A Study on Self-Compassion,Depression,and Quality of Life... | NCT06301269

Studies
A Study on Self-Compassion,Depression,and Quality of Life Among Primary Caregivers of People With Dementia

NCT06301269

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Mar 8, 2024Actual

Enrollment

160Estimated

Phase

Not provided

Conditions

Dementia

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2024Estimated

Primary Completion Date

May 30, 2024Estimated

Completion Date

Jul 30, 2024Estimated

First Submitted Date

Mar 3, 2024

First Submission Date that Met QC Criteria

Mar 3, 2024

First Posted Date

Mar 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2024

Last Update Posted Date

Mar 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to investigate the correlation between self-compassion, depression, and quality of life among primary caregivers of persons with dementia.

The main questions it aims to answer are:

What is the current status of self-compassion, depression, and quality of life among primary caregivers of persons with dementia?
Are there differences in self-compassion, depression, and quality of life among primary caregivers of persons with dementia based on different background variables?
What is the correlation between self-compassion, depression, and quality of life among primary caregivers of persons with dementia?

Participants will fill out the questionnaire to complete the study.

Detailed Description

The study design of this research is cross-sectional. The participants are primary caregivers of dementia patients diagnosed by specialists, aged 18 and above, who spend 8 hours or more daily (including overnight caregivers) providing care. Data is collected using instruments including the Self-Compassion Scale, the PHQ-9 Scale (Patient Health Questionnaire,PHQ-9）, and the Quality-of-Life Scale to investigate the relationship between self-compassion, depression, and quality of life among primary caregivers of dementia patients.

The study uses independent samples t-tests and one-way ANOVA( analysis of variance,ANOVA) to explore differences in self-compassion, depression, and quality of life among primary caregivers of dementia patients based on different background variables. Pearson correlation is used to analyze the relationships between these variables. Finally, linear regression is used to predict the performance of primary caregivers of dementia patients in self-compassion, depression, and quality of life.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Name	Type	Description	Arm Group Labels	Other Names
	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self-Compassion Scale	The self-compassion score, measured using the Self-Compassion Scale, reflects the level of self-compassion among primary caregivers of people with dementia.	The participants will spend 5-10 minutes completing the questionnaire during the study
PHQ-9 Scale	The PHQ-9 Scale, measured using the PHQ-9 Scale, reflects the level of depression among primary caregivers of people with dementia.	The participants will spend 5-10 minutes completing the questionnaire during the study
Quality-of-Life Scale	The Quality-of-Life Scale , measured using the Quality-of-Life Scale , reflects the level of Quality-of-Life among primary caregivers of people with dementia.	The participants will spend 5-10 minutes completing the questionnaire during the study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primary caregivers of dementia patients diagnosed by specialists
aged 18 and above
who spend 8 hours or more daily (including overnight caregivers) providing care

Exclusion Criteria:

Those who do not agree to participate in the research
Caregivers in a paid relationship with dementia patients, such as foreign domestic helpers and government-provided resident care attendant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

The study will include primary caregivers of people with dementia. Participants will be adults aged 18 years and older who are currently providing care for a family member , Participants will be recruited from NTUH Neurology ward and Out-Patient Departments (OPD).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wen Lin Ye	Contact	02-2312 3456	262788	vovo951357@ntuh.gov.tw

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D003704	Dementia

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019965	Neurocognitive Disorders

Browse Leaves

Not provided

Browse Branches

Not provided