NCT02396992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

June 25, 2014

Last Update Submit

April 30, 2019

Conditions

Oropharyngeal Dysphagia

Keywords

Oropharyngeal DysphagiaAspiration pneumoniaMalnutritionOral HealthBacterial colonizationAging

Outcome Measures

Primary Outcomes (1)

  • 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.

    One year after discharge

Secondary Outcomes (4)

  • Improvement of signs and symptoms of oropharyngeal dysphagia

    One year after discharge

  • Improvement of nutritional status of the patients enrolled.

    One year after discharge

  • Improvement of oral health and hygiene of the patients enrolled.

    One year after discharge

  • Improvement of quality of life of patients enrolled.

    One year after discharge

Study Arms (1)

Minimal-Massive Intervention

OTHER

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

Other: Minimal-Massive Intervention

Interventions

Minimal-Massive InterventionOTHER

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).

Minimal-Massive Intervention

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Mataró. Consorci Sanitari del Maresme.

Mataró, Barcelona, 08304, Spain

Location

Related Publications (1)

  • 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.

    PMID: 29806864DERIVED

MeSH Terms

Conditions

Deglutition DisordersPneumonia, AspirationMalnutrition

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesPneumoniaRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Pere Clavé, PhD; MD

    Hospital de Mataró

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. MD surgery.

Study Record Dates

First Submitted

June 25, 2014

First Posted

March 24, 2015

Study Start

March 1, 2014

Primary Completion

June 1, 2015

Study Completion

September 1, 2015

Last Updated

May 1, 2019

Record last verified: 2019-04

Locations

ES(1)