Advanced DementiaPISCESNCT03382223

Panel Study Investigating Status of Cognitively Impaired Elderly in Singapore

An observational study of Advanced Dementia, run by Duke-NUS Graduate Medical School at 9 sites in Singapore.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Advanced Dementia
How many people: 400 participants
Where: 9 sitesSingapore
Study dates: 8 May 2018to Dec 2026
Phase: Observational
Are there results?: Not yet: the study is under way

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 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: This is a prospective study of primary informal caregivers of 400 patients dying with severe dementia (PDSD) who will be surveyed every 4 months for a period of 2 years or until the patient passes away and then post-death 6 weeks and 6 months to assess bereavement of the caregiver. Treating physicians of the patients will also be invited to take part in the study.

Who may be able to join

Age ≥ 21 years old
Singaporean/Singapore Permanent Resident
Intact cognition determined through the Abbreviated Mental Test (AMT) for those who are ≥ 65 years old
Patients who score 20 or more on QDRS answered by caregivers will be considered to have severe dementia
Main person or one of the main persons providing care to patient (e.g. accompanying patient for doctor's visits, helping patient with day to day activities)
Main person or one of the main persons ensuring the provision of care to patient (e.g. supervision of foreign domestic worker so that patient is looked after)
Main person or one of the main persons involved in making decisions regarding treatment patient receives
Caregivers of patients they are treating are enrolled in the study

Who cannot join

Caregivers ≥ 65 years old with cognitive impairment or serious mental illness determined through AMT
Foreign domestic workers/maids

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Singapore9 sites

Tsao Foundation
Singapore, 168730
Singapore General Hospital
Singapore, 169608
Alzheimer's Disease Association
Singapore, 339940
Care for the Elderly Foundation
Singapore, 427411
Changi General Hospital
Singapore, 529889
Institute of Mental Health
Singapore, 539747
Jurong Community Hospital
Singapore, 609606
St. Luke's Hospital
Singapore, 659674
Khoo Teck Puat Hospital
Singapore, 768828

Other trials in Singapore

About this study

Dementia affects 10% of the elderly population in Singapore. However, there is a lack of systematic information regarding end of life (EOL) care received by patients dying with severe dementia (PDSD), PDSD's EOL direct and indirect costs and caregiver burden. This study, a first of-its-kind prospective cohort study in Singapore will assess the EOL care received by PDSD and PDSD's caregivers, EOL medical and social care costs of severe dementia and caregiver burden; and will develop a risk score to predict 6-month mortality for PDSD. The investigators will accomplish this by surveying caregivers of PDSD every 4 months till the patient passes away and 6 weeks and 6 months after patient's death during caregiver bereavement. The investigators will also extract and match patient medical and billing data with survey data for comprehensive assessment of care costs.

Key outcomes achieved by this study will be improved understanding of PDSD's EOL care, EOL care costs, and caregiver burden and bereavement. The systematic data collected will also lead to predicting 6 month mortality for community dwelling PDSD with greater accuracy compared to existing tools. Positive implications from this study will be improved early decision making by caregivers regarding EOL care and physician referrals for palliative care services; and a better understanding of EOL care for PDSD and PDSD's caregivers that will lead to cross-sector collaborations to improve delivery of palliative care to PDSD. In this way this proposal is highly responsive to the grant call which focuses on early decision making and cross sector palliative care delivery among non-cancer patients. In the long term, this study will improve clinical and public health policy and has the potential to be the foundation for future initiatives for dementia care and improved social and medical infrastructure planning.

Conditions: Advanced Dementia

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in quality of life of patient
We will assess the quality of life of patient by asking caregivers the list of comorbidities and acute medical conditions that patient has, patient's experience of symptoms, patient's functional status and behaviours that patient exhibits.
Measured: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
Change in quality of care received by patient
We will assess the quality of care received by patient by asking the caregiver of any use of tube-feeding, physical restraint and other medical interventions; as well as checking with the caregiver if they are satisfied with the care provided for patient.
Measured: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
Change in caregiver's resilience
We will assess caregiver's resilience through the abbreviated version of the Connor-Davidson Resilience Scale (CD-RISC), the CD-RISC 2. Only 2 items will be adapted from CD-RISC. For each item, it is rated on a 5-point scale, ranging from 0 to 4 as follows: "not true at all", "rarely true", "sometimes true", "often true" and "true nearly all of the time", with higher scores reflecting greater resilience.
Measured: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
Change in caregiver burden
We will assess caregiver burden through modified Caregiver Reaction Assessment (CRA) Instrument. This instrument captures 5 domains of caregiver reaction and we adopted 4 out of the 5 domains. Each item is scored on a five-point likert scale, ranging from 0 to 4 as follows: "strongly disagree", "disagree", "neither agree nor disagree", "agree" and "strongly agree". We amended and included "not applicable" to the scale as well. The items constituting a particular domain are averaged to generate subscale scores. A higher score on the subscales indicate greater negative effects of caregiving in those domains.
Measured: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
Change in caregiver's ability to cope
We will assess caregiver's ability to cope through the BriefCOPE instrument. This instrument measures 14 conceptually differentiable coping reactions; each of which comprises of 2 subscales. The scale ranges from 0 to 3 as follows: "I haven't been doing this at all", "I've been doing this a little bit", "I've been doing this a medium amount" and "I've been doing this a lot". This measure does not compute the overall score. The scales are analysed separately to see what its relation is to other variables.
Measured: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
Change in caregiver's levels of emotional distress
We will assess caregiver's anxiety and depression through the Hospital Anxiety and Depression Scale (HADS). The instrument comprises seven questions for anxiety and seven questions for depression. Each item comprises of a four point (0-3) response category. Hence the possible score ranges from 0 to 21 for anxiety and for depression. A score of 0 to 7 for either subscale is regarded as being in the normal range, a score of 11 or higher indicates probable presence of mood disorder and a score of 8 to 10 is suggestive of the presence of the respective state.
Measured: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
Change in caregiver's awareness of prognostic information
We will assess preferences of caregivers for the disclosure of prognostic information of patient.
Measured: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
Change in caregiver's grief experience
We will assess caregiver's grief experience through the MM Caregiver Grief Inventory- Short Form (MM-CGI-SF). The instrument consists of 3 domains (each domain has 6 items) with a total of 18 items. For each item, the scale ranges from 1 to 5 as follows: "strongly disagree", "disagree", "somewhat agree", "agree" and "strongly agree". The subscale is computed by summing up the scores of the 6 items for each domain. Higher scores may indicate a need for formal intervention or support assistance to enhance coping, while lower scores may indicate denial or a downplaying of distress or positive adaptation if the individual is not showing other signs of suppressed grief. The total grief level is computed by summing up the scores for the 18 items.The higher the score, the greater the level of grief experienced by the caregiver, vice versa.
Measured: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
Change in resource utilisation for patient
We will assess the healthcare resource utilisation of patient and caregiver through modified Resource Utilisation in Dementia Lite (RUD-Lite) Instrument.
Measured: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
Total healthcare expenditure during the last year of life through analysis of medical bills
We will calculate total healthcare expenditure during the last year of patient's life as the sum total of expenditures incurred at in-patient clinics, out-patient clinics, and visits to emergency department and on prescription drugs.
Measured: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)

Secondary outcomes (3)

Caregiver's perception of patient's quality of life at end-of-life, assessed after patient's death
We will assess caregiver's perception of patient's end-of-life care after patient's death through the Satisfaction With Care at the End of Life in Dementia (SWC-EOLD) scale. The scale has 10 items, each measured on a 4-point likert scale ranging from 1 to 4 as follows: "strongly disagree", "disagree", "agree", "strongly agree". The total SWC-EOLD score is computed by the summation of all 10 items (range of 10 to 40), with higher scores indicating more satisfaction.
Measured: 6 weeks bereavement
Caregiver's bereavement adjustment
Post-patient death bereavement adjustment will be assessed through the Brief Grief Questionnaire. This is a 5-item interview instrument for screening complicated grief. For each item, the scale ranges from 0 to 2 as follows: "not at all", "somewhat" and "a lot". The total score is computed by summing up the score for each item. If the total score is 5 or more, it may be suggestive of the presence of the syndrome of complicated grief.
Measured: 6 months bereavement
Cultural stigma associated with dementia
We will assess the cultural stigma associated with dementia by asking in-depth questions such as caregiver's perception of dementia before and after patient's diagnosis, caregiver's experience of outsiders' responses and attitudes towards dementia and how physicians give the diagnosis of dementia.
Measured: Up to 6 months post-bereavement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 May 2018Dec 2026

First posted22 Dec 2017
Study start8 May 2018
Primary completion30 Oct 2024
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Advanced DementiaStudies of the same condition, open and under way.
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: Cohort
Time perspective: Prospective
Enrolment: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03382223
Sponsor's protocol ID: 2017/2989
Acronym: PISCES
Status last verified: Apr 2026
First submitted: 7 Dec 2017
Last updated: 17 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Malhotra C, Chaudhry I, Shah SU, Ostbye T, Malhotra R. Trajectories of negative and positive experiences of caregiving for older adults with severe dementia: application of group-based multi-trajectory modelling. BMC Geriatr. 2024 Feb 19;24(1):172. doi: 10.1186/s12877-024-04777-w.
PubMed 38373922
Malhotra C, Vishwanath P, Yong JR, Ostbye T, Seow D, Yap P, Tan LL, Tham WY, Vaingankar J, Foo J, Tan BY, Tong K, Ng WC, Allen JC Jr, Malhotra R, Tan WM, Wee SL, Ng LL, Goveas R, Mok V, Sim A, Ng WF, Wong HK, Balasundaram B, Tan RQ, Ong PS, Cheong CY, Yee Chung Pheng A, Tiong C, Hum A, Lee A, Finkelstein EA. A Prospective Longitudinal Study of Caregivers of Community Dwelling Persons with Severe Dementia (PISCES): Study Protocol. J Alzheimers Dis. 2020;75(2):403-416. doi: 10.3233/JAD-190897.
PubMed 32280086

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Advanced Dementia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Panel Study Investigating Status of Cognitively Impaired Elderly in Singapore
ClinicalTrials.gov ID: NCT03382223
Acronym / sponsor ID: PISCES / 2017/2989
Conditions: Advanced Dementia
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 400 participants (estimated)
Lead sponsor: Duke-NUS Graduate Medical SchoolUniversity, hospital or other
Study start: 8 May 2018 (actual)
Primary completion: 30 Oct 2024 (actual)
Study completion: Dec 2026 (estimated)
First posted: 22 Dec 2017 (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.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: This is a prospective study of primary informal caregivers of 400 patients dying with severe dementia (PDSD) who will be surveyed every 4 months for a period of 2 years or until the patient passes away and then post-death 6 weeks and 6 months to assess bereavement of the caregiver. Treating physicians of the patients will also be invited to take part in the study.

Key inclusion criteria (8 listed)

Age ≥ 21 years old
Singaporean/Singapore Permanent Resident
Intact cognition determined through the Abbreviated Mental Test (AMT) for those who are ≥ 65 years old
Patients who score 20 or more on QDRS answered by caregivers will be considered to have severe dementia
Main person or one of the main persons providing care to patient (e.g. accompanying patient for doctor's visits, helping patient with day to day activities)

Key exclusion criteria (2 listed)

Caregivers ≥ 65 years old with cognitive impairment or serious mental illness determined through AMT
Foreign domestic workers/maids

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change in quality of life of patient
Time frame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
We will assess the quality of life of patient by asking caregivers the list of comorbidities and acute medical conditions that patient has, patient's experience of symptoms, patient's functional status and behaviours that patient exhibits.
Change in quality of care received by patient
Time frame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
We will assess the quality of care received by patient by asking the caregiver of any use of tube-feeding, physical restraint and other medical interventions; as well as checking with the caregiver if they are satisfied with the care provided for patient.
Change in caregiver's resilience
Time frame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
We will assess caregiver's resilience through the abbreviated version of the Connor-Davidson Resilience Scale (CD-RISC), the CD-RISC 2. Only 2 items will be adapted from CD-RISC. For each item, it is rated on a 5-point scale, ranging from 0 to 4 as follows: "not true at all", "rarely true", "sometimes true", "often true" and "true nearly all of the time", with higher scores reflecting greater resilience.
Change in caregiver burden
Time frame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
We will assess caregiver burden through modified Caregiver Reaction Assessment (CRA) Instrument. This instrument captures 5 domains of caregiver reaction and we adopted 4 out of the 5 domains. Each item is scored on a five-point likert scale, ranging from 0 to 4 as follows: "strongly disagree", "disagree", "neither agree nor disagree", "agree" and "strongly agree". We amended and included "not applicable" to the scale as well. The items constituting a particular domain are averaged to generate subscale scores. A higher score on the subscales indicate greater negative effects of caregiving in those domains.
Change in caregiver's ability to cope
Time frame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
We will assess caregiver's ability to cope through the BriefCOPE instrument. This instrument measures 14 conceptually differentiable coping reactions; each of which comprises of 2 subscales. The scale ranges from 0 to 3 as follows: "I haven't been doing this at all", "I've been doing this a little bit", "I've been doing this a medium amount" and "I've been doing this a lot". This measure does not compute the overall score. The scales are analysed separately to see what its relation is to other variables.
Change in caregiver's levels of emotional distress
Time frame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
We will assess caregiver's anxiety and depression through the Hospital Anxiety and Depression Scale (HADS). The instrument comprises seven questions for anxiety and seven questions for depression. Each item comprises of a four point (0-3) response category. Hence the possible score ranges from 0 to 21 for anxiety and for depression. A score of 0 to 7 for either subscale is regarded as being in the normal range, a score of 11 or higher indicates probable presence of mood disorder and a score of 8 to 10 is suggestive of the presence of the respective state.
Change in caregiver's awareness of prognostic information
Time frame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
We will assess preferences of caregivers for the disclosure of prognostic information of patient.
Change in caregiver's grief experience
Time frame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
We will assess caregiver's grief experience through the MM Caregiver Grief Inventory- Short Form (MM-CGI-SF). The instrument consists of 3 domains (each domain has 6 items) with a total of 18 items. For each item, the scale ranges from 1 to 5 as follows: "strongly disagree", "disagree", "somewhat agree", "agree" and "strongly agree". The subscale is computed by summing up the scores of the 6 items for each domain. Higher scores may indicate a need for formal intervention or support assistance to enhance coping, while lower scores may indicate denial or a downplaying of distress or positive adaptation if the individual is not showing other signs of suppressed grief. The total grief level is computed by summing up the scores for the 18 items.The higher the score, the greater the level of grief experienced by the caregiver, vice versa.
Change in resource utilisation for patient
Time frame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
We will assess the healthcare resource utilisation of patient and caregiver through modified Resource Utilisation in Dementia Lite (RUD-Lite) Instrument.
Total healthcare expenditure during the last year of life through analysis of medical bills
Time frame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
We will calculate total healthcare expenditure during the last year of patient's life as the sum total of expenditures incurred at in-patient clinics, out-patient clinics, and visits to emergency department and on prescription drugs.

3 secondary outcomes

Caregiver's perception of patient's quality of life at end-of-life, assessed after patient's death
Time frame: 6 weeks bereavement
Caregiver's bereavement adjustment
Time frame: 6 months bereavement
Cultural stigma associated with dementia
Time frame: Up to 6 months post-bereavement

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
Derived from this study: PubMed 38373922Malhotra C, Chaudhry I, Shah SU, Ostbye T, Malhotra R. Trajectories of negative and positive experiences of caregiving for older adults with severe dementia: application of group-based multi-trajectory modelling. BMC Geriatr. 2024 Feb 19;24(1):172. doi: 10.1186/s12877-024-04777-w.
Derived from this study: PubMed 32280086Malhotra C, Vishwanath P, Yong JR, Ostbye T, Seow D, Yap P, Tan LL, Tham WY, Vaingankar J, Foo J, Tan BY, Tong K, Ng WC, Allen JC Jr, Malhotra R, Tan WM, Wee SL, Ng LL, Goveas R, Mok V, Sim A, Ng WF, Wong HK, Balasundaram B, Tan RQ, Ong PS, Cheong CY, Yee Chung Pheng A, Tiong C, Hum A, Lee A, Finkelstein EA. A Prospective Longitudinal Study of Caregivers of Community Dwelling Persons with Severe Dementia (PISCES): Study Protocol. J Alzheimers Dis. 2020;75(2):403-416. doi: 10.3233/JAD-190897.

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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.

Chetna Malhotra, MD, MPH principal investigator

Lien Centre for Palliative Care/Duke-NUS Medical School

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Dementia, run by Duke-NUS Graduate Medical School at 9 sites in Singapore.

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 8 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Singapore. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in quality of life of patient (time frame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03382223, which also lists 2 linked publications.

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 17 Apr 2026.