DementiaNCT03724344
Correlation Study Between Mental Behavioral Symptoms in Dementia Patients and Mood Disorders of Caregivers
An observational study of Dementia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Traditionally, the more severity of dementia patients, the heavier the burden of the comparators, and in the clinical observation,the dementia patients with rich mental behavior symptoms are more burdened. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Cross section resaerch
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2017to 30 Sep 2020
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Outpatients and community dementia patients and their primary caregivers
Who may be able to join
- Age is greater than 18 years old, gender is not limited
- Comply with ICD-10 diagnostic criteria, diagnosed with dementia, including Alzheimer's disease, vascular dementia, frontotemporal dementia, dementia with Lewy body, dementia caused by Parkinson's disease
Who cannot join
- senile schizophrenia;
- senile depression;
- cognitive impairment caused by endocrine system diseases (such as decreased thyroid and adrenal function);
- Cognitive impairment or dementia caused by serious diseases such as cardiovascular, lung, liver, kidney, and hematopoietic system;
- Cognitive impairment or dementia caused by alcohol, drug use, psychotropic drugs; 6）Other physical or chemical factors that cause cognitive impairment or dementia-
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huangpu District Mental Health Center
Shanghai, Shanghai Municipality, 20000
Jing Ni, Doctor
About this study
Official title: Correlation Analysis Between Mental Behavioral Symptoms in Dementia Patients and Mood Disorders of Caregivers
Traditionally, the more severity of dementia patients, the heavier the burden of the comparators, and in the clinical observation,the dementia patients with rich mental behavior symptoms are more burdened. Therefore, exploring the impact of psychological burden and different subtypes of different dimensions with Behavioral and psychological symptoms (BPSD) will more comprehensive understanding of the factors affecting the burden of caregivers.
The starting point of this project is to analyze the relationship between the types of mental behavior symptoms of dementia patients and the emotional disorders of caregivers. The topic will analyze the correlation of psychological burden of caregivers and different symptom dimensions from the perspective of refinement, helping more effective identifying high-burden mental behavior symptoms in clinically , judging the risk of emotional problems in caregivers, and adopting better humanities or medical care, so that dementia patients can better adapt to care and improve the mental health of caregivers.
- Conditions
- Dementia
- Being tested
- Cross section resaerch
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross section resaerchOther
Assessment of cognitive (MoCA), mental behavioral symptoms (NPI） the Self-rating Depression Scale (SDS) and the Self-rating Anxiety Scale (SAS).
| Study group | Role | What they receive |
|---|---|---|
| Dimensions with Behavioral and psychological symptoms | Not described Receives: Other: Cross section resaerch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychiatric inventory questionnaire
Behavioral and psychological symptoms
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start20 Oct 2017
- Primary completion31 Aug 2019 (estimated)
- Study completion30 Sep 2020 (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 Shanghai Mental Health CenterThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenghui Yi, MD, Study chair, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724344
- Sponsor's protocol ID
- HKM201721
- Status last verified
- Oct 2017
- First submitted
- 27 Oct 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Analysis Between Mental Behavioral Symptoms in Dementia Patients and Mood Disorders of Caregivers
- ClinicalTrials.gov ID
- NCT03724344
- Acronym / sponsor ID
- HKM201721
- Conditions
- Dementia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 30 Oct 2018 (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.
Traditionally, the more severity of dementia patients, the heavier the burden of the comparators, and in the clinical observation,the dementia patients with rich mental behavior symptoms are more burdened. Therefore, exploring the impact of psychological burden and different subtypes of different dimensions with Behavioral and psychological symptoms (BPSD) will more comprehensive understanding of the factors affecting the burden of caregivers.
The starting point of this project is to analyze the relationship between the types of mental behavior symptoms of dementia patients and the emotional disorders of caregivers. The topic will analyze the correlation of psychological burden of caregivers and different symptom dimensions from the perspective of refinement, helping more effective identifying high-burden mental behavior symptoms in clinically , judging the risk of emotional problems in caregivers, and adopting better humanities or medical care, so that dementia patients can better adapt to care and improve the mental health of caregivers.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dimensions with Behavioral and psychological symptoms | – | Other: Cross section resaerch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Outpatients and community dementia patients and their primary caregivers
Key inclusion criteria (2 listed)
- Age is greater than 18 years old, gender is not limited
- Comply with ICD-10 diagnostic criteria, diagnosed with dementia, including Alzheimer's disease, vascular dementia, frontotemporal dementia, dementia with Lewy body, dementia caused by Parkinson's disease
Key exclusion criteria (5 listed)
- senile schizophrenia;
- senile depression;
- cognitive impairment caused by endocrine system diseases (such as decreased thyroid and adrenal function);
- Cognitive impairment or dementia caused by serious diseases such as cardiovascular, lung, liver, kidney, and hematopoietic system;
- Cognitive impairment or dementia caused by alcohol, drug use, psychotropic drugs; 6）Other physical or chemical factors that cause cognitive impairment or dementia-
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 |
|---|---|---|
| Cross section resaerchAssessment of cognitive (MoCA), mental behavioral symptoms (NPI） the Self-rating Depression Scale (SDS) and the Self-rating Anxiety Scale (SAS). | Other | Dimensions with Behavioral and psychological symptoms |
Primary outcome
Neuropsychiatric inventory questionnaire
Time frame: baseline
Behavioral and psychological symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Zhenghui Yi, MD study chair
Shanghai Mental Health Center
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 Shanghai Mental Health Center at 1 site in China.
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 2 inclusion and 5 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 30 Oct 2018. 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 China. 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 Jing Ni, Doctor (08613564638852, jwzxnj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychiatric inventory questionnaire (time frame: baseline). 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 30 Oct 2018.