UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040903
Receipt number R000046647
Scientific Title Effect of bowel training and rational defecation posture on chronic functional constipation in elderly people with dementia, and evaluation of feasibility of defecation care practice by care staff.
Date of disclosure of the study information 2020/07/01
Last modified on 2021/11/02 19:08:04

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Basic information

Public title

Effects of bowel training and rational defecation posture on chronic constipation in elderly people with dementia.

Acronym

Effect of defecation care on constipation in the elderly with dementia.

Scientific Title

Effect of bowel training and rational defecation posture on chronic functional constipation in elderly people with dementia, and evaluation of feasibility of defecation care practice by care staff.

Scientific Title:Acronym

Effect of bowel training and rational defecation posture on chronic functional constipation in elderly people with dementia.

Region

Japan


Condition

Condition

Chronic constipation diadnosed by Rome IV criteria

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the effect of bowel training combined with rational bowel posture on chronic functional constipation in elderly people with dementia.
As a secondary study, we aim to examine the feasibility of defecation care by the care staff.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Monthly responder rates and weekly changes from baseline in complete spontaneous bowel movement.
Monthly responder rates and weekly changes from the baseline in spontaneous bowel movement.

Key secondary outcomes

1 The patient's assessment of constipation quality of life (JPAC-QOL)
2 Constipation Scoring System(CSS)
3 Neuropsychiatric Inventory Nursing Home Version (NPI-NH)
4 Change in laxative dose required.
5 Overall care efficacy.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Defecation care that combines bowel training and a rational defecation posture

Interventions/Control_2

Defecation care within the scope of normal care

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

1.Diagnosis according to the Rome 4 criteria
2.Diagnosis of dementia or daily living independence degree of demented elderly of 2 or more
3.Elderly people who keep sitting in the toilet.
4.Elderly people capable of daily conversation.

Key exclusion criteria

1.Colostomy
2.Tube feeding
3.Secondary constipation
4.Those judged ineligible to participate in the research by the doctor in charge.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Tomoyoshi
Middle name
Last name Naito

Organization

Hamamatsu University School of Medicine

Division name

Faculty of Nursing

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu

TEL

053-435-2511

Email

t-naito@hama-med.ac.jp


Public contact

Name of contact person

1st name Tomoyoshi
Middle name
Last name Naito

Organization

Hamamatsu University School of Medicine

Division name

Faculty of Nursing

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu

TEL

053-435-2511

Homepage URL


Email

t-naito@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hamamatsu University School of Medicine

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hamamatsu University School of Medicine

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu

Tel

053-435-2511

Email

t-naito@hama-med.ac.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



Other administrative information

Date of disclosure of the study information

2020 Year 07 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 04 Month 17 Day

Date of IRB

2020 Year 06 Month 18 Day

Anticipated trial start date

2020 Year 08 Month 01 Day

Last follow-up date

2022 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 06 Month 25 Day

Last modified on

2021 Year 11 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046647


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name