UMIN-CTR Clinical Trial

Basic information
Public title	Burden in quality of life (QOL), work productivity and healthcare cost for caregivers of patients with schizophrenia, depression, Alzheimer's disease, dementia and stroke
Acronym	Burden in quality of life (QOL), work productivity and healthcare cost for caregivers of patients with schizophrenia, depression, Alzheimer's disease, dementia and stroke
Scientific Title	Burden in quality of life (QOL), work productivity and healthcare cost for caregivers of patients with schizophrenia, depression, Alzheimer's disease, dementia and stroke
Scientific Title:Acronym	Burden in quality of life (QOL), work productivity and healthcare cost for caregivers of patients with schizophrenia, depression, Alzheimer's disease, dementia and stroke
Region	Japan

Condition
Condition	caregivers of patients with schizophrenia, depression, Alzheimer's disease, dementia and stroke
Classification by specialty	Neurology Psychiatry Neurosurgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Primary Objectives 1.Quantify and compare the health-related quality of life (HRQoL) and work productivity and activity impairment (WPAI) of caregivers of patients with schizophrenia, depression, Alzheimer's disease and dementia, and stroke, respectively, with non-caregivers in Japan 2.Quantify and compare the healthcare resource utilization (HRU), direct cost and indirect cost of caregivers of patients with schizophrenia, depression, Alzheimer's disease and dementia, and stroke, respectively, with non-caregivers in Japan 3.Quantify and compare the comorbid burden of depression measured by Patient Health Questionnaire-9 (PHQ-9) of caregivers of patients with schizophrenia, depression, Alzheimer's disease and dementia, and stroke, respectively, with non-caregivers in Japan
Basic objectives2	Others
Basic objectives -Others	Secondary Objectives 1. Quantify and compare the scores of the caregiver reaction assessment (CRA) among caregivers of patients with schizophrenia, depression, Alzheimer's disease and dementia, and stroke in Japan (all groups are compared to each other as pairwise comparison) 2. Quantify and compare the HRQoL, WPAI, HRU and costs among caregivers of patients with schizophrenia, depression, Alzheimer's disease and dementia, and stroke in Japan (all groups are compared to each other as pairwise comparison) 3. Quantify and compare the comorbid burden of depression measured by PHQ-9 among caregivers of patients with schizophrenia, depression, Alzheimer's disease and dementia, and stroke in Japan (all groups are compared to each other as pairwise comparison)
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Health outcomes: SF-12v2 PCS (Physical component summary) SF-12v2 MCS (Mental component summary) SF-6D index (SF-12v2) EQ-5D-5L Work Productivity and Activity Impairment (WPAI) Healthcare resource utilization (HRU) Patient Health Questionnaire-9 Caregiver reaction assessment (CRA) Costs
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	Respondents to the NHWS in 2016 and 2018, 18 years of age or older, self-reported caring for adults suffering from schizophrenia, depression, Alzheimer's disease, dementia and stroke. <Selection of non-caregivers> Respondents reported not caring for any adults suffering from any conditions were considered non-caregivers. A 1:1 propensity score matching process will be used to identify a control group of non-caregivers.
Key exclusion criteria	- Respondents who did not provide sufficient answers are excluded from the study. - For respondents who participated in both NHWS 2016 and 2018, only the most recent response (NHWS 2018) will be collected and the response from NHWS 2016 will be excluded.
Target sample size	50117

Research contact person
Name of lead principal investigator	1st name Lyo Middle name Last name Inuyama
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Medical Affairs Department
Zip code	1088242
Address	Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL	0367171400
Email	Inuyama.Lyo@otsuka.jp

Public contact
Name of contact person	1st name Yoshitsugu Middle name Last name Kojima
Organization	Otsuka Pharmaceutical Co., Ltd.
Division name	Medical Affairs Department
Zip code	1088242
Address	Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL	0367171400
Homepage URL
Email	kojimayo@otsuka.jp

Sponsor
Institute	Otsuka Pharmaceutical Co., Ltd. Medical Affairs Department
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The research ethics committee of Otsuka Pharmaceutical Co., Ltd
Address	463-10 Kagasuno,Kawauchi-cho,Tokushima-city,Tokushima
Tel	088-665-2126
Email	Imaizumi.Takashi@otsuka.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	2022 Year 09 Month 30 Day

Related information
URL releasing protocol	unpublished
Publication of results	Unpublished

Result
URL related to results and publications	unpublished
Number of participants that the trial has enrolled	50117
Results	The result showed that all caregiver groups had significantly higher CCI than non-caregivers. Caregivers of depression were younger, and a larger proportion of them were currently employed.
Results date posted	2022 Year 09 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	On average, caregivers of patients with Alzheimer's disease/dementia were oldest and caregivers of patients with depression were youngest (caregivers of Alzheimer's disease/dementia: 55.05; caregivers of depression: 45.45). Highest proportion of caregivers of Alzheimer's disease/dementia and lowest proportion of caregivers of schizophrenia were married/living with partner (caregivers of Alzheimer's disease/dementia: 69.6%; caregivers of schizophrenia: 56.3%) and completed university education (caregivers of Alzheimer's disease/dementia: 49.2%; caregivers of schizophrenia: 32.5%). Caregivers of depression had the highest proportion reported that they were currently employed (67.8%). All caregiver groups had higher CCI compared to non-caregivers, suggesting higher burden of comorbidities among caregivers. Lowest proportion of caregivers of schizophrenia had normal BMI (54.0%). Highest proportion of caregivers of depression were current smoker (24.0%). Highest proportion of caregivers of patients with Alzheimer's disease/dementia consumed alcohol at least 2 to 3 times per week (42.7%) and did at least 12 times of vigorous exercise in past 30 days (24.5%).
Participant flow	From the Japan NHWS database 2016 and 2018, a total of 126 caregivers of schizophrenia,146 caregivers of depression, 1,594 caregivers of Alzheimer's disease/dementia and 342 caregivers of stroke were included in the analyses and were compared to 47,909 non-caregivers.
Adverse events	NA
Outcome measures	Primary objectives: Health-Related Quality of Life In the bivariate analysis, caregivers of schizophrenia had significantly lower PCS, EQ-5D index and SF-6D, compared to the non-caregivers. However, the difference in MCS was not statistically significant. Work Productivity and Activity Impairment In the bivariate analysis, caregivers of schizophrenia had significantly greater total work productivity and total activity impairment. Although caregivers of schizophrenia had much higher means in absenteeism and presenteeism than non-caregivers, the differences were not statistically significant. The small sample size can be a potential reason for this. Healthcare resource utilization and Costs In the bivariate analysis, caregivers of schizophrenia had significantly more ER visits in the past 6 months, higher presenteeism cost and indirect cost. PHQ-9 In the bivariate analysis, no difference was identified in PHQ-9 between caregivers of schizophrenia and non-caregivers.
Plan to share IPD	None
IPD sharing Plan description	None

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 11 Month 25 Day
Date of IRB	2020 Year 11 Month 25 Day
Anticipated trial start date	2021 Year 01 Month 21 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a cross-sectional study using NHWS self-reported data (2016 and 2018). Only caregivers who cared for patients with only one targeted disease were included in the analysis.

Management information
Registered date	2022 Year 09 Month 27 Day
Last modified on	2022 Year 09 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055769