Indonesia