UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052236 |
|---|---|
| Receipt number | R000059625 |
| Scientific Title | Validation of the Effectiveness of Self-Monitoring Education by Visiting Nurses for Improving Health Literacy in Elderly Individuals with Chronic Illnesses Receiving Home Care |
| Date of disclosure of the study information | 2023/09/20 |
| Last modified on | 2025/02/19 14:52:05 |
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Basic information
Public title
Effectiveness evaluation of health literacy education provided by visiting nurses to elderly individuals with chronic illnesses.
Acronym
Effectiveness evaluation of health literacy education provided by visiting nurses to elderly individuals with chronic illnesses.
Scientific Title
Validation of the Effectiveness of Self-Monitoring Education by Visiting Nurses for Improving Health Literacy in Elderly Individuals with Chronic Illnesses Receiving Home Care
Scientific Title:Acronym
Validation of the Effectiveness of Self-Monitoring Education by Visiting Nurses for Improving Health Literacy in Elderly Individuals with Chronic Illnesses Receiving Home Care
Region
| Japan |
Condition
Condition
chronic physicial illnesses.
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to create a health literacy education program utilizing self-monitoring conducted by visiting nurses for elderly individuals with chronic illnesses receiving home care, and to validate its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health Literacy:Functional Communicative and Critical Health Literacy Scale
Key secondary outcomes
MOS 12Item Short Form Health Survey(SF 12v2)
Morisky Medication Adherence Scale-8 Japanese version
The Dietary variety score
Hospitalization occurrence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
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
In the intervention group, watching video content related to health literacy, confirming it through workbooks, and conducting it once a week for three weeks.
Interventions/Control_2
In the control group, usual care provided by regular visiting nurses65
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
Individuals with chronic illnesses receiving home-based care
Key exclusion criteria
Individuals with dementia, those in end-of-life conditions, or individuals with limitations in reading materials used for interventions or communication during the study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazuko |
| Middle name | |
| Last name | Maruyama |
Organization
Osaka City University
Division name
School of Nursing
Zip code
545-0051
Address
1-5-17 Asahi,Abeno,Osaka
TEL
06-6645-3511
d21na002@st.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Maruyama |
Organization
Osaka City University
Division name
School of Nursing
Zip code
545-0051
Address
1-5-17 Asahi,Abeno,Osaka
TEL
06-6645-3511
Homepage URL
d21na002@st.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Sasakawa Health Fundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University
Address
1-5-17 Asahi,Abeno,Osaka
Tel
06-6645-3511
d21na002@st.osaka-cu.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
| 2023 | Year | 09 | Month | 20 | 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
92
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 | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059625
