Effectiveness of an Optimal-Massive Intervention in Older Patients With Dysphagia

NCT04581486 | Unknown DMC

• 1 other identifier: OMI
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy of an optimal-massive intervention (OMI) based on increasing shear viscosity of fluids, nutritional support with oral nutritional supplements (ONS) and triple adaptation of food (rheological and textural, caloric and protein and organoleptic) and oral hygiene improvement on the incidence of respiratory infections in older patients with OD. We have designed a randomized clinical trial, with two parallel arms and 6 months follow-up. The study population will be constituted by older patients of 70 years or more with OD hospitalized at Hospital de Mataró by an acute process that will be identified by using the volume-viscosity swallow clinical test. We will consecutively recruit 500 subjects during admission (Geriatrics, Internal medicine, etc.) at the Hospital de Mataró. Patients included will be randomly assigned to one of both interventional groups: a) study intervention: multifactorial intervention based on fluid viscosity adaptation (with a xanthan gum thickener -\> Nutilis Clear®), nutritional support with a triple adaptation of food (texture, caloric and protein content, organoleptic) + pre-thickened ONS and evaluation and treatment of oral hygiene (tooth brushing + antiseptic mouthwashes + professional dental cleaning), or b) control intervention: standard clinical practice (fluid adaptation with Nutilis Powder and simple texture adaptation for solids). Main outcome measures: respiratory infection incidence during the 6-month period follow-up. Secondary outcomes: mortality at 6 months, general hospital readmissions and readmissions due to respiratory infections, nutritional status, hydration status, quality of life, functional status, oral hygiene and dysphagia severity and its relationship with other study variables.

Conditions

Swallowing Disorder; Oropharyngeal Dysphagia; Respiratory Infection; Malnutrition; Dehydration; Oral Disease

Outcome Measures

Primary Outcomes (1)

• Respiratory infections incidence.

  Respiratory infections incidence (includes LRTI, pneumonia and exacerbations of COPD): all new episodes of respiratory infections recorded in the clinical history or in the reports presented by the patient will be recorded. LRTI: presence of at least 2 of the following symptoms without other cause to explain them: fever, cough, purulent expectoration, rhonchi or wheezing. Pneumonia: performing 1 or more radiographic tests with new condensation, fever or leukopenia or leukocytosis and at least: cough, purulent expectoration, dyspnea, tachypnea, suggestive auscultation or worsening of gas exchange. COPD exacerbation: acute exacerbation of COPD is a sudden worsening of COPD symptoms (shortness of breath, quantity and color of phlegm) that typically lasts for several days. It may be triggered by an infection with bacteria or viruses or by environmental pollutants.

  From discharge to 6 months follow-up

Secondary Outcomes (11)

• Mortality

  Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.

• General readmissions and readmissions for respiratory infections

  Through study completion, at 1, 3 and 6 months from disharge.

• Nutritional status (MNA)

  Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.

• Nutritional status (Anthropometric measures)

  Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.

• Nutritional status (Anthropometric measures2)

  Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.

Other Outcomes (11)

• Sociodemographics

  Baseline

• Swallowing function (V-VST)

  Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.

• Institutionalization

  Through study completion, at 1, 3 and 6 months from disharge.

Study Arms (2)

OMI intervention

EXPERIMENTAL

Multimodal intervention based on optimal fluid viscosity adaptation (with Nutilis Clear®), optimal nutritional support with a triple adaptation of food (texture, (Nutilis Clear®)) caloric and protein content, organoleptic) + ONS depending on nutritional status and evaluation and optimal treatment of oral hygiene (tooth brushing + antiseptic mouthwash + professional dental cleaning)

Other: Optimal-Massive Intervention

Control intervention (standard clinical practice)

OTHER

Standard clinical practice (fluid adaptation with Nutilis Powder® and simple texture adaptation (for solids (Nutilis Powder®))

Other: Control (standard clinical practice)

Interventions

Optimal-Massive Intervention OTHER

Multimodal intervention based on 3 main measures: a) optimal fluid viscosity adaptation (with Nutilis Clear®), b) optimal nutritional support with a triple adaptation of food (texture, (Nutilis Clear®)) caloric and protein content, organoleptic) + ONS depending on nutritional status and evaluation and c) optimal treatment of oral hygiene (tooth brushing + antiseptic mouthwash + professional dental cleaning).

OMI intervention

Control (standard clinical practice) OTHER

Standard clinical practice (fluid adaptation with Nutilis Powder® and simple texture adaptation (for solids (Nutilis Powder®))

Control intervention (standard clinical practice)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients aged 70 years or older.
• Diagnosed oropharyngeal dysphagia (signs of impaired efficacy and/or safety of swallow assessed with the V-VST).
• Giving written informed consent. In case of dementia or incapacitation, given consent by the nearest relative, main caregiver or legal representative.

You may not qualify if:

• Impaired safety of swallow with 5mL at high viscosity (800 mPa•s for NC).
• Severe dementia (Pfeiffer \>6).
• Life expectancy less than 6 months.
• High functional dependence (Barthel index \<40, preadmission).
• Dysphagia caused by anatomical alterations or by head and neck cancer or its treatment.
• Patients going to nursing home or long-term care at discharge.
• Participation in any other studies involving investigational or marketed products within four weeks prior to start of the study.
• Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
• Patients with symptoms suggestive of COVID-19 or confirmed COVID-19.

Sponsors & Collaborators

• Hospital de Mataró: lead
• Nutricia Research: collaborator

Study Sites (1)

Consorci Sanitari del Maresme (Hospital de Mataró)

Mataró, Barcelona, 08301, Spain

RECRUITING

Related Publications (2)

• 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: 29806864 RESULT

• Ortega O, Martin A, Clave P. Diagnosis and Management of Oropharyngeal Dysphagia Among Older Persons, State of the Art. J Am Med Dir Assoc. 2017 Jul 1;18(7):576-582. doi: 10.1016/j.jamda.2017.02.015. Epub 2017 Apr 12.

  PMID: 28412164 RESULT

MeSH Terms

Conditions

Deglutition Disorders; Respiratory Tract Infections; Malnutrition; Dehydration; Mouth Diseases

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Infections; Respiratory Tract Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stomatognathic Diseases

Study Officials

• Pere Clavé, MD, PhD

  Director of Research and Academic Development at CSdM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pere Clavé, MD, PhD

CONTACT

+34937417700; pere.clave@ciberehd.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and Academic Development at CSdM

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 9, 2020
• Study Start: June 6, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

ES (1)