Deglutition DisordersDEMNCT01006330
Dysphagia in Elderly Medical Patients
An observational study of Deglutition Disorders and Impaired Cognition, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Dysphagia in hospitalized elders is associated with less positive outcomes in rehabilitation, increased likelihood of readmission, increased comorbidity and mortality, and increased length of hospital stay. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Deglutition Disorders, Impaired Cognition, Physical Activity
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2009to Jun 2011
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 102 internal medical patients admitted to Herlev Hospital are included consecutively.
Who may be able to join
- > 65 years
- needs > 2 days of hospitalization
- are able to give personal information regarding self, place and time
- are alert > 30 minutes
- are able to maintain an upright seating position and head control
- are able to swallow saliva spontaneously and on command
Show all 9Show fewer
- are able to voluntary cough or clear the throat twice
- working knowledge of the Danish language
- consent to participate and able to give written informed consent.
Who cannot join
- needs oral/pharyngeal suctioning
- use of tube feeding for more than half of the caloric requirements
- tracheostomy
- terminally ill
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Occupational Therapy department, Herlev Hospital
Herlev, The Capital Region, 2730
About this study
Official title: Dysphagia in Elderly Medical Patients: Occupational Therapy Evaluation and Prevalence
Dysphagia in hospitalized elders is associated with less positive outcomes in rehabilitation, increased likelihood of readmission, increased comorbidity and mortality, and increased length of hospital stay. In light of an increase in the elderly population in Denmark, the consequences of dysphagia, and the importance of minimizing the risk of disability and frailty, it is vital to emphasize safe participation of the elderly dysphagic patient in eating, drinking and swallowing. Danish occupational therapists have an important role in the dysphagia management, but no Danish evidence-based occupational therapy assessments for dysphagia of elderly medical patients exist. In order to oblige this lack, the objective of the study is to provide an assessment tool with operational definitions of dysphagia which includes the complexity of performance in eating, drinking and swallowing, is evidence-based, and guides occupational therapists in the treatment planning in a client-centred and purposeful manner.
The study involves a quantitative approach, and is initiated by a translation and cultural adaptation of the Canadian "The McGill Ingestive Skills Assessment" (MISA). Hereafter, the psychometric qualities are tested. On basis of the data collected for the psychometrics, the prevalence and characteristics of dysphagia in the study population are investigated. Provided that the psychometric testing of the MISA reveals satisfactory levels, the effect of using the MISA in the treatment planning is investigated.
Read more
It is hypothesized that:
The Danish translation of the MISA will demonstrates satisfactory content validity, reliabilities, convergent validity, known-groups validity, predictive validity, criterion validity, high levels of sensitivity/specificity and are responsive to change.
Dysphagia is prevalent in elderly medical patients at the time of admission to acute medical care and there can be found a correlation between dysphagia severity and the presence of comorbidity, disability, frailty, the length of hospital stay, the place of discharge and the number of readmissions for elderly medical patients.
Read the detailed description
The study is divided into four study parts.
Study I aims to translate and cultural adapt the MISA into Danish occupational therapy terminology, to secure equivalency between the original and the translated version, and to test its interrater- and intrarater reliability as well as internal consistency.
Study II aims to investigate the convergent validity, known-groups validity, predictive validity and the responsiveness of the MISA.
Study III aims to test the criterion-related validity and the diagnostic accuracy of the MISA using the Flexible Endoscopic Evaluation of Swallowing (FEES) and the Assessment of Motor and Process Skills (AMPS) as gold standards; and to compare the diagnostic accuracy for aspiration of the MISA compared to the Water Swallow Test, when using the FEES as the gold standard.
Study IV aims to investigate the prevalence and characteristics of dysphagia in elderly medical patients, and to identify its potential associations between comorbidity, disability, frailty, length of hospital stay, place of discharge and number of readmissions.
