UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032509 |
|---|---|
| Receipt number | R000037073 |
| Scientific Title | Effects of self-monitoring support using living activities record for patients with chronic heart failure early after hospital discharge |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2024/01/29 15:27:21 |
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Basic information
Public title
Effects of self-monitoring support using living activities record for patients with chronic heart failure early after hospital discharge
Acronym
Effects of self-monitoring support using living activities record for patients with chronic heart failure early after hospital discharge
Scientific Title
Effects of self-monitoring support using living activities record for patients with chronic heart failure early after hospital discharge
Scientific Title:Acronym
Effects of self-monitoring support using living activities record for patients with chronic heart failure early after hospital discharge
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the effects of self-monitoring support using objective living activities record for patients with chronic heart failure early after hospital discharge.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-care behavior
Key secondary outcomes
Self-monitoring
Health literacy
Physical activity
Clinical events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Self-monitoring support using objective living activities record
Interventions/Control_2
Explanation of the result of objective living activities record
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The patients who were admitted to hospital due to heart failure exacerbation and will go to each hospital
2) The patients older than 19 years old
3) The patients who were written informed consent obtained
Key exclusion criteria
1) The patients who can't walk indoors by themselves
2) The patients who have difficulty in answering Japanese questionnaire
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Ikuko |
| Middle name | |
| Last name | Miyawaki |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Nusing
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku, Kobe
TEL
078-796-4693
nsikuko@kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Ikuko |
| Middle name | |
| Last name | Miyawaki |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Nusing
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku, Kobe
TEL
078-796-4693
Homepage URL
nsikuko@kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science
YAMAJI FUMIKO NURSING RESEARCH FUND
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nishinomiya Watanabe Cardiovascular Center
Hyogo Prefectural Amagasaki General Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Health Sciences
Address
7-10-2 Tomogaoka, Suma-ku, Kobe
Tel
078-796-4502
syomu2@ams.kobe-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
西宮渡辺心臓・血管センター（兵庫県）
兵庫県立尼崎総合医療センター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
doi: 10.1016/j.conctc.2022.101017
Publication of results
Published
Result
URL related to results and publications
DOI: 10.1097/JCN.0000000000001058
Number of participants that the trial has enrolled
70
Results
There was no significant difference in the change in the "asking for help" of self-care behavior between the groups. Group A had improved score on the self-monitoring related to "concern about how movements affect body" from baseline. There was no significant effect of self-monitoring intervention support on the first rehospitalization related to HF and all-cause death. A significant difference in moderate intensity physical activity between the groups was observed.
Results date posted
| 2024 | Year | 01 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 11 | Month | 13 | Day |
Baseline Characteristics
Most of the participants were male (72.6%), and the median age of the sample was 71.5 years. A few participants (27.4%) had experienced prior hospitalization for HF.
Participant flow
Baseline assessment was conducted at the hospital discharge. All participants wore a Life Microscope wristwatch activity tracker with a triaxial accelerometer for 3-7 days, 24 hour per day except during water-related activities (e.g., bathing). Participants were randomly assigned to the intervention (received daily activity record-based self-monitoring intervention support, Group A) or control (only explained the measured results from the records, Group B) group. Group A reflected on and described the physical sensations in their daily activities within 1 month after discharge. Outcome measures were assessed at 1 month after the intervention. The clinical events and healthcare utilization during the 12 months after discharge were recorded from the medical records.
Adverse events
None.
Outcome measures
Self-care behavior, self-monitoring, physical activity and sleep, HF-related re-hospitalization and all-cause death.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | 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 | 05 | Month | 08 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037073
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