Swallowing DisorderOMINCT04581486
Effectiveness of an Optimal-Massive Intervention in Older Patients With Dysphagia
A study testing Optimal-Massive Intervention in people with Swallowing Disorder and Oropharyngeal Dysphagia, run by Hospital de Mataró at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Swallowing Disorder, Oropharyngeal Dysphagia, Respiratory Infection
- What is being tested?
- Optimal-Massive Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 6 Jun 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Consorci Sanitari del Maresme (Hospital de Mataró)
Mataró, Barcelona, 08301
Pere Clavé, MD, PhD, +34937417700 ext. 1046, pere.clave@ciberehd.org
Omar Ortega, MSc, PhD
About this study
Official title: Evaluation of the Effectiveness of an Optimal-Massive Intervention in Older Patients With Oropharyngeal Dysphagia
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.
Read the detailed description
DESIGN
- Study design: Randomized controlled clinical trial with two parallel arms and 6 months follow-up.
AIMS
- Primary aim: To evaluate the effect of a rheological, nutritional and oral hygiene intervention (OMI) on the incidence of respiratory infections including lower respiratory tract infections -LRTI-, pneumonia and chronic obstructive pulmonary disease (COPD) infectious exacerbations in older patients with OD at 6 months follow-up.
- Secondary aims: to evaluate the effect at 1, 3 and 6 months of this intervention on:
- Mortality.
- General hospital readmission and hospital readmission due to respiratory infections.
- Nutritional status according to the MNA, anthropometrical measures and biochemical markers.
- Hydration status according to bioimpedance.
- Quality of life according to the EQ-5D.
- Functional status according to Barthel index.
- Oral hygiene status according to the simplified oral hygiene index (OHI-S).
Other aims:
- To evaluate the effect at 1, 3 and 6 months of this intervention on:
- Swallowing function according to the V-VST.
- Rate of institutionalization.
- Compliance with the treatments (thickeners, ONS, diets and oral health).
- Palatability and acceptability of diets.
- To evaluate the relationship between severity of dysphagia (V-VST / FOIS), nutritional status, oral hygiene and the incidence of respiratory infections (LRTI, pneumonia and/or COPD exacerbations). STUDY POPULATION
- Study subjects: 500 older patients with OD admitted to Hospital de Mataró for acute conditions (internal medicine, cardiology, pneumology, neurology, geriatric wards, etc). Number of subjects necessary: 500 (G1: 250; G2: 250): Accepting an α risk of 0.05 and a β risk of 0.2 in a bilateral contrast, 244 subjects in each group are required to detect as statistically significant difference in the percentage of patients with LRTI at six months that for the control group is expected to be 20 % and for the intervention group of 10% (reduction by half).A tracking loss rate of 20% has been assumed and the required number of subjects (244) in each group already includes the dropout rate. Investigators will intend to recruit a total sample of 500* individuals, 250 in each intervention branch. SAFETY - Safety and tolerance parameters: Incidence, frequency, seriousness, severity and relatedness of adverse events or serious adverse events. STUDY GROUPS AND INTERVENTION
- Study groups: there will be 2 groups of patients: G1 - study intervention, 250 patients; G2 - control intervention, 250 patients.
- Study interventions:there will be 2 interventions: G1) study 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); G2) control intervention: standard clinical practice (fluid adaptation with Nutilis Powder® and simple texture adaptation (for solids (Nutilis Powder®)). STATISTICAL ANALYSIS
- Statistical analysis: the primary outcome will be the occurrence of the respiratory infections during the follow-up period (number of events/100 patients-year) and will be mainly analyzed with the Poisson regression. Qualitative data will be presented as relative and absolute frequencies and analyzed by the Fisher's exact test or the Chi-square test. Volume and viscosity levels (V-VST) will be compared between them by applying the McNemar's test. Continuous data will be presented as mean±standard deviation (SD) and compared with the T-test (intergroup comparisons) or Paired T-test (intragroup comparisons). For those variables that will not follow a normal distribution, the nonparametric Mann-Whitney U-test (intergroup comparisons), the Wilcoxon-paired test (intragroup comparisons) or the Kruskal-Wallis' test for multiple comparisons with Dunn's multiple comparison test will be used. Survival curves will be used to evaluate 6-month mortality after discharge. The primary analysis will be performed on the ITT population. Note: primary analysis is on number of events at 6 months follow-up, to simplify sample size considerations are based on percentage of patients with LRTI at 6 months.
