UMIN-ICDS Clinical Trial

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

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

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Otsuka Pharmaceutical Co., Ltd.
Medical Affairs Department

Institute

Department

Personal name

Organization

Otsuka Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

09

Month

30

Day

URL releasing protocol

unpublished

Publication of results

Unpublished

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

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 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.

Registered date

2022

Year

09

Month

27

Day

Last modified on

2022

Year

09

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055769