Indonesia Frailty, Aging, and Longitudinal Study

• Conditions: Quality of Life; Frailty

• Registration Number: NCT02345083
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-19
• Study First Posted: 2015-01-26
• Study Start: 2015-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-26
• Primary Completion: 2016-03
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in frailty status at 1 year	Baseline and at 1 year	Frailty status is divided into Fit (robust), Pre-frail, and Frailty.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in mortality at 1 year	Baseline and at 1 year	Mortality: number of subjects died after 1 year observation.
Change from baseline in fall incidence at 1 year	Baseline and at 1 year	Fall incidence: number of fall during observational period.
Change from baseline in hospitality at 1 year	Baseline and at 1 year	Hospitality: number of hospital admission (emergency or inpatient care) during observational period.
Change from baseline in health-related quality of life at 1 year	Baseline and at 1 year	Health-related quality of life: using Euro Quality of Life-5 Dimension (EQ-5D) questionnaire.

Trial Locations

Locations (1)

Comprehensive Geriatric Clinic, Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta, Indonesia