UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038448 |
|---|---|
| Receipt number | R000043811 |
| 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 |
| Date of disclosure of the study information | 2019/10/31 |
| Last modified on | 2022/11/02 11:35:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
shoko.soeno@gmail.com
Sponsor or person
Institute
Shirakawa Satellite for Teaching and Research (STAR)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043811
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
