence (all readmissions, respiratory infections and pneumonia), institutionalization and death. Data collected will be compared with the previous year of the same patient and with a historical control group of untreated older patients with OD that will be matched for age, sex, comorbidities and functionality.

The intervention will consist on adaptation of fluids (volume and viscosity) in accordance with V-VST results, nutritional supplementation with traditional food (based on MNA-sf and bioimpedance results) and recommendation of good oral hygiene practices (based on dental evaluation). In every point of the follow-up period, recommendations will be given to patients.

Objectives:

  • The primary objective is to launch and evaluate the effect of the minimal-massive program in hospitalized older patients with OD.
  • To evaluate the effect of the intervention on the signs and symptoms of OD, nutritional status, oral hygiene, functional status and quality of life of patients included at the program at 3, 6, 9 and 12 months after discharge.
  • To describe readmission rates for any reason, readmission rates for pneumonia, institutionalization rate and mortality rate in the study population compared to an historical control group of older patients with OD and no intervention.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Mataró, Barcelona, Spain, 08304
        • Hospital de Mataró. Consorci Sanitari del Maresme.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

68 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Older patients (≥70 years) admitted to Unit 5 and 8 of Hospital de Mataró.
  • With OD diagnosed by the V-VST.
  • Patients that have signed the informed consent form.
  • Patients without any exclusion criteria.

Exclusion Criteria:

  • Patients not able to comply with the protocol.
  • Patients currently participating in any clinical trial or during the 4 last weeks.
  • Patients with severe dementia or inability to communicate (GDS ≥ 6).
  • Patients of the Intensive Care Unit.
  • Patients with low functionality (Barthel pre-admission ≤ 40).
  • Patients with high mortality risk (Walter score > 6).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Minimal-Massive Intervention
The minimal/basic intervention for a massive number of hospitalized patients.
Other: Minimal-Massive Intervention
The intervention will consist in basic recommendations based on the evaluations done at admission and discharge: a) diet adaptation (solids and fluids) based on dysphagia clinical evaluation (V-VST) to avoid efficacy or safety alterations; b) nutritional supplements in case of malnutrition (MNA-sf; bioimpedance and blood analysis) to improve nutritional status;and c) oral health and hygiene recommendations (toothbrushing and antiseptic mouthwashes to decline bacterial colonization).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of incidence of respiratory infections due to the intervention.
Time Frame: One year after discharge
Readmissions for respiratory infections (including pneumonia) will be recorded and compared with the previous year of the same patient (pre-post study) and with a retrospective control group of elderly patients with dysphagia without intervention. Review of the medical history of the patient will be done by a medical doctor. Follow-up visits will be done every three months for a total of 12 months.
One year after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of signs and symptoms of oropharyngeal dysphagia
Time Frame: One year after discharge
To evaluate the effects of the minimal-massive intervention above signs and symptoms of oropharyngeal dysphagia due to the use of thickener. Follow-up visits will be done every three months for a total of 12 months.
One year after discharge
Improvement of nutritional status of the patients enrolled.
Time Frame: One year after discharge
To evaluate the effects of the minimal-massive intervention above nutritional status of the patient measured with the MNA-sf, bioimpedance and blood analytical parameters. Follow-up visits will be done every three months for a total of 12 months.
One year after discharge
Improvement of oral health and hygiene of the patients enrolled.
Time Frame: One year after discharge
To evaluate the effects of the minimal-massive intervention above oral hygiene status of the patients measured with the OHI-S and a dental examination including periodontal disease and caries. Follow-up visits will be done every three months for a total of 12 months.
One year after discharge
Improvement of quality of life of patients enrolled.
Time Frame: One year after discharge
To evaluate the effects of the minimal-massive intervention in quality of life of patients enrolled measured with the EQ5D questionnaire.
One year after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Mataró

Investigators

  • Principal Investigator: Pere Clavé, PhD; MD, Hospital de Mataró

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Actual)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMM2013-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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