Indonesia Frailty, Aging, and Longitudinal Study (INA-FRAGILE)

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Frailty

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia
    • Recruiting
    • Comprehensive Geriatric Clinic, Cipto Mangunkusumo Hospital
    • Contact: Rahmi Istanti, SKM, MARS; Email: salontanti@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and at 1 year
Change from baseline in fall incidence at 1 year	Fall incidence: number of fall during observational period.	Baseline and at 1 year
Change from baseline in hospitality at 1 year	Hospitality: number of hospital admission (emergency or inpatient care) during observational period.	Baseline and at 1 year
Change from baseline in mortality at 1 year	Mortality: number of subjects died after 1 year observation.	Baseline and at 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in handgrip strength at 1 year	Measurement: using Jamar Hydraulic Hand Dynamometer Model J00105	Baseline and at 1 year
Change from baseline in gait speed at 1 year	Measurement: 15-feet walking test	Baseline and at 1 year
Change from baseline in functional status at 1 year	Measurement: Barthel Index Activities of Daily Living (B-ADL) & Lawton Instrumental & Activities of Daily Living (L-IADL) questionnaires.	Baseline and at 1 year
Change from baseline in cognitive status at 1 year	Measurement: Abbreviated mental test (AMT) questionnaire.	Baseline and at 1 year
Change from baseline in mental status at 1 year	Measurement: Short Form Geriatric Depression Scale (GDS) questionnaire.	Baseline and at 1 year
Change from baseline in nutritional status at 1 year	Measurement: Mini Nutritional Assessment (MNA) questionnaire.	Baseline and at 1 year
Change from baseline in sarcopenia status at 1 year	Categories: no sarcopenia, pre-sarcopenia, sarcopenia, and severe sarcopenia.	Baseline and at 1 year
Change from baseline in comorbidities status at 1 year	Measurement: Cumulative Illness Rating Scale (CIRS)	Baseline and at 1 year

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Siti Setiati, Prof, MD, Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta; Study Chair: Purwita Laksmi, MD, Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta; Study Chair: Rahmi Istanti, SKM, MARS, Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta; Study Chair: Tirza Tamin, MD, PhD, Department of Rehabilitation & Physical Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: January 19, 2015
• First Submitted That Met QC Criteria: January 19, 2015
• First Posted (Estimate): January 26, 2015

Study Record Updates

• Last Update Posted (Estimate): August 26, 2015
• Last Update Submitted That Met QC Criteria: August 24, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Elderly; Polypharmacy; Pre-frailty; Mortality; Functional status; Comorbidity; Health-related quality of life; Frailty; Nutrition status; Fit; Robust; Sociodemography status; Cognitive status; Depression status; Fall incidence; Hospitality
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: INA-FRAGILE01