UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045252 |
|---|---|
| Receipt number | R000051503 |
| Scientific Title | Web-based questionnaire survey on heart failure in elderly patients using outpatient rehabilitation |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2023/12/13 00:43:37 |
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Basic information
Public title
Web-based questionnaire survey on heart failure in elderly patients using outpatient rehabilitation
Acronym
Web-based questionnaire survey on heart failure in elderly patients using outpatient rehabilitation
Scientific Title
Web-based questionnaire survey on heart failure in elderly patients using outpatient rehabilitation
Scientific Title:Acronym
Web-based questionnaire survey on heart failure in elderly patients using outpatient rehabilitation
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology | Geriatrics | Cardiovascular surgery |
| Rehabilitation medicine | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this survey is to clarify in outpatient rehabilitation facilities as follow: 1) the reality of rehabilitation content and risk management including lifestyle issues from the facilities accepting heart failure in elderly patients, and, 2) the reasons for not accepting heart failure in elderly patients from the facilities not accepting them.
Basic objectives2
Others
Basic objectives -Others
Factual Research
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rehabilitation content and risk management of heart failure in elderly patients
Key secondary outcomes
1)Disease management and problems in elderly patients with heart failure
2)Content of the medical information form required by medical institutions
3)Necessity of cardiac rehabilitation and heart failure treatment support in outpatient rehabilitation
4)The reasons for not accepting heart failure in elderly patients
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Preventive - and outpatient rehabilitation facilities in the Kansai area (6 prefectures) that respond to the web-based questionnaire
Key exclusion criteria
None
Target sample size
1258
Research contact person
Name of lead principal investigator
| 1st name | Rie |
| Middle name | |
| Last name | Sakamoto |
Organization
Hyogo College of Medicine Sasayama Medical Center
Division name
Department of Rehabilitation
Zip code
669-2321
Address
5 Kurooka, Tanbasasayama, Hyogo 669-2321, Japan
TEL
079-552-7381
rie-saka@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Tauchi |
Organization
Hyogo College of Medicine Sasayama Medical Center
Division name
Department of Rehabilitation
Zip code
669-2321
Address
5 Kurooka, Tanbasasayama, Hyogo 669-2321, Japan
TEL
079-552-7381
Homepage URL
tau24@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osakagasgroup Welfare Foundation
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
Hyogo College of Medicine
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan
Tel
0798-45-6111
rinri@hyo-med.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
兵庫医科大学ささやま医療センター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/circrep/5/4/5_CR-22-0102/_article/-char/ja/
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circrep/5/4/5_CR-22-0102/_article/-char/ja/
Number of participants that the trial has enrolled
184
Results
Facilities treating patients with HF generally provided exercise therapy, patient education, and disease management, which were components of CR. Many facilities not currently treating patients with HF responded positively stating they will accept HF patients in the future. However, a few facilities responded by stating that they are waiting for clearer evidence demonstrating the beneficial effect of OR on patients with HF.
Results date posted
| 2023 | Year | 12 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This survey was a cross-sectional self-reported web-based questionnaire. Participating OR facilities were selected in the Kansai region using purposive sampling. Inclusion criteria included 1,258 OR facilities that were registered with Ministry of Health, Labour and Welfare publication system for long-term care service information17 in the Kansai region (6 prefectures: Hyogo, Osaka, Kyoto, Wakayama, Shiga, Nara) of Japan as of July 1, 2021.
Participant flow
The survey description, including a link to the web-based questionnaire, could only be sent to 1,242 facilities due to 16 exclusions, 3 of which were duplicate registrations and 13 returns (11 with no fixed address and 2 with a suspension of business). The response rate of the web-based questionnaire was 14.8% (184 facilities). Of the 184 facilities, 159 (86.4%) accepted patients with HF.
Adverse events
Nothing
Outcome measures
Content of rehabilitation programs, risk management, exercise load and lifestyle guidance(all facilities)
Reasons for difficulty in accepting patients with HF (non-accepting facilities only)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 03 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
A cross sectional web-based survey
Statistical Analysis:
･The outpatient rehabilitation facilities characteristics were calculated for categorical variables.
･Nonparametric statistics
･The associations between rehabilitation content and risk management in accepting and non-accepting facilities of the heart failure in elderly patients were analyzed using a chi-square test and fisher's exact test).
･Conduct correspondence analysis and cluster analysis as necessary.
･Free-text comments will be subject to text mining analysis as necessary.
Statistical software:
JMPpro15, R3.5.1, HADver16, HK Coder 3
Management information
Registered date
| 2021 | Year | 08 | Month | 24 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051503
