Condition category
Nervous System Diseases
Date applied
02/12/2015
Date assigned
08/12/2015
Last edited
09/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The natural clinical course of advanced dementia has been reported in a few studies. They often experience problems with eating and drinking, but the reason for this has not been clarified. The causes for any individual patient can be unclear, because most of those patients are nearing the end-of-life and are not likely to be assessed adequately. However, the prognosis of these patients can be improved by giving them treatments (or interventions) that help them to be able to eat. In Japan, it is recommended that elderly patients have a comprehensive geriatric assessment (CGA). This has been shown to improve their functional status (that is, improve their ability to perform normal daily activities) and prognosis for some diseases (for example, chronic heart failure and pneumonia). This study investigates whether an intervention based on CGA can also help patients suffering from eating and swallowing disorder of the elderly with dementia (ESDED).A special ESDED team has been set up called the "Eating and Swallowing Assessment Team (ESAT)" which consists of medical doctors, dentists, dental hygienists, pharmacists, nurses, speech therapists, physical therapists, occupational therapists, dieticians and certified care workers. This team has developed a new system to examine ESDEDs using the original clinical pathway (CP). This CP involves assessments by each specialist and integration of their findings followed by diagnosing the etiology (cause) of ESDED in each patient. Based on the diagnosis, ESAT designs various interventional methods (treatments) and passes this information to the medical staff treating the ESDED. This study looks at whether this medical care system based on CGA improves the ability of eating and prognosis of the patients with ESDEDs.

Who can participate?
Elderly patients aged over 70 with cognitive impairment (difficulties in thinking and memory), who need to be treated with artificial hydration and/or nutrition.

What does the study involve?
Each participant has a CGA developed by the ESAT. For the first two days this involves assessing the patients various functions (physical, cognitive, chewing, swallowing, and sensory), collecting their past medical and medication history, and obtaining detailed information of their eating problems. The team perform a physical and dental examination, urine and blood examination, chest X-ray, electrocardiogram, and magnetic resonance imaging of the brain of each patient. In addition, the behavior and reaction of each patient during nursing at dinner is observed and a list of the problems that they are having swallowing is drawn up. On the third day, a video-endoscopic examination of the patients swallowing is done, after which the ESAT decides the cause of the problems each patient has with eating. This is based on all the data that has been collected. The ESAT then plans
further assessment or examination in order to identify the details of the etiology for each patient. On days 4 and 5, the ESAT perform the planned assessment or examinations and makes the final diagnosis for the etiology of the eating problem experienced by each patient. Based on the diagnosis, ESAT proposes various interventional strategies to the medical staff who treat the ESDED.

What are the possible benefits and risks of participating?
The participants might be able to be withdrawn from AHN. However, they might have a risk of receiving an excessive assessment or intervention, which would be unnecessary for their original medical care.

Where is the study run from?
Nanto Municipal Hospital (Japan)

When is study starting and how long is it expected to run for?
April 2012 to June 2016

Who is funding the study?
Japan Primary Care Association

Who is the main contact?
Dr Masahisa Arahata

Trial website

Contact information

Type

Scientific

Primary contact

Dr Masahisa Arahata

ORCID ID

http://orcid.org/0000-0002-3759-0724

Contact details

Nanto Municipal Hospital
938 Inami
Nanto
939-0211
Japan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of comprehensive assessment with multi-disciplinary interventions for eating and swallowing disorders in the elderly with dementia; non-randomized, historical controlled, interventional study

Acronym

Study hypothesis

The comprehensive assessment with multi-disciplinary interventions could determine the details of etiologies of eating and swallowing disorders in the elderly patients with dementia, which would help the improvement of the functional status of the eating leading to better overall survival of those patients.

Ethics approval

The Institutional Review Board of Nanto Municipal Hospital, 21/03/2013, ref: # 664 of Nanto Municipal Hospital

Study design

Non randomized, historical controlled, interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Eating and swallowing disorder of the elderly with dementia (ESDED)

Intervention

The subjects receive comprehensive geriatric assessment (CGA) through the original clinical pathway with multi-disciplinary interventions followed by the individualized therapeutic interventions according to the assessment of the etiology of their eating problems.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

1. Recovery rate (RR): RR represents the rate of participants who become free from AHN by taking enough amounts of nutrition and water orally for at least 7 days (longer than 7 days). If they cannot be withdrawn from AHN before discharge from the hospital, they are considered to be failed.
2. AHN free survival (AHNFS): AHFNS represents the survival rate of participants who have become free from AHN. AHFNS is assessed by Kaplan Meier method, in which each participant is estimated to reach the endpoint if the participant is dead or becomes dependent on AHN. We measure the survival rate one year after withdrawal from AHN.

Secondary outcome measures

The overall survival (OS) after onset of ESDED: OS is assessed by Kaplan Meier method, in which each participant’s endpoint is death. We measure the survival rate one year after the onset of ESDED.

Overall trial start date

01/04/2012

Overall trial end date

30/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Participants were required to meet all the following five criteria, all of which are the characteristics of ESDED:
1. A hospitalized patient aged over 70
2. Cognitive impairment (Mini-Mental-State-Examination <24, or Hasegawa-Dementia-rating-Scale-Revised <21)
3. A patient who did not receive intravenous or surgical treatment for past 7 days
4. Oral intake is no more than 500 kilo-calories per day
5. Dependent on AHN for over 7 days

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

120

Participant exclusion criteria

Potential participants are excluded from this trial if they meet any of the following criteria:
1. A patient who has determined to depend on persistent tube-feeding
2. A patient with morphological anomaly due to a tracheotomy or an operation to remove all or a part of the larynx
3. A patient who has been receiving an end-of-life care

Recruitment start date

01/04/2013

Recruitment end date

31/03/2015

Locations

Countries of recruitment

Japan

Trial participating centre

Nanto Municipal Hospital
938 Inami
Nanto
932-0211
Japan

Sponsor information

Organisation

Nanto Municipal Hospital

Sponsor details

938 Inami
Nanto
932-0211
Japan

Sponsor type

Hospital/treatment centre

Website

http://shiminhp.city.nanto.toyama.jp/

Funders

Funder type

Government

Funder name

Japan Primary Care Association

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We will collect all the data of outcomes until July, 2016. Therefore, we will write and submit the article on this study in August or September, 2016. We have not decided to which journal we submit our article.

Intention to publish date

30/09/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes