UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled trial about effect on patient's anxiety and troubles after discharge of telephone follow-up from nurse to care manager
Acronym	Randomized controlled trial about effect on telephone follow-up from nurse to care manager
Scientific Title	Randomized controlled trial about effect on patient's anxiety and troubles after discharge of telephone follow-up from nurse to care manager
Scientific Title:Acronym	Randomized controlled trial about effect on telephone follow-up from nurse to care manager
Region	Japan

Condition
Condition	All diseases
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This research aims to clarify the effect on patient's anxiety and troubles after discharge of telephone follow-up from nurse to care manager.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patient's anxiety and troubles (two weeks after discharge)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Three times telephone follow-up after discharge (1week,1month,2month) from nurse to care manager
Interventions/Control_2	Usual follow-up after discharge
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.Patients older than 65 who receive Long-Term Care Insurance and are discharged from hospital to the home 2.Care managers in charge of those patients 3.Patients and care managers that the agreement of study entry was provided from both them
Key exclusion criteria	Patients who are discharged from the hospital to any place other than home
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Tsukasa Middle name Last name Domoto
Organization	Kyoto College of Nursing
Division name	Faculty of Nursing, Department of Nursing
Zip code	604-8845
Address	1-21 Mibu-higashitakada-cho,Nakagyo-ku,Kyoto
TEL	075-311-0123
Email	t_domoto@kyotokango.ac.jp

Public contact
Name of contact person	1st name Tsukasa Middle name Last name Domoto
Organization	Kyoto College of Nursing
Division name	Faculty of Nursing, Department of Nursing
Zip code	604-8845
Address	1-21 Mibu-higashitakada-cho,Nakagyo-ku,Kyoto
TEL	075-311-0123
Homepage URL
Email	t_domoto@kyotokango.ac.jp

Sponsor
Institute	Kyoto College of Nursing
Institute
Department

Funding Source
Organization	MEXT(Japan) Japan Society for the Promotion of Science
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	Sonoda Women's University
Address	7-29-1, Minami Tsukaguchi-cho, Amagasaki, Hyogo
Tel	06-6429-9641
Email	chiikirenkei@sonoda-u.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	尼崎新都心病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 07 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	2018 Year 05 Month 02 Day
Date of IRB	2018 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 05 Month 07 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 14 Day
Last modified on	2020 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036777