Oropharyngeal DysphagiaMMINCT02396992
Minimal-Massive Intervention in Elderly Patients With Dysphagia
A study testing Minimal-Massive Intervention in people with Oropharyngeal Dysphagia, run by Hospital de Mataró at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Oropharyngeal Dysphagia
- What is being tested?
- Minimal-Massive Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2014to Sep 2015
- 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
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital de Mataró. Consorci Sanitari del Maresme.
Mataró, Barcelona, 08304
About this study
Official title: Evaluation of a Minimal-massive Intervention in Elderly Hospitalized Patients With Oropharyngeal Dysphagia
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.
Read the 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.
- Conditions
- Oropharyngeal Dysphagia
- Being tested
- Minimal-Massive Intervention
- Keywords
- Oropharyngeal Dysphagia, Aspiration pneumonia, Malnutrition, Oral Health, Bacterial colonization, Aging
- Medical subject headings
- Deglutition Disorders, Pneumonia, Aspiration, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Minimal-Massive Intervention | Other | The minimal/basic intervention for a massive number of hospitalized patients. Receives: Other: Minimal-Massive Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year after discharge
Secondary outcomes (4)
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.
Measured: One year after discharge
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.
Measured: One year after discharge
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.
Measured: One year after discharge
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.
Measured: One year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMar 2014
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal DysphagiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Mataró
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pere Clave, Hospital de Mataró
- Investigators
- Pere Clavé, PhD; MD, Principal investigator, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396992
- Sponsor's protocol ID
- IMM2013-14
- Acronym
- MMI
- Status last verified
- Apr 2019
- First submitted
- 25 Jun 2014
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- 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 29806864
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Minimal-massive Intervention in Elderly Hospitalized Patients With Oropharyngeal Dysphagia
- ClinicalTrials.gov ID
- NCT02396992
- Acronym / sponsor ID
- MMI / IMM2013-14
- Conditions
- Oropharyngeal Dysphagia
- Keywords
- Oropharyngeal Dysphagia, Aspiration pneumonia, Malnutrition, Oral Health, Bacterial colonization, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 Mar 2015 (estimated)
- 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimal-Massive Intervention | Other | Other: Minimal-Massive InterventionThe minimal/basic intervention for a massive number of hospitalized patients. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
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 |
|---|---|---|
| Minimal-Massive InterventionThe 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). | Other | Minimal-Massive Intervention |
Primary outcome
Reduction of incidence of respiratory infections due to the intervention.
Time frame: One year after discharge
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.
4 secondary outcomes
Improvement of signs and symptoms of oropharyngeal dysphagia
Time frame: One year after discharge
Improvement of nutritional status of the patients enrolled.
Time frame: One year after discharge
Improvement of oral health and hygiene of the patients enrolled.
Time frame: One year after discharge
Improvement of quality of life of patients enrolled.
Time frame: One year after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Derived from this study: 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.
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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, PhD; MD principal investigator
Hospital de Mataró
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal-Massive Intervention in people with 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 1 May 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of incidence of respiratory infections due to the intervention. (time frame: One year after discharge). 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 NCT02396992, which also lists 1 linked publication.
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 1 May 2019.