UMIN-CTR Clinical Trial

Basic information
Public title	Adverse effects of physical restraint on the activities of daily living among older inpatients in an acute care hospital: a retrospective cohort study
Acronym	Adverse effects of physical restraint on the activities of daily living among older inpatients in an acute care hospital: a retrospective cohort study
Scientific Title	Adverse effects of physical restraint on the activities of daily living among older inpatients in an acute care hospital: a retrospective cohort study
Scientific Title:Acronym	Adverse effects of physical restraint on the activities of daily living among older inpatients in an acute care hospital: a retrospective cohort study
Region	Japan

Condition
Condition	Pneumonia
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to investigate the adverse effects of physical restraint on ADL in older inpatients in acute care settings.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ADL at discharge defined by the Katz ADL Scale
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	This study included patients aged 65 years or older who were diagnosed with pneumonia and admitted to Shirakawa Kosei General Hospital between April 2015 and September 2017.
Key exclusion criteria	Patients who were transferred from other hospitals or those who died were excluded.
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Shoko Middle name Last name Soeno
Organization	Shirakawa Satellite for Teaching and Research (STAR)
Division name	Department of General Medicine
Zip code	961-0005
Address	2-1 Toyochikamiyajiro, Shirakawa, Fukushima
TEL	0248-22-2211
Email	shoko.soeno@gmail.com

Public contact
Name of contact person	1st name Shoko Middle name Soeno Last name Soeno
Organization	Shirakawa Satellite for Teaching and Research (STAR)
Division name	Department of General Medicine
Zip code	961-0005
Address	2-1 Toyochikamiyajiro, Shirakawa, Fukushima
TEL	0248-22-2211
Homepage URL
Email	shoko.soeno@gmail.com

Sponsor
Institute	Shirakawa Satellite for Teaching and Research (STAR)
Institute
Department

Funding Source
Organization	The Japan Primary Care Association
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fukushima Medical University Certified Review Board
Address	1, Hikarigaoka, Fukushima, Fukushima
Tel	024-547-1825
Email	fmucrb@fmu.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	2019 Year 10 Month 31 Day

Related information
URL releasing protocol	not available
Publication of results	Published

Result
URL related to results and publications	https://www.sciencedirect.com/science/article/abs/pii/S0167494320303265?via%3Dihub
Number of participants that the trial has enrolled	403
Results	Of 403 patients, 94 required physical restraints. The mean age was 84.5 years (standard deviation [SD] 8.2); 44.4% were women. The mean Katz score on admission was 2.7 (SD 2.4). For multiple linear regression analysis, the coefficient of the number of restraints used was -0.024 (95% confidence interval: -0.044, -0.003, p = .022). Consequently, the restraint use for 13.9 days was associated with the decrease in the Katz score by 1.0.
Results date posted	2022 Year 11 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	This retrospective cohort study was conducted at a 471-bed, acute care hospital in Japan.
Participant flow	Patients 65 years old and older who were admitted with pneumonia between April 2015 and September 2017 were included.
Adverse events	fall
Outcome measures	The use of restraints (belts and/or mittens) was recorded for every 8-hour shift. The number of shifts during which each patient was restrained was used as an explanatory variable. The primary outcome was the Katz ADL score at discharge. We used multiple linear regression analysis to adjust for confou
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 01 Day
Date of IRB	2017 Year 03 Month 31 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2019 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Data were extracted from electronic medical records and the Diagnosis Procedure Combination database of the hospital. Belts, mittens, and bed alarms were defined as physical restraints. The use of these devices and techniques were recorded every 8 hours by nurses. The primary outcome was ADL at discharge defined by the Katz ADL Scale. The secondary outcomes were the incidence of falls, device removal, and pressure ulcers. The incidence of these events was extracted from incidence reports made by nurses. The confounding factors(age, sex, dementia, etc.) were also extracted from electronic medical records and DPC database.

Management information
Registered date	2019 Year 10 Month 31 Day
Last modified on	2022 Year 11 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043811