UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055232 |
|---|---|
| Receipt number | R000062968 |
| Scientific Title | Evaluation of a Telenursing Program for Improving Sleep and Mental Health in Heart Failure Patients: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/08/13 |
| Last modified on | 2025/09/03 14:20:14 |
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Basic information
Public title
Evaluation of a Telenursing Program for Improving Sleep and Mental Health in Heart Failure Patients: A Randomized Controlled Trial
Acronym
Evaluation of a Telenursing Program for Improving Sleep and Mental Health in Heart Failure Patients: A Randomized Controlled Trial
Scientific Title
Evaluation of a Telenursing Program for Improving Sleep and Mental Health in Heart Failure Patients: A Randomized Controlled Trial
Scientific Title:Acronym
Evaluation of a Telenursing Program for Improving Sleep and Mental Health in Heart Failure Patients: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is a pilot randomized controlled trial to investigate the feasibility of a large-scale randomized controlled trial to test the effectiveness of a program that supports sleep and mental health in heart failure patients using telenursing, and the effect size of the nursing intervention through a pilot randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese version of the Insomnia Severity Index
Key secondary outcomes
･The Japanese version of the Patient Health Questionnaire-9
･The Japanese version of the Pittsburgh Sleep Quality Index
･Sleep Data
･The Kansas City Cardiomyopathy Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Implement a telenursing program for improving sleep and mental health, with four homework sessions and four educational sessions over an eight-week period. Sleep data will be measured using sleep sensors for 9 weeks.
Interventions/Control_2
Sleep data will be measured using sleep sensors for 9 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Outpatients with heart failure
2.18 years of age or older
3.ISI-J score between 8 and 21
4.Have a Wi-Fi environment at home. Able to operate a smartphone or tablet
(Including cases where operation is possible with support from family members)
5.Physician has determined that the patient is able to participate in research
6.Able to communicate in Japanese
Key exclusion criteria
1.New York Heart Association functional classification, class IV
2.Diagnosed with sleep apnea syndrome or Epworth Sleepiness Scale score of 11 or higher
3.Suspected restless legs syndrome
4.Working in a shift work schedule
5.Under psychiatric treatment
6.Have started or changed sleeping medication in the past 3 months
7.Plans to receive new treatment for a coexisting condition during the study participation period
8.Cognitive impairment
9.Sleeping in the same bed with others
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Fukuda |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care / Graduate School of Health Management
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-2059
nfukuda@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | Michiyo |
| Middle name | |
| Last name | Takubo |
Organization
Keio University
Division name
Graduate School of Health Management
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-2059
Homepage URL
mtakubo@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2024 | Year | 08 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
IRB Approval: July 29, 2025 Protocol Revision 3 (June 5, 2025)
Management information
Registered date
| 2024 | Year | 08 | Month | 13 | Day |
Last modified on
| 2025 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062968
