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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032301
Receipt No. R000036838
Scientific Title Cross-sectional survey on insomnia and caregiver burden in Alzheimer's disease
Date of disclosure of the study information 2018/04/18
Last modified on 2019/08/05

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Basic information
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
Condition Insomnia with Alzheimer's disease
Classification by specialty
Neurology Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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.

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 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

Research contact person
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

Public contact
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

Sponsor
Institute MSD K.K.
Institute
Department

Funding Source
Organization MSD K.K.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
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
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
2018 Year 04 Month 18 Day

Related information
URL releasing protocol https://doi.org/10.1007/s00415-019-09286-0
Publication of results Published

Result
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

Progress
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
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.

Management information
Registered date
2018 Year 04 Month 18 Day
Last modified on
2019 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036838

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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