Clinical trial NCT02345083: Indonesia Frailty, Aging, and Longitudinal Study
Official title: Indonesia Frailty, Aging, and Longitudinal Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Frailty
Quality of Life
Keywords: Frailty
Pre-frailty
Fit
Robust
Elderly
Sociodemography status
Functional status
Cognitive status
Nutrition status
Comorbidity
Polypharmacy
Mortality
Depression status
Health-related quality of life
Fall incidence
Hospitality
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fit or pre-frail elderly aged \>= 60 years old who came to Comprehensive Geriatric Clinics, Cipto Mangunkusumo General Hospital, Jakarta, during March 2015-March 2016.

Brief summary: Frailty is a dynamic process from fit (robust) and pre-frail elderly. There is no previous study that determine the risk factors from fit to pre-frailty and pre-frailty to frailty in Indonesian elderly.

This study was aimed to define the risk factors and clinical outcomes of frailty transitional status in Indonesian elderly.

Detailed description: Frailty is an age-associated, biological syndrome characterized by decreased biological reserves, due to dysregulation of several physiological systems, which puts an individual at risk when facing minor stressors, and is associated with poor outcomes (ie, disability, death, and hospitalization).

Frailty identifies a high-risk subgroup and offers characteristics of great clinical importance: a higher reversibility at early stages than disability, and a higher predictive value than chronic disease for adverse outcomes at older ages. It is also the most common condition leading to death in community-dwelling older people.

However, there is current consensus that physical frailty is potentially reversible. It is hence useful to objectively detect frailty among frail elderly persons, as frailty indices serve a useful purpose for risk stratification, predicting need for institutional care and planning of services needed.

To date, there is no study or information about frailty status in Indonesia elderly. This study was aimed to define the risk factors and clinical outcomes of frailty transitional status in Indonesian elderly.

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) \<18,5 Kg/m2;
5. Malnutrition (according to Mini Nutritional Assessment/MNA);
6. Liver cirrhosis, severe liver dysfunction, or serum ALT levels \>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.

Primary outcomes:
measure: Change from baseline in frailty status at 1 year
timeFrame: Baseline and at 1 year
Secondary outcomes:
measure: Change from baseline in health-related quality of life at 1 year
timeFrame: Baseline and at 1 year
measure: Change from baseline in fall incidence at 1 year
timeFrame: Baseline and at 1 year
measure: Change from baseline in hospitality at 1 year
timeFrame: Baseline and at 1 year
measure: Change from baseline in mortality at 1 year
timeFrame: Baseline and at 1 year
Other outcomes:
measure: Change from baseline in handgrip strength at 1 year
timeFrame: Baseline and at 1 year
measure: Change from baseline in gait speed at 1 year
timeFrame: Baseline and at 1 year
measure: Change from baseline in functional status at 1 year
timeFrame: Baseline and at 1 year
measure: Change from baseline in cognitive status at 1 year
timeFrame: Baseline and at 1 year
measure: Change from baseline in mental status at 1 year
timeFrame: Baseline and at 1 year
measure: Change from baseline in nutritional status at 1 year
timeFrame: Baseline and at 1 year
measure: Change from baseline in sarcopenia status at 1 year
timeFrame: Baseline and at 1 year
measure: Change from baseline in comorbidities status at 1 year
timeFrame: Baseline and at 1 year
Locations:
city: Jakarta
country: Indonesia
facility: Comprehensive Geriatric Clinic, Cipto Mangunkusumo Hospital
Study officials:
affiliation: Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta
name: Siti Setiati, Prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta
name: Purwita Laksmi, MD
role: STUDY_CHAIR
affiliation: Department of Rehabilitation & Physical Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta
name: Tirza Tamin, MD, PhD
role: STUDY_CHAIR
affiliation: Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta
name: Rahmi Istanti, SKM, MARS
role: STUDY_CHAIR
References:
citation: Lee JS, Auyeung TW, Leung J, Kwok T, Woo J. Transitions in frailty states among community-living older adults and their associated factors. J Am Med Dir Assoc. 2014 Apr;15(4):281-6. doi: 10.1016/j.jamda.2013.12.002. Epub 2014 Feb 16.
citation: Laksmi PW. Frailty syndrome: an emerging geriatric syndrome calling for its potential intervention. Acta Med Indones. 2014 Jul;46(3):173-4. No abstract available.