UMIN-CTR Clinical Trial

Public title

Research to verify the effects of KT index in swallowing function improvement of the older patients with pneumonia

Acronym

Research to verify the effects of KT index

Scientific Title

Research to verify the effects of KT index in swallowing function improvement of the older patients with pneumonia

Scientific Title:Acronym

Research to verify the effects of KT index

Region

Japan

Condition

Older patients (65 years and over) with pneumonia

Classification by specialty

Medicine in general	Pneumology	Rehabilitation medicine
Nursing

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify whether comprehensive intervention with KT index improve the swallowing function of the older patients with pneumonia or not.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Functional Oral intake Scale of the older patients with pneumonia at discharge or one month after admission

Key secondary outcomes

Nutritional intake on admission intake (including both parenteral and enteral artificial nutrition), ADL (Barthel Index each item and the total score), hospital discharge rate (15 days, 30 days after admission), period of Nil per Os after admission, discharge upon oral ingestion the presence or absence of resuming oral intake at discharge, period of antibiotic administration, home discharge rate, mortality

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

･Multidisciplinary comprehensive evaluation and intervention
･Recording on the time-series evaluation sheet: index comprised 13 items. each item is rated from 1 (worst) to 5 (best) points.
･Once a week or more of multidisciplinary meeting with the time-series evaluation sheet.
･Professional assessment and treatment for the items with lower evaluation point.
･The maintenance and strengthening for the items with higher evaluation point.
･Medical intervention, such as medication or oxygen administration to improve overall condition.
･Dysphagia rehabilitation to improve swallowing function.
･Intervention for keep position and endurance while eating and improve daily activities.
･Confirmation of dietary intake level and food texture for adequate nutritional status.

Interventions/Control_2

･Once a week or more of multidisciplinary meeting for adequate evaluation and intervention.
･Standard treatment for the patients with pneumonia

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

･The patients with pneumonia admitted to the hospital
･The patients with written informed consent.

Key exclusion criteria

･The case who does not have oral intake before admission.
･The case with mild pneumonia (A-DROP Score 0), or the case who is not hospitalized.
･The case who does not agree to the study participants
･The case who has not been consulted to the team

Target sample size

200

Name of lead principal investigator

1st name	Hiroshi
Middle name
Last name	Shamoto

Organization

Fukushima Medical University
Minamisoma Municipal General Hospital

Division name

Department of Disaster and Comprehensive medicine, Department of Neurosurgery

Zip code

960-1247

Address

2-54-6 Takami-chou, Haramachi ward, Minamisoma City, Fukushima, Japan 975-0033

TEL

0244-22-3181

Email

hshamoto@rc4.so-net.ne.jp

Name of contact person

1st name	Hiroshi
Middle name
Last name	Shamoto

Organization

Fukushima Medical University, Minamisoma Municipal General Hospital

Division name

Department of Disaster and Comprehensive medicine, Department of Neurosurgery

Zip code

960-1247

Address

2-54-6 Takami-chou, Haramachi ward, Minamisoma City, Fukushima, Japan 975-0033

TEL

0244-22-3181

Homepage URL

Email

hshamoto@rc4.so-net.ne.jp

Institute

Non-profit organization Kuchi-kara Taberu Shiawase-wo Mamoru-kai, Kanagawa, Japan

Institute

Department

Personal name

Organization

Non-profit organization Kuchi-kara Taberu Shiawase-wo Mamoru-kai, Kanagawa, Japan

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

None

Name of secondary funder(s)

None

Organization

Minamisoma Municipal General Hospital

Address

2-54-6 Takami-chou, Haramachi ward, Minamisoma City, Fukushima, Japan 975-0033

Tel

0244-22-3181

Email

sato.ryo@city.minamisoma.lg.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

玉名郡市医師会立 玉名地域保健医療センター（熊本県）、南相馬市立総合病院（福島県）
Tamana Regional Health Medical Center, Minamisoma Municipal General Hospital

Date of disclosure of the study information

2016

Year

12

Month

07

Day

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000028615

Publication of results

Published

URL related to results and publications

https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000028615

Number of participants that the trial has enrolled

112

Results

The median FOIS level and the number of patients with oral intake at discharge were 4 (IQR 4-6) and 89, respectively. The duration of nil per os was 2 (IQR 1-5) days. Clusters were not matched in the presence of KT-certified medical stuff. The median FOIS levels of 53 patients in the intervention group and 59 patients in the control group were 5 (IQR 4-6) and 4 (IQR 4-5), respectively, showing no statistically significant differences (P=0.76).

Results date posted

2020

Year

01

Month

20

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Patients 65 years and older admitted to the hospitals with pneumonia were enrolled in the study. One hundred and twelve patients who participated from 10 hospitals, with a median age of 88 years (IQR 80-91), were examined.

Participant flow

Patients without ordinary food intake at admission, with mild pneumonia (A-DROP Score 0, described later), who did not agree to participate in the trial, and who had not been referred to the multidisciplinary comprehensive care (MDCC) team were excluded.

Adverse events

None

Outcome measures

Primary Outcomes
The Functional Oral Intake Scale (FOIS) at discharge or 1 month after admission
Secondary Outcomes
Duration of hospitalization, duration of nil per os after admission, resumption of oral intake at discharge, nutritional intake (kcal) at discharge or 1 month after admission, and period of antibiotic administration

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

12

Month

07

Day

Date of IRB

2016

Year

10

Month

13

Day

Anticipated trial start date

2017

Year

02

Month

01

Day

Last follow-up date

2018

Year

01

Month

31

Day

Date of closure to data entry

2018

Year

02

Month

28

Day

Date trial data considered complete

2018

Year

04

Month

30

Day

Date analysis concluded

2018

Year

05

Month

31

Day

Other related information

Registered date

2016

Year

12

Month

07

Day

Last modified on

2020

Year

01

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028615