- Conditions
- Swallowing Disorder, Oropharyngeal Dysphagia, Respiratory Infection, Malnutrition, Dehydration, Oral Disease
- Being tested
- Optimal-Massive Intervention, Control (standard clinical practice)
- Medical subject headings
- Deglutition Disorders, Respiratory Tract Infections, Malnutrition, Dehydration, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal-Massive InterventionOther
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 (standard clinical practice)Other
Standard clinical practice (fluid adaptation with Nutilis Powder® and simple texture adaptation (for solids (Nutilis Powder®))
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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®)) Receives: Other: Control (standard clinical practice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From discharge to 6 months follow-up
Secondary outcomes (11)
Mortality
Mortality: the date and reason for death will be recorded (hospitalization, 1, 3 and 6 months).
Measured: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
General readmissions and readmissions for respiratory infections
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.
Measured: Through study completion, at 1, 3 and 6 months from disharge.
Nutritional status (MNA)
Mini-nutritional assessment form (MNA) (hospitalization, 1, 3 and 6 months).
Measured: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Nutritional status (Anthropometric measures)
Heigh in cm (hospitalization, 1, 3 and 6 months).
Measured: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Nutritional status (Anthropometric measures2)
Weight in kg (hospitalization, 1, 3 and 6 months).
Measured: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Nutritional status (Biochemical parameters)
Biochemical parameters from blood analysis (hospitalization, 3 and 6 months).
Measured: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Hydration status (bioimpedance)
Hydration status: we will register total body water and intracellular water with bioimpedance (hospitalization, 1, 3 and 6 months).
Measured: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Quality of life of patients during the study period
Quality of life: EQ-5D questionnaire will be used (hospitalization, 1, 3 and 6 months).
Measured: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Functional status
Functional status: we will use the Barthel Index (hospitalization, 1, 3 and 6 months).
Measured: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Oral Hygiene
Oral Hygiene: the OHI-S (simplified oroal hygiene index) will be collected (hospitalization, 1, 3 and 6 months).
Measured: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Dysphagia severity
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).
Measured: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start6 Jun 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Swallowing DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Mataró
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia Research
- Responsible party
- Principal investigator, Pere Clave, Hospital de Mataró
- Investigators
- Pere Clavé, MD, PhD, Principal investigator, Director of Research and Academic Development at CSdM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581486
- Sponsor's protocol ID
- OMI
- Acronym
- OMI
- Status last verified
- Jul 2022
- First submitted
- 15 Sep 2020
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29806864Ortega 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.
PubMed 28412164
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of an Optimal-Massive Intervention in Older Patients With Oropharyngeal Dysphagia
- ClinicalTrials.gov ID
- NCT04581486
- Acronym / sponsor ID
- OMI / OMI
- Conditions
- Swallowing Disorder, Oropharyngeal Dysphagia, Respiratory Infection, Malnutrition, Dehydration, Oral Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Collaborators
- Nutricia Research
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
DESIGN
- Study design: Randomized controlled clinical trial with two parallel arms and 6 months follow-up.
AIMS
- Primary aim: To evaluate the effect of a rheological, nutritional and oral hygiene intervention (OMI) on the incidence of respiratory infections including lower respiratory tract infections -LRTI-, pneumonia and chronic obstructive pulmonary disease (COPD) infectious exacerbations in older patients with OD at 6 months follow-up.
- Secondary aims: to evaluate the effect at 1, 3 and 6 months of this intervention on:
- Mortality.
- General hospital readmission and hospital readmission due to respiratory infections.
- Nutritional status according to the MNA, anthropometrical measures and biochemical markers.
- Hydration status according to bioimpedance.
- Quality of life according to the EQ-5D.
- Functional status according to Barthel index.
- Oral hygiene status according to the simplified oral hygiene index (OHI-S).
Other aims:
- To evaluate the effect at 1, 3 and 6 months of this intervention on:
- Swallowing function according to the V-VST.
- Rate of institutionalization.
- Compliance with the treatments (thickeners, ONS, diets and oral health).