- Conditions
- Deglutition Disorders, Impaired Cognition, Physical Activity, Complete Immobility Due to Frailty, Respiratory Tract Infections
- Medical subject headings
- Deglutition Disorders, Cognition Disorders, Motor Activity, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly medical inpatients | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tina Hansen, MSc PHD stud, Principal investigator, Herlev Hospital, Region H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006330
- Sponsor's protocol ID
- CVR29190623
- Other IDs
- HC-2009-061
- Acronym
- DEM
- Status last verified
- Oct 2009
- First submitted
- 30 Oct 2009
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysphagia in Elderly Medical Patients: Occupational Therapy Evaluation and Prevalence
- ClinicalTrials.gov ID
- NCT01006330
- Acronym / sponsor ID
- DEM / CVR29190623
- Conditions
- Deglutition Disorders, Impaired Cognition, Physical Activity, Complete Immobility Due to Frailty, Respiratory Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Nov 2009 (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.
Dysphagia in hospitalized elders is associated with less positive outcomes in rehabilitation, increased likelihood of readmission, increased comorbidity and mortality, and increased length of hospital stay. In light of an increase in the elderly population in Denmark, the consequences of dysphagia, and the importance of minimizing the risk of disability and frailty, it is vital to emphasize safe participation of the elderly dysphagic patient in eating, drinking and swallowing. Danish occupational therapists have an important role in the dysphagia management, but no Danish evidence-based occupational therapy assessments for dysphagia of elderly medical patients exist. In order to oblige this lack, the objective of the study is to provide an assessment tool with operational definitions of dysphagia which includes the complexity of performance in eating, drinking and swallowing, is evidence-based, and guides occupational therapists in the treatment planning in a client-centred and purposeful manner.
The study involves a quantitative approach, and is initiated by a translation and cultural adaptation of the Canadian "The McGill Ingestive Skills Assessment" (MISA). Hereafter, the psychometric qualities are tested. On basis of the data collected for the psychometrics, the prevalence and characteristics of dysphagia in the study population are investigated. Provided that the psychometric testing of the MISA reveals satisfactory levels, the effect of using the MISA in the treatment planning is investigated.
It is hypothesized that:
The Danish translation of the MISA will demonstrates satisfactory content validity, reliabilities, convergent validity, known-groups validity, predictive validity, criterion validity, high levels of sensitivity/specificity and are responsive to change.
Dysphagia is prevalent in elderly medical patients at the time of admission to acute medical care and there can be found a correlation between dysphagia severity and the presence of comorbidity, disability, frailty, the length of hospital stay, the place of discharge and the number of readmissions for elderly medical patients.
Detailed description
The study is divided into four study parts.
Study I aims to translate and cultural adapt the MISA into Danish occupational therapy terminology, to secure equivalency between the original and the translated version, and to test its interrater- and intrarater reliability as well as internal consistency.
Study II aims to investigate the convergent validity, known-groups validity, predictive validity and the responsiveness of the MISA.
Study III aims to test the criterion-related validity and the diagnostic accuracy of the MISA using the Flexible Endoscopic Evaluation of Swallowing (FEES) and the Assessment of Motor and Process Skills (AMPS) as gold standards; and to compare the diagnostic accuracy for aspiration of the MISA compared to the Water Swallow Test, when using the FEES as the gold standard.
Study IV aims to investigate the prevalence and characteristics of dysphagia in elderly medical patients, and to identify its potential associations between comorbidity, disability, frailty, length of hospital stay, place of discharge and number of readmissions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly medical inpatients | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 102 internal medical patients admitted to Herlev Hospital are included consecutively.
Key inclusion criteria (9 listed)
- > 65 years
- needs > 2 days of hospitalization
- are able to give personal information regarding self, place and time
- are alert > 30 minutes
- are able to maintain an upright seating position and head control
Key exclusion criteria (4 listed)
- needs oral/pharyngeal suctioning
- use of tube feeding for more than half of the caloric requirements
- tracheostomy
- terminally ill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 16 Jun 2011.
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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.
Tina Hansen, MSc PHD stud principal investigator
Herlev Hospital, Region H
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deglutition Disorders and Impaired Cognition, run by Herlev Hospital at 1 site in Denmark.
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 9 inclusion and 4 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 16 Jun 2011. 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 Denmark. 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.
Where can I read the original study information?
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 16 Jun 2011.