UMIN-CTR Clinical Trial

Public title

Cross-sectional survey on insomnia and caregiver burden in Alzheimer's disease

Acronym

Cross-sectional survey on insomnia and caregiver burden in Alzheimer's disease

Scientific Title

Cross-sectional survey on insomnia and caregiver burden in Alzheimer's disease

Scientific Title:Acronym

Cross-sectional survey on insomnia and caregiver burden in Alzheimer's disease

Region

Japan

Condition

Insomnia with Alzheimer's disease

Classification by specialty

Neurology	Geriatrics	Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To determine the impact of sleep disturbance of patients with Alzheimer's disease (AD) on the burden to their caregivers.

Basic objectives2

Others

Basic objectives -Others

To assess correlation between caregiver burden as measured by BIC-11 and patients sleep as measured by SDI in AD.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Correlation between caregiver burden as measured by BIC-11 and patients sleep as measured by SDI in AD.

Key secondary outcomes

- Correlation between caregiver sleep as measured by PSQI and patients sleep as measured by SDI in AD.
- Correlation between caregiver QOL as measured by SF-12 and patients sleep as measured by SDI in AD.
- Correlation between caregiver depression (PHQ-9:>=10) and patients sleep as measured by SDI in AD.
- Correlation between caregiver time spent in patients care and patients sleep as measured by SDI in AD.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Age 20 years old or older
2) Informal caregivers of mild to moderate AD patients with experience of insomnia symptom in Japan, who are living with the patients.
3) A primary caregiver, if care responsibilities are shared with another person.

Key exclusion criteria

1) A caregiver of two or more persons.
2) A caregiver with schizophrenia, depression or bipolar disorder diagnosed by a doctor
3) A caregiver of the following patient
- Patients with mental disorder, or mental retardation
- Patients with dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, Parkinson's disease, sleep apnea using CPAP or BIPAP.
- Patients with physical disabilities by injury or congenital abnormality (upper or lower limb loss/impairment (including bone fracture), visual impairment, hearing loss etc.) which require someone's help

Target sample size

500

Name of lead principal investigator

1st name	Shoki
Middle name
Last name	Okuda

Organization

MSD K.K.

Division name

Medical Affairs

Zip code

102-8667

Address

1-13-12 Kudan-kita, Chiyoda-ku, Tokyo

TEL

03-6272-1067

Email

ldgproject@merck.com

Name of contact person

1st name	Shoki
Middle name
Last name	Okuda

Organization

MSD K.K.

Division name

Medical Affairs

Zip code

102-8667

Address

1-13-12 Kudan-kita, Chiyoda-ku, Tokyo

TEL

03-6272-1067

Homepage URL

Email

ldgproject@merck.com

Institute

MSD K.K.

Institute

Department

Personal name

Organization

MSD K.K.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

NPO Clinical Research Enhancement Network Japan

Address

1-4-9 Itachibori, Nishi-ku, Osaka-shi, Osaka

Tel

06-4393-8403

Email

osaka@sct-net.org

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

2018

Year

04

Month

18

Day

URL releasing protocol

https://doi.org/10.1007/s00415-019-09286-0

Publication of results

Published

URL related to results and publications

https://doi.org/10.1007/s00415-019-09286-0

Number of participants that the trial has enrolled

500

Results

We found that the BIC-11 total score increased as the SDI score increased, indicating a significant positive association, even after adjusting for confounding factors. Similar patterns were observed for subdomain of BIC-11 (time-dependent, emotional, existential, physical, service-related, and total care burdens). We also found an association between sleep disturbances of AD patients and health of caregivers.

Results date posted

2019

Year

08

Month

05

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

AD patients:
The proportion of males to females was 27.8% and 72.2%, respectively. The mean age of the total population was 82.8 years, and those aged 75 years or older accounted for 83.9%. The severity of AD was mild in 35.7% and moderate in 64.3% and the duration of AD was 4.04 years.
Caregivers:
The proportion of male to female was 49.8% and 50.2%, respectively. The mean age of the total population was 50.4 years. Caregivers aged 20-39 years and 40-64 years accounted for 21.2% and 69.6% of participants, respectively. The most common relationship to the patient was daughter or son (81.3%).

Participant flow

The participants will be recruited from a web panel of general population. Of 3,416,514 candidates, 399,917 responded to the invitation to participate. Eligible responses were obtained from 500 participants (250 men and 250 women). Four participants were excluded, leaving 496 for analysis.

Adverse events

Not reported.

Outcome measures

Primary outcome:
- Correlation between caregiver burden as measured by BIC-11 and patients sleep as measured by SDI in AD.
Secondary outcome:
- Correlation between caregiver sleep as measured by PSQI and patients sleep as measured by SDI in AD.
- Correlation between caregiver QOL as measured by SF-12 and patients sleep as measured by SDI in AD.
- Correlation between caregiver depression measured by PHQ-9 and patients sleep as measured by SDI in AD.
The detail is described in the reprort (Okuda et al. (2019) J Neurol 266:1490-1500).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2018

Year

02

Month

06

Day

Date of IRB

2018

Year

02

Month

22

Day

Anticipated trial start date

2018

Year

04

Month

19

Day

Last follow-up date

2018

Year

06

Month

18

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a cross-sectional survey of caregivers of AD patients. The participants will be recruited from a web panel of general population. A web survey questionnaire will be sent to estimated 300 thousand people selected from the panel in order to obtain 500 eligible respondents who complete the survey. The participants will be asked to answer screening questions, and only eligible respondents will be asked to answer further questionnaires to complete the survey.
The survey will collect information on caregivers and their patients demographics, caregivers burden by using BIC-11 (Burden Index of Caregivers-11), caregivers sleep quality by using Pittsburgh Sleep Quality Index (PSQI), caregivers QOL by using SF-12, time spent in informal care (hrs/day), patients sleep by using SDI (Sleep Disorder Inventory), and patients neuropsychiatric symptoms by using Neuropsychiatric Inventory-Brief Questionnaire Form (NPI-Q).
An approval from an institutional review board to conduct the study will be obtained.

Registered date

2018

Year

04

Month

18

Day

Last modified on

2019

Year

08

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036838