UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032251 |
|---|---|
| Receipt number | R000036777 |
| Scientific Title | Randomized controlled trial about effect on patient's anxiety and troubles after discharge of telephone follow-up from nurse to care manager |
| Date of disclosure of the study information | 2018/05/07 |
| Last modified on | 2020/07/17 12:49:18 |
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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
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
t_domoto@kyotokango.ac.jp
Sponsor or person
Institute
Kyoto College of Nursing
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036777
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