- Palatability and acceptability of diets.
- To evaluate the relationship between severity of dysphagia (V-VST / FOIS), nutritional status, oral hygiene and the incidence of respiratory infections (LRTI, pneumonia and/or COPD exacerbations). STUDY POPULATION
- Study subjects: 500 older patients with OD admitted to Hospital de Mataró for acute conditions (internal medicine, cardiology, pneumology, neurology, geriatric wards, etc). Number of subjects necessary: 500 (G1: 250; G2: 250): Accepting an α risk of 0.05 and a β risk of 0.2 in a bilateral contrast, 244 subjects in each group are required to detect as statistically significant difference in the percentage of patients with LRTI at six months that for the control group is expected to be 20 % and for the intervention group of 10% (reduction by half).A tracking loss rate of 20% has been assumed and the required number of subjects (244) in each group already includes the dropout rate. Investigators will intend to recruit a total sample of 500* individuals, 250 in each intervention branch. SAFETY - Safety and tolerance parameters: Incidence, frequency, seriousness, severity and relatedness of adverse events or serious adverse events. STUDY GROUPS AND INTERVENTION
- Study groups: there will be 2 groups of patients: G1 - study intervention, 250 patients; G2 - control intervention, 250 patients.
- Study interventions:there will be 2 interventions: G1) study 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); G2) control intervention: standard clinical practice (fluid adaptation with Nutilis Powder® and simple texture adaptation (for solids (Nutilis Powder®)). STATISTICAL ANALYSIS
- Statistical analysis: the primary outcome will be the occurrence of the respiratory infections during the follow-up period (number of events/100 patients-year) and will be mainly analyzed with the Poisson regression. Qualitative data will be presented as relative and absolute frequencies and analyzed by the Fisher's exact test or the Chi-square test. Volume and viscosity levels (V-VST) will be compared between them by applying the McNemar's test. Continuous data will be presented as mean±standard deviation (SD) and compared with the T-test (intergroup comparisons) or Paired T-test (intragroup comparisons). For those variables that will not follow a normal distribution, the nonparametric Mann-Whitney U-test (intergroup comparisons), the Wilcoxon-paired test (intragroup comparisons) or the Kruskal-Wallis' test for multiple comparisons with Dunn's multiple comparison test will be used. Survival curves will be used to evaluate 6-month mortality after discharge. The primary analysis will be performed on the ITT population. Note: primary analysis is on number of events at 6 months follow-up, to simplify sample size considerations are based on percentage of patients with LRTI at 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMI intervention | Experimental | Other: Optimal-Massive InterventionMultimodal 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) |
| Control intervention (standard clinical practice) | Other | Other: Control (standard clinical practice)Standard clinical practice (fluid adaptation with Nutilis Powder® and simple texture adaptation (for solids (Nutilis Powder®)) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimal-Massive InterventionMultimodal 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). | Other | OMI intervention |
| Control (standard clinical practice)Standard clinical practice (fluid adaptation with Nutilis Powder® and simple texture adaptation (for solids (Nutilis Powder®)) | Other | Control intervention (standard clinical practice) |
Primary outcome
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.
11 secondary outcomes
Mortality
Time frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
General readmissions and readmissions for respiratory infections
Time frame: Through study completion, at 1, 3 and 6 months from disharge.
Nutritional status (MNA)
Time frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Nutritional status (Anthropometric measures)
Time frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Nutritional status (Anthropometric measures2)
Time frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Nutritional status (Biochemical parameters)
Time frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Hydration status (bioimpedance)
Time frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
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.
Functional status
Time frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Oral Hygiene
Time frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Dysphagia severity
Time frame: Through study completion, during hospitalization, and at 1, 3 and 6 months from disharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Results publication: PubMed 29806864Martin 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 publication: PubMed 28412164Ortega 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pere Clavé, MD, PhD principal investigator
Director of Research and Academic Development at CSdM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal-Massive Intervention in people with Swallowing Disorder and Oropharyngeal Dysphagia, run by Hospital de Mataró at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pere Clavé, MD, PhD (+34937417700 ext. 1046, pere.clave@ciberehd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory infections incidence. (time frame: From discharge to 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04581486, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.