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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025172
Receipt No. R000028615
Scientific Title Research to verify the effects of KT index in swallowing function improvement of the older patients with pneumonia
Date of disclosure of the study information 2016/12/07
Last modified on 2020/01/30

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Basic information
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
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

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

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

Funding Source
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

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 07 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000028615
Publication of results Published

Result
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

Progress
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
Other related information

Management information
Registered date
2016 Year 12 Month 07 Day
Last modified on
2020 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028615

Research Plan
Registered date File name
2019/02/26 KTBCランダム化試験(詳細).pdf

Research case data specifications
Registered date File name
2019/05/15 data set.pdf

Research case data
Registered date File name
2019/05/15 data for analysis.pdf


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