Clinical trial NCT03382223: Panel Study Investigating Status of Cognitively Impaired Elderly in Singapore
Official title: Panel Study Investigating Status of Cognitively Impaired Elderly in Singapore
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Dementia
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 400
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria for primary informal caregivers are:

1. Age ≥ 21 years old
2. Singaporean/Singapore Permanent Resident
3. Intact cognition determined through the Abbreviated Mental Test (AMT) for those who are ≥ 65 years old
4. Patients who score 20 or more on QDRS answered by caregivers will be considered to have severe dementia
5. 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)
6. 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)
7. Main person or one of the main persons involved in making decisions regarding treatment patient receives

Exclusion Criteria for primary informal caregivers are:

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

Inclusion Criteria for physicians are:

(a) Caregivers of patients they are treating are enrolled in the study

Primary outcomes:
measure: Change in quality of life of patient
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
measure: Change in quality of care received by patient
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
measure: Change in caregiver's resilience
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
measure: Change in caregiver burden
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
measure: Change in caregiver's ability to cope
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
measure: Change in caregiver's levels of emotional distress
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
measure: Change in caregiver's awareness of prognostic information
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
measure: Change in caregiver's grief experience
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
measure: Change in resource utilisation for patient
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
measure: Total healthcare expenditure during the last year of life through analysis of medical bills
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 month, 12 month, 16 month, 20 month, 24 month)
Secondary outcomes:
measure: Caregiver's perception of patient's quality of life at end-of-life, assessed after patient's death
timeFrame: 6 weeks bereavement
measure: Caregiver's bereavement adjustment
timeFrame: 6 months bereavement
measure: Cultural stigma associated with dementia
timeFrame: Up to 6 months post-bereavement
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tsao Foundation
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Alzheimer's Disease Association
city: Singapore
country: Singapore
facility: Care for the Elderly Foundation
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Singapore
country: Singapore
facility: Institute of Mental Health
city: Singapore
country: Singapore
facility: Jurong Community Hospital
city: Singapore
country: Singapore
facility: St. Luke's Hospital
city: Singapore
country: Singapore
facility: Khoo Teck Puat Hospital
Study officials:
affiliation: Lien Centre for Palliative Care/Duke-NUS Medical School
name: Chetna Malhotra, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.