UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056282 |
|---|---|
| Receipt number | R000059945 |
| Scientific Title | Comprehensive exploration for patterns of multimorbidity and health-related outcomes in home care patients |
| Date of disclosure of the study information | 2024/11/27 |
| Last modified on | 2025/11/28 10:12:09 |
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Basic information
Public title
Comprehensive exploration for patterns of multimorbidity and health-related outcomes in home care patients
Acronym
Multimorbidity and health-related outcomes in home care patients
Scientific Title
Comprehensive exploration for patterns of multimorbidity and health-related outcomes in home care patients
Scientific Title:Acronym
Multimorbidity and health-related outcomes in home care patients
Region
| Japan |
Condition
Condition
multimorbidity
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main objective of this study is to analyze and describe the disease patterns of patients with multimorbidity receiving home care.
Basic objectives2
Others
Basic objectives -Others
We will clarify the association between the quality of multidisciplinary care and the quality of life of patients and their family caregivers, as well as the association between the complexity of prescriptions, adherence to medication, and caregivers' attitudes toward medication burden and deprescribing.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Quality of life of patients with multimorbidity receiving home care and their family caregivers.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients over 18 years old
Patients who are receiving home care to their own home
Key exclusion criteria
Patients who newly started home care in February 2024 or later
Residents of institutional facilities
If the patient does not agree to participate in the study
Patients whose physical symptoms are unstable or whose prognosis is limited, and whose responses are judged to be psychologically or physically burdensome.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Shoichi |
| Middle name | |
| Last name | Masumoto |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
0298533189
smash422@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Shoichi |
| Middle name | |
| Last name | Masumoto |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
0298533189
Homepage URL
smash422@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research Japan society of the promotion of science
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
Ethics committee of the Institute of Medicine, University of Tsukuba
Address
1-1-1, Tennnodai, Tsukuba, Ibaraki, Japan
Tel
0298533189
smash422@md.tsukuba.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 | 11 | Month | 27 | 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
Among home-care patients, 96.4% had two or more comorbidities, and 84.8% had three or more comorbidities.
Results date posted
| 2025 | Year | 11 | Month | 28 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Delay of analysis
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data collection items:
Physician-in-charge evaluation items (extract the situation at the most recent clinic visit)
-Patient's age, gender
-Diseases, Type of medical treatment, Average time of visit, Level of care required, ADL (Clinical Frailty Scale)
-Cognitive function (level of independence in daily living for the elderly with dementia)
-Number of monthly home visits (once, twice, three or more times)
-Number of home visits per month (once, twice, three or more times)
-Difficulties with medical treatment, Prescription drugs
-Use of home nursing care
Questionnaire survey of the patient
-Quality of Life (QOL-HC)
-Attitude toward deprescribing (using one question from the PATD)
-Burden of taking medications (using the item on difficulty in taking medications in the MTBQ)
-Medication adherence (Ueno et al. scale)
-Patient experience (JPCAT-SF)
Questionnaire survey of family caregivers
-Characteristics of family caregivers: age, gender, relationship with patient, caregiving time, educational background, annual household income
-J-IEXPAC CAREGIVERS
-Time of certification as requiring care, medical care environment prior to introduction of home-visit care
-Services used (home nursing, home pharmaceuticals, home care, etc.)
-Burden of caregiving (BIC-11)
-Caregiver QOL (ASCOT Carer)
-Pharmacy manager (patient/caregiver)
-Caregiver Perceived Burden of Medication (using MTBQ items on medication)
-Attitude toward deprescribing (using one question from the rPATD)
Management information
Registered date
| 2024 | Year | 11 | Month | 27 | Day |
Last modified on
| 2025 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059945
