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

Primary Purpose

Oropharyngeal Dysphagia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Minimal-Massive Intervention
Sponsored by
Hospital de Mataró
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oropharyngeal Dysphagia focused on measuring Oropharyngeal Dysphagia, Aspiration pneumonia, Malnutrition, Oral Health, Bacterial colonization, Aging

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital de Mataró. Consorci Sanitari del Maresme.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Minimal-Massive Intervention

Arm Description

The minimal/basic intervention for a massive number of hospitalized patients.

Outcomes

Primary Outcome Measures

Reduction of incidence of respiratory infections due to the intervention.
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.

Secondary Outcome Measures

Improvement of signs and symptoms of oropharyngeal dysphagia
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.
Improvement of nutritional status of the patients enrolled.
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.
Improvement of oral health and hygiene of the patients enrolled.
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.
Improvement of quality of life of patients enrolled.
To evaluate the effects of the minimal-massive intervention in quality of life of patients enrolled measured with the EQ5D questionnaire.

Full Information

First Posted
June 25, 2014
Last Updated
April 30, 2019
Sponsor
Hospital de Mataró
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1. Study Identification

Unique Protocol Identification Number
NCT02396992
Brief Title
Minimal-Massive Intervention in Elderly Patients With Dysphagia
Acronym
MMI
Official Title
Evaluation of a Minimal-massive Intervention in Elderly Hospitalized Patients With Oropharyngeal Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Mataró

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
These study aims to evaluate the application of an assistance programme to: Perform a systematic screening of oropharyngeal dysphagia in older hospitalized patients (≥70 yr) admitted to internal medicine and geriatric unit of Hospital de Mataró. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Dysphagia
Keywords
Oropharyngeal Dysphagia, Aspiration pneumonia, Malnutrition, Oral Health, Bacterial colonization, Aging

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minimal-Massive Intervention
Arm Type
Other
Arm Description
The minimal/basic intervention for a massive number of hospitalized patients.
Intervention Type
Other
Intervention Name(s)
Minimal-Massive Intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Reduction of incidence of respiratory infections due to the intervention.
Description
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.
Time Frame
One year after discharge
Secondary Outcome Measure Information:
Title
Improvement of signs and symptoms of oropharyngeal dysphagia
Description
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.
Time Frame
One year after discharge
Title
Improvement of nutritional status of the patients enrolled.
Description
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.
Time Frame
One year after discharge
Title
Improvement of oral health and hygiene of the patients enrolled.
Description
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.
Time Frame
One year after discharge
Title
Improvement of quality of life of patients enrolled.
Description
To evaluate the effects of the minimal-massive intervention in quality of life of patients enrolled measured with the EQ5D questionnaire.
Time Frame
One year after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pere Clavé, PhD; MD
Organizational Affiliation
Hospital de Mataró
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Mataró. Consorci Sanitari del Maresme.
City
Mataró
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
29806864
Citation
Martin A, Ortega O, Roca M, Arus M, Clave P. Effect of A Minimal-Massive Intervention in Hospitalized Older Patients with Oropharyngeal Dysphagia: A Proof of Concept Study. J Nutr Health Aging. 2018;22(6):739-747. doi: 10.1007/s12603-018-1043-3.
Results Reference
derived

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Minimal-Massive Intervention in Elderly Patients With Dysphagia

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