UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037313 |
|---|---|
| Receipt number | R000042454 |
| Scientific Title | The effect of reflection on symptom management for older patients with heart failure living at home : A randomized controlled pilot study |
| Date of disclosure of the study information | 2019/07/10 |
| Last modified on | 2019/10/22 13:05:41 |
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Basic information
Public title
The effect of reflection on symptom management for older patients with heart failure living at home : A randomized controlled pilot study
Acronym
The effect of reflection on symptom management for older patients with heart failure living at home : A randomized controlled pilot study
Scientific Title
The effect of reflection on symptom management for older patients with heart failure living at home : A randomized controlled pilot study
Scientific Title:Acronym
The effect of reflection on symptom management for older patients with heart failure living at home : A randomized controlled pilot study
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.To develop an intervention program based on reflection to improve symptom managemet for older patients with heart failure living at home
2. To examine the effect of intervention program by pilot study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symptom perception and response to symptom
(One month after discharge from hospital)
Key secondary outcomes
Self-care (maintenance and confidence)
Depression
Anxiety
Perceived control
Health related quality of life
Heart failure-related and all-cause readmissions
Heart failure-related and all-cause unscheduled hospital visit
Adherence to use symptom diary
(One month after discharge from hospital)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
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
1.One session of counseling and education about symptom management based on reflection
(during hospitalization)
2.Provision of a symptom diary and education of how to use
3.Telephone follow-up at two weeks after discharge
Interventions/Control_2
One session of usual patient education
(during hospitalization)
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.Hospitalized with a primary diagnosis of heart failure exacerbation
2.New York Heart Association functional class II-IV
3.History of hospitalization due to heart failure
4.Planned discharge to home
5.A patient from whom informed consent of the participation in the study is obtained in written form
Key exclusion criteria
1.Cognitive impairment or psychiatric diagnosis that would affect their ability to participate in this study or provide informed consent
2.Physical impairments that would interfere with daily life
3.Heart failure secondary to acute coronary syndrome
4.Listed for an implanted ventricular assist device or heart transplant
5.Planned cardiac surgery or percutaneous coronary intervention
6.Visual or hearing impairment limiting the participation in this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Okada |
Organization
Graduate School of Kitasato University
Division name
Graduate School of Nursing
Zip code
252-0329
Address
2-1-1 Kitazato, Minamiku, Sagamihara, Kanagawa, Japan
TEL
042-778-9814
akiko.ok.0209@gmail.com
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Okada |
Organization
Graduate School of Kitasato University
Division name
Graduate School of Nursing
Zip code
252-0329
Address
2-1-1 Kitazato, Minamiku, Sagamihara, Kanagawa, Japan
TEL
042-778-9814
Homepage URL
akiko.ok.0209@gmail.com
Sponsor or person
Institute
Kitasato 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
Institutional Review Board of Kitasato University School of Nursing
Address
2-1-1 Kitazato, Minamiku, Sagamihara, Kanagawa, Japan
Tel
042-778-9281
nekosa@kitasato-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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 10 | 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
| 2019 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 09 | 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
| 2019 | Year | 07 | Month | 09 | Day |
Last modified on
| 2019 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042454
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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