Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04581486
Recruitment Status : Not yet recruiting
First Posted : October 9, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
Nutricia Research
Information provided by (Responsible Party):
Pere Clave, Hospital de Mataró

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.

Condition or disease Intervention/treatment Phase
Swallowing Disorder Oropharyngeal Dysphagia Respiratory Infection Malnutrition Dehydration Oral Disease Other: Optimal-Massive Intervention Other: Control (standard clinical practice) Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the Effectiveness of an Optimal-Massive Intervention in Older Patients With Oropharyngeal Dysphagia
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OMI intervention
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
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).

Control intervention (standard clinical practice)
Standard clinical practice (fluid adaptation with Nutilis Powder® and simple texture adaptation (for solids (Nutilis Powder®))
Other: Control (standard clinical practice)
Standard clinical practice (fluid adaptation with Nutilis Powder® and simple texture adaptation (for solids (Nutilis Powder®))




Primary Outcome Measures :
  1. Respiratory infections incidence. [ Time Frame: From discharge to 6 months follow-up ]
    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.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge. ]
    Mortality: the date and reason for death will be recorded (hospitalization, 1, 3 and 6 months).

  2. General readmissions and readmissions for respiratory infections [ Time Frame: Through study completion, at 1, 3 and 6 months from disharge. ]
    General readmissions and readmissions for respiratory infections (1, 3 and 6 months): LRTI, pneumonia and exacerbations of COPD: the reason for admission will be that stated in the hospital database (CMBDAH) according to CIM-10. The information source of the readmissions will be the registration of hospital discharges that is integrated into the hospital information system and that includes the CIM-10 codes of the main and secondary diagnoses of the episode that caused the admission, the date of admission and discharge and the days of hospitalization. Readmissions from pneumonia (codes CIM-10): J13, J18.1, J15.1, J14, J15.4, J15.211, J15.5, A48.1, J15.8, J18.0, J18.8, J69.0; readmissions for LRTI (no pneumonic): J20.0 - J20.9, J10.1, J11.1, J41.8, J44.1 and J44.0. Readmissions from exacerbation of COPD: J441.

  3. Nutritional status (MNA) [ Time Frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge. ]
    Mini-nutritional assessment form (MNA) (hospitalization, 1, 3 and 6 months).

  4. Nutritional status (Anthropometric measures) [ Time Frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge. ]
    Heigh in cm (hospitalization, 1, 3 and 6 months).

  5. Nutritional status (Anthropometric measures2) [ Time Frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge. ]
    Weight in kg (hospitalization, 1, 3 and 6 months).

  6. Nutritional status (Biochemical parameters) [ Time Frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge. ]
    Biochemical parameters from blood analysis (hospitalization, 3 and 6 months).

  7. Hydration status (bioimpedance) [ Time Frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge. ]
    Hydration status: we will register total body water and intracellular water with bioimpedance (hospitalization, 1, 3 and 6 months).

  8. Quality of life of patients during the study period [ Time Frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge. ]
    Quality of life: EQ-5D questionnaire will be used (hospitalization, 1, 3 and 6 months).

  9. Functional status [ Time Frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge. ]
    Functional status: we will use the Barthel Index (hospitalization, 1, 3 and 6 months).

  10. Oral Hygiene [ Time Frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge. ]
    Oral Hygiene: the OHI-S (simplified oroal hygiene index) will be collected (hospitalization, 1, 3 and 6 months).

  11. Dysphagia severity [ Time Frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge. ]
    Severity of dysphagia: according to the different viscosities that patients will be able to swallow and with the Functional Oral Intake Scale (V-VST/FOIS) (hospitalization, 1, 3 and 6 months).


Other Outcome Measures:
  1. Sociodemographics [ Time Frame: Baseline ]
    Sociodemographic characteristics of the study population.

  2. Swallowing function (V-VST) [ Time Frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge. ]
    Swallowing function (V-VST) (hospitalization, 1, 3 and 6 months).

  3. Institutionalization [ Time Frame: Through study completion, at 1, 3 and 6 months from disharge. ]
    Rate of institutionalization (1, 3 and 6 months).

  4. Pharmacological treatment [ Time Frame: Baseline ]
    Drugs taken by the patient.

  5. Geriatric syndromes [ Time Frame: Baseline ]
    Geriatric syndromes

  6. Frailty 1 [ Time Frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge. ]
    Fried criteria (hospitalization, 1, 3 and 6 months).

  7. Frailty 2 [ Time Frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge. ]
    Edmonton frail scale (hospitalization, 1, 3 and 6 months).

  8. Toxic habits [ Time Frame: Baseline ]
    Smoking and alcohol consumption

  9. Compliance [ Time Frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge. ]
    Compliance with the recommendations of the study intervention (adaptations of fluid, prescribed diets and oral hygiene) (hospitalization, 1, 3 and 6 months).

  10. Palatability [ Time Frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge. ]
    Palatability of the intervention products will be measured with the 5-point facial hedonic scale (hospitalization, 1, 3 and 6 months).

  11. Acceptability [ Time Frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge. ]
    Acceptability of the dietes will be measured with the Food Action Rating Scale (hospitalization, 1, 3 and 6 months)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04581486


Contacts
Layout table for location contacts
Contact: Pere Clavé, MD, PhD +34937417700 ext 1046 pere.clave@ciberehd.org

Locations
Layout table for location information
Spain
Consorci Sanitari del Maresme (Hospital de Mataró)
Mataró, Barcelona, Spain, 08301
Sponsors and Collaborators
Hospital de Mataró
Nutricia Research
Investigators
Layout table for investigator information
Principal Investigator: Pere Clavé, MD, PhD Director of Research and Academic Development at CSdM
Publications of Results:
Layout table for additonal information
Responsible Party: Pere Clave, Director of Research and Academic Development at CSdM, Hospital de Mataró
ClinicalTrials.gov Identifier: NCT04581486    
Other Study ID Numbers: OMI
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Tract Infections
Deglutition Disorders
Mouth Diseases
Malnutrition
Dehydration
Nutrition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Infection
Respiratory Tract Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes
Stomatognathic Diseases