Depression Clinical Trial
— SLASOfficial title:
Gerontology Research Programme: Biological, Clinical, Psychosocial and Behavioural Predictors of Health Status in Prospectively Followed-up Cohorts of Elderly Persons
Verified date | March 2019 |
Source | National University, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The Gerontology Research Programme (GRP) in the National University Singapore's Department of Psychological Medicine, was formed to coordinate and facilitate the conduct of multi-disciplinary research on in a wide range of research on ageing and health. The establishment of the Singapore Longitudinal Aging Cohort will provide a large community-based cohort of elderly subjects for observational studies with useful clinical applications. Research synergy is achieved in terms of pooling multi-disciplinary expertise, and combining genetic, biological, environmental, behavioural, social, clinical, and health services approaches to gerontological research.
Status | Active, not recruiting |
Enrollment | 6183 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years and older |
Eligibility |
Inclusion Criteria: - Ability to self-ambulate - Adequate cognitive capacity for participation Exclusion Criteria: - Individuals with severe physical or mental disabilities were excluded. |
Country | Name | City | State |
---|---|---|---|
Singapore | National University of Singapore | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University, Singapore | Duke-NUS Graduate Medical School, Karolinska Institutet, Khoo Teck Puat Hospital, Melbourne Health, National University Hospital, Singapore, Ng Teng Fong General Hospital, Shanghai Jiao Tong University School of Medicine, Singapore Institute of Technology, St Luke's Hospital, Singapore, St. Paul's Hospital, Canada, Tan Tock Seng Hospital, Université de Sherbrooke, University Hospital Tuebingen, University Hospital, Basel, Switzerland, University of British Columbia, University of California |
Singapore,
American Psychiatric Association. Diagnostic and statistical manual of Mental Disorders, (4th ed., text rev.; DSM-IV-TR). American Psychiatric Association, Washington. 2000.
Benedict RHB. Brief visuospatial memory test - revised: Professional manual. Lutz, FL: Psychological Assessment Resources, Inc; 1997.
D'Elia LF, Satz P, Uchiyama CL, White T. Color Trails Test: Professional Manual. Odessa (Florida): Psychological Assessment Resources; 1996.
Folstein MF, Folstein SE, McHugh PR, Fanjiang G. Mini-Mental State Examination: MMSE user's guide. Psychology Assessment Resources; 2000.
Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. — View Citation
Jorm AF. A short form of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE): development and cross-validation. Psychol Med. 1994 Feb;24(1):145-53. Erratum in: Psychol Med 1995 Mar;25(2):437. — View Citation
Kaplan E, Goodglass H, Weintraub S. Boston naming test. Pro-ed; 2001.
Kluger A, Gianutsos JG, Golomb J, Wagner A Jr, Wagner D, Scheurich S. Clinical features of MCI: motor changes. Int Psychogeriatr. 2008 Feb;20(1):32-9. — View Citation
Koivumaa-Honkanen H, Honkanen R, Viinamäki H, Heikkilä K, Kaprio J, Koskenvuo M. Self-reported life satisfaction and 20-year mortality in healthy Finnish adults. Am J Epidemiol. 2000 Nov 15;152(10):983-91. — View Citation
Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. — View Citation
MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. — View Citation
Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. — View Citation
Ng TP, Broekman BF, Niti M, Gwee X, Kua EH. Determinants of successful aging using a multidimensional definition among Chinese elderly in Singapore. Am J Geriatr Psychiatry. 2009 May;17(5):407-16. doi: 10.1097/JGP.0b013e31819a808e. — View Citation
Niti M, Yap KB, Kua EH, Tan CH, Ng TP. Physical, social and productive leisure activities, cognitive decline and interaction with APOE-epsilon 4 genotype in Chinese older adults. Int Psychogeriatr. 2008 Apr;20(2):237-51. doi: 10.1017/S1041610207006655. Epub 2008 Jan 11. — View Citation
O'Bryant SE, Waring SC, Cullum CM, Hall J, Lacritz L, Massman PJ, Lupo PJ, Reisch JS, Doody R; Texas Alzheimer's Research Consortium. Staging dementia using Clinical Dementia Rating Scale Sum of Boxes scores: a Texas Alzheimer's research consortium study. Arch Neurol. 2008 Aug;65(8):1091-5. doi: 10.1001/archneur.65.8.1091. — View Citation
Portet F, Ousset PJ, Visser PJ, Frisoni GB, Nobili F, Scheltens P, Vellas B, Touchon J; MCI Working Group of the European Consortium on Alzheimer's Disease (EADC). Mild cognitive impairment (MCI) in medical practice: a critical review of the concept and new diagnostic procedure. Report of the MCI Working Group of the European Consortium on Alzheimer's Disease. J Neurol Neurosurg Psychiatry. 2006 Jun;77(6):714-8. Epub 2006 Mar 20. Review. — View Citation
Rabin R, Oemar M, Oppe M, Janssen B, Herdman M. EQ-5D-3L User Guide: Basic information on how to use the EQ-5D-3L instrument. Rotterdam: EuroQol Group; 2011.
Randolph C, Tierney MC, Mohr E, Chase TN. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 1998 Jun;20(3):310-9. — View Citation
Rey A. L'examen psychologique dans les cas d'encéphalopathie traumatique.(Les problems.). Archives de psychologie (1941).
Siebeling L, Wiebers S, Beem L, Puhan MA, Ter Riet G. Validity and reproducibility of a physical activity questionnaire for older adults: questionnaire versus accelerometer for assessing physical activity in older adults. Clin Epidemiol. 2012;4:171-80. doi: 10.2147/CLEP.S30848. Epub 2012 Jul 16. — View Citation
Tinetti ME, Williams TF, Mayewski R. Fall risk index for elderly patients based on number of chronic disabilities. Am J Med. 1986 Mar;80(3):429-34. — View Citation
Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986 Feb;34(2):119-26. — View Citation
Vinkers DJ, Gussekloo J, Stek ML, Westendorp RG, Van Der Mast RC. The 15-item Geriatric Depression Scale (GDS-15) detects changes in depressive symptoms after a major negative life event. The Leiden 85-plus Study. Int J Geriatr Psychiatry. 2004 Jan;19(1):80-4. — View Citation
Ware JE, Keller SD, Kosinski M. SF-12: How to Score the SF-12 Physical and Mental Health Summary Scales. Lincoln, RI: QualityMetric; 1998.
Ware JE, Kolinski M, Keller SD. How to Score the SF-12 Physical and Mental Health Summaries: A User's Manual. Boston: The Health Institute, New England Medical Centre, Boston, MA; 1995.
Wechsler D. Wechsler adult intelligence scale-fourth. San Antonio, TX: The Psychological Corporation Google Scholar; 2008.
Yeo D, Gabriel C, Chen C, Lee S, Loenneker T, Wong M. Pilot validation of a customized neuropsychological battery in elderly Singaporeans. Neurol J South East Asia 1997 2(123).
* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dementia and Mild Cognitive Impairment (MCI) Subtyping (Clinical diagnosis of different stages of Dementia) | Dementia and MCI is determined by clinical case conference adjudication where geriatric and psychiatric clinicians convene to determine the diagnosis of a case, utilizing the data from (i) Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) (4-5); (ii) Clinical Dementia rating scale: a 5-point scale used to characterize 6 cognitive and functional domain performance: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care (6). Information to make each rating is obtained through a semi-structured interview of the patient and a reliable informant (e.g. family member). A higher score indicates increased severity of cognitive impairment; (iii) Informant Questionnaire of Cognitive Decline in the Elderly (IQCODE) - reliable informants report on the cognitive state of the participant (7); (iv) a scale on self-reported subjective cognitive difficulties; and (v) a neuropsychological assessment battery (described below). | 20 years - once every 3-4 years | |
Primary | Global and specific domain cognitive functioning ability (Measuring of Global and Specific domain of Cognitive functions) | MMSE (4) and MoCA (5) - 30 items, total scores range from 0-30, higher scores indicate better cognitive functioning. A cut-off of a score of =<25 is determined as screening positive for cognitive impairment. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (8) - measures immediate memory, visuospatial ability, language, attention, delayed memory, and a global cognitive functioning score (a summation of domain scores). A neurocognitive battery measures immediate and delayed memory/learning, visuospatial ability, language, attention, and executive functioning. All domains are calculated by weighted averages of age and education adjusted scores. Tests: (i) Digit Span forward and backwards tasks (9); (ii) Rey's Auditory Verbal Learning Test (10); (iii) Story Memory Test (11); (iv) Brief Visuospatial Memory Test - Revised (12); (v) Boston Naming Test (13); (vi) Clock Reading Test; (viii) Colour Trials 1 and 2 (14); (ix) Block Design task (9). |
20 years - once every 3-4 years | |
Primary | Frailty (Measuring the physical and Cognitive Frailty) | Physical frailty was assessed by scores (1 = present, 0 = absent) for five components (shrinking, weakness, slowness, exhaustion, and low Physical Activity (PA)) proposed by Fried et al (3), with the following operational modifications: (i) Shrinking was defined by unintentional weight loss of 4 kg or more in the past 6 months, or BMI less than 18.5 kg/m2, or calf circumference of 31 cm or less. (ii) Weakness was assessed by knee extension strength task in kilogram. (iii) Slowness was assessed by a gait speed test (15). (iv) Exhaustion was measured as a summed score of 3 questions (1-5), "Did you have lots of energy/feel tired (reverse-scored, rs)/worn out (rs)?" (16). A score of <10 was used to denote exhaustion. (v) Low PA was measured by the LASA PA scale, with those falling below the local gender-specific lowest quintile deemed as low PA (17). Participants are categorised by their total scores as robust (score = 0), pre-frail (score = 1-2), and frail (score = 3-5). | 20 years - once every 3-4 years | |
Primary | Depressive symptoms and diagnosis (Measuring of Depressive symptoms and assessment of stages of Depression) | Depressive symptoms are assessed by the 15-item version of the Geriatric Depression Scale (GDS), with a higher score indicating higher depressivity (18). A cut-off score of 5 is used as indicating the presence of depression. Additionally, participants are formally diagnosed by a medically trained research fellow for common mood-related psychiatric conditions using the Structured Clinical Interview for DSM Disorders (SCID) of DSM IV-TR (1), such as Major Depressive Disorder, Minor Depression, Dysthmic Disorder, Mania/Hypomania disorder, Anxiety and panic disorder, Obsessive-compulsive disorder, Post traumatic stress disorder, Psychotic disorder, Mood disorder due to a General Medical Condition and Alcohol abuse disorders, if they screen as positive for depression on the GDS. | 20 years - once every 3-4 years | |
Primary | Successful ageing (Measuring the biological, psycho-social and lifestyle factors associated with Successful Ageing) | Successful aging is previously defined (25). Briefly, a score of successful ageing reflects the overall and physical health, cognitive, emotional, social well-functioning, including life engagement & satisfaction. Physical health and functional well-being was defined as a "good/excellent" self-reported health and IADL independence (20). Cognitive well-functioning and emotional wellbeing was denoted by a minimum MMSE score of 26 (4), and a score below 5 on the GDS (=5) (18). Social functioning and active engagement in life activities was assessed using a validated questionnaire (26) on participation levels in social, recreational, civic activities, voluntary work, employment/business, and domestic activities. Overall positive life satisfaction was determined using the Life Satisfaction Scale that assessed interest in life, happiness, loneliness, and general ease of living (27). Total summed score ranges from 4 to 18, with the lowest decile indicating a positive life satisfaction. | 20 years - once every 3-4 years | |
Secondary | Self-reported independent functioning (Measuring the BADL and IADL) | Self-reported Independent Functioning is assessed using the Barthel Index (19) and the Lawton and Brody Instrumental Activity of Daily Living Inventory (20), whereby participants report the degree of dependence on others for several daily and instrumental tasks. | 20 years - once every 3-4 years | |
Secondary | Physical performance (Measuring the physical performance tests) | Assessed by the Physical Performance Battery which includes the Performance-Oriented Mobility Assessment-Balance and Gait scales (21-22), with a higher score indicating a higher performance in terms of balance or gait; as well as the amount of force displaced in Newtons on a handgrip and knee extension dynamometer. The scores for each of the tests would be combined into a weighted average that reflects overall physical performance. | 20 years - once every 3-4 years | |
Secondary | Health services utilization (Measuring cost and frequency of health services utilization) | Self-reported frequency of doctor visits over a past 12-month period. | 20 years - once every 3-4 years | |
Secondary | Quality of life (Measuring the Quality of life SF 12) | Assessed by self-reported scales: (i) EQ5D- 3L - a measure of health-related quality of life that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale (23). (ii) 12-Item Short Form Survey (SF-12) is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective, covering the eight domains of health outcomes: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional & mental health (24). | 20 years - once every 3-4 years | |
Secondary | Mortality (Measuring the risk factors related to mortality) | Date and cause of death data is collected by computerized record linkage with the National Death Registry through the Singapore National Registry of Diseases Office (NRDO). | 20 years | |
Secondary | Post-bronchodilation spirometry (Measuring the lung functions tests) | A measurement of lung function which yields the (i) Forced vital capacity - the determination of the vital capacity from a maximally forced expiratory effort; (ii) the FEV1 - volume that has been exhaled at the end of the first second of forced expiration; and the (iii) Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter. Measurements are made following American Thoracic Society (ATS) criteria for spirometric standardization and procedures, based on the best of four readings, with less than 5% variation in the two best readings. FEV1 is expressed as the percentage of predicted from local norms. | 20 years - once every 3-4 years |
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