The effect of comprehensive intervention with the clinical pathway for eating and swallowing disorder in the elderly with dementia

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN57646445

Enrollment

120

Registered

2015-12-08

Start date

2013-04-01

Completion date

Unknown

Last updated

2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

The subjects receive comprehensive geriatric assessment (CGA) through the original clinical pathway with multi-disciplinary interventions followed by the individualized therapeutic interventions accor

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 If they cannot be withdrawn from AHN before discharge from the hospital, they are considered to be failed 2.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. The survival rate is measured one year after withdrawal from AHN	—

Measure

Time frame

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. The survival rate is measured one year after withdrawal from AHN

—

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 9, 2026