DementiaNCT06301269
A Study on Self-Compassion,Depression,and Quality of Life Among Primary Caregivers of People With Dementia
An observational study of Dementia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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: 1. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Mar 2024to 30 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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).
Who may be able to join
- primary caregivers of dementia patients diagnosed by specialists
- aged 18 and above
- who spend 8 hours or more daily (including overnight caregivers) providing care
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
wen lin YE, +886-2312-3456, vovo951357@ntuh.gov.tw
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Dementia
- Keywords
- dementia, self-compassion, Primary Caregivers
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: The participants will spend 5-10 minutes completing the questionnaire during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start10 Mar 2024 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301269
- Sponsor's protocol ID
- 202312124RINA
- Status last verified
- Mar 2024
- First submitted
- 3 Mar 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Self-Compassion,Depression,and Quality of Life Among Primary Caregivers of People With Dementia
- ClinicalTrials.gov ID
- NCT06301269
- Acronym / sponsor ID
- 202312124RINA
- Conditions
- Dementia
- Keywords
- dementia, self-compassion, Primary Caregivers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Mar 2024 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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).
Key inclusion criteria (3 listed)
- primary caregivers of dementia patients diagnosed by specialists
- aged 18 and above
- who spend 8 hours or more daily (including overnight caregivers) providing care
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | – |
Primary outcome
Self-Compassion Scale
Time frame: The participants will spend 5-10 minutes completing the questionnaire during the study
The self-compassion score, measured using the Self-Compassion Scale, reflects the level of self-compassion among primary caregivers of people with dementia.
PHQ-9 Scale
Time frame: The participants will spend 5-10 minutes completing the questionnaire during the study
The PHQ-9 Scale, measured using the PHQ-9 Scale, reflects the level of depression among primary caregivers of people with dementia.
Quality-of-Life Scale
Time frame: The participants will spend 5-10 minutes completing the questionnaire during the study
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen Lin Ye (02-2312 3456 ext. 262788, vovo951357@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Compassion Scale (time frame: The participants will spend 5-10 minutes completing the questionnaire during the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.