UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046928 |
|---|---|
| Receipt number | R000053541 |
| Scientific Title | Development of a Telenursing Program to Support Mental Health and Sleep in Chronic Heart Failure Patients: A Pilot Study |
| Date of disclosure of the study information | 2022/02/17 |
| Last modified on | 2024/02/22 14:48:36 |
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Basic information
Public title
Development of a Telenursing Program to Support Mental Health and Sleep in Chronic Heart Failure Patients: A Pilot Study
Acronym
Development of a Telenursing Program to Support Mental Health and Sleep in Chronic Heart Failure Patients: A Pilot Study
Scientific Title
Development of a Telenursing Program to Support Mental Health and Sleep in Chronic Heart Failure Patients: A Pilot Study
Scientific Title:Acronym
Development of a Telenursing Program to Support Mental Health and Sleep in Chronic Heart Failure Patients: A Pilot Study
Region
| Japan |
Condition
Condition
chronic heart failure, insomnia
Classification by specialty
| Cardiology | Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a telenursing program to support mental health and sleep for heart failure patients who are treated at home. This is a pilot study. We implement this program to small number of subjects to examine the content, and evaluation indicators, and feasibility of the program.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Insomnia Severity Index Japanese
-Pittsburgh Sleep Quality Index
-Sleep Data
-Hospital Anxiety and Depression Scale
Key secondary outcomes
-Kansas City Cardiomyopathy Questionnaire
-Questionnaire about the Program
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Implement a support program to improve sleep and mental health. Four homework sessions and four web nursing interviews to be conducted in 8 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Heart failure,Outpatient
2) ISI-J:8-21
3) People who have WiFi and can operate a smartphone or tablet.
4) Physician agrees to participate.
5) Japanese speakers
Key exclusion criteria
1) NYHA:class IV
2) Suspected or diagnosed sleep apnea. Epworth Sleepiness Scale score:more than 11
3) Suspected or diagnosed restless legs syndrome
4) Working in shifts
5) Under psychiatric treatment
6) Started sleeping pills or changed medications in the past 3 months
7) Cognitive impairment
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kiyoka |
| Middle name | |
| Last name | Nozue |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3732
nozue@keio.jp
Public contact
Name of contact person
| 1st name | Michiyo |
| Middle name | |
| Last name | Takubo |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3734
Homepage URL
mtakubo@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2022 | Year | 02 | Month | 17 | 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
4
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
| 2022 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 23 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 16 | Day |
Last modified on
| 2024 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053541
