UMIN-CTR Clinical Trial

Basic information
Public title	The effect of nursing discharge planning program to prevent recurrent falls, readmission, and length of hospital stay in the aged patients: A Randomized Clinical Trial
Acronym	nursing discharge planning program to prevent recurrent falls
Scientific Title	The effect of nursing discharge planning program to prevent recurrent falls, readmission, and length of hospital stay in the aged patients: A Randomized Clinical Trial
Scientific Title:Acronym	nursing discharge planning program to prevent recurrent falls
Region	Asia(except Japan)

Condition
Condition	Recurrent falls
Classification by specialty	Geriatrics Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to prevent recurrent falls
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	reduce the number of recurrent falls 30 days after discharge
Key secondary outcomes	reduce hospital readmission reduce the length of hospitalstay

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Nursing discharge planning program
Interventions/Control_2	routine treatment
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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	hospitalization for falls
Key exclusion criteria	being under similar training in the previous episode of hospitalization, suffering from acute physical illness, being under the treatment of psychotropic medications that influence their balance, transfer to another medical center or nursing home, the presence of absolute mobility disability, not attending more than one training session were excluded.
Target sample size	112

Research contact person
Name of lead principal investigator	1st name Ali Middle name Last name Dadgari
Organization	Shahroud University of Medical Sciences
Division name	Geriatric Nursing
Zip code	3613883655
Address	7 tir, Shahroud, Semnan, Iran
TEL	+989123733539
Email	adadgari@yahoo.com

Public contact
Name of contact person	1st name Ali Middle name Last name Dadgari
Organization	Shahroud
Division name	Geriatric Nursing
Zip code	3613883655
Address	7 tir, Shahroud, Semnan, Iran
TEL	+989123733539
Homepage URL
Email	adadgari@yahoo.com

Sponsor
Institute	Shahroud University of Medical Sciences
Institute
Department

Funding Source
Organization	Shahroud University of Medical Sciences
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	Iranian

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

IRB Contact (For public release)
Organization	Shahroud University of Medical Sciences
Address	7 tir, Shahroud, Semnan, Iran
Tel	0098323395054
Email	adadgari@yahoo.com

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	Shahroud University of Medical Sciences

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 10 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	112
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	2018 Year 08 Month 10 Day
Date of IRB	2018 Year 11 Month 10 Day
Anticipated trial start date	2019 Year 02 Month 10 Day
Last follow-up date	2020 Year 08 Month 10 Day
Date of closure to data entry	2020 Year 08 Month 30 Day
Date trial data considered complete	2020 Year 10 Month 01 Day
Date analysis concluded	2020 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2021 Year 01 Month 06 Day
Last modified on	2021 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049003