Indonesia Frailty, Aging, and Longitudinal Study (INA-FRAGILE)
Tahapan Penelitian : Recruit
Sponsor:
Indonesia University
Mitra Pelaksana:
Indonesia University
No Registry
INA-DCD9X4Y
Tanggal Input Registry : 19-01-2015
Tracking Information | |
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Tanggal Antisipasi Studi | 01-06-2015 |
Outcome Primer | Change from baseline in frailty status at 1 year. Frailty status is divided into Fit (robust), Pre-frail, and Frailty. |
Outcome Skunder | 1. Change from baseline in health-related quality of life at 1 year Health-related quality of life: using Euro Quality of Life-5 Dimension (EQ-5D) questionnaire. 2. Change from baseline in fall incidence at 1 year Fall incidence: number of fall during observational period. 3. Change from baseline in hospitality at 1 year Hospitality: number of hospital admission (emergency or inpatient care) during observational period. 4. Change from baseline in mortality at 1 year Mortality: number of subjects died after 1 year observation. |
Descriptive Information | |
Judul Penelitian Popular | Indonesia Frailty, Aging, and Longitudinal Study (INA-FRAGILE) |
Judul Penelitian Ilmiah | Indonesia Frailty, Aging, and Longitudinal Study (INA-FRAGILE) |
Jenis Penelitian | Observasional |
Intervensi | Observational: Cohort Prospective |
Jumlah Subyek Penelitian | 300 |
Recruitment Information | |
Eligibility Criteria | Inclusion Criteria: 1. Elderly aged >= 60 years old 2. Fit (robust) or pre-frailty; 3. Capable to understand and carry-out the instruction.Exclusion Criteria: 1. Unwilling to join the study; 2. Abbreviated Mental Test (AMT) score < 8; 3. Geriatric Depression Scale (GDS) score >= 10; 4. Body mass index (BMI) 3 times upper normal limit; 7. Acute illness during inclusion period, eg. pneumonia, pain due to acute arthritis (visual analog scale >6/10), stroke attack, crisis hypertension; 8. Severe cardiac dysfunction: acute decompensated heart failure and/or chronic heart failure functional class III or IV (New York Heart Association classification); 9. Severe pulmonary dysfunction: acute exacerbation of chronic obstructive lung disease stage III or IV (GOLD classification), and/or PaO2 levels < 60 mmHg. |
Administrative Information | |
Nomor Persetujuan Etik | - |
Nomor Persetujuan Material Transfer Agreement | - |
Nomor Persetujuan Pelaksanaan Uji Klinik | - |
Other Study ID Numbers | NCT02345083 |
Contact Person | Siti Setiati |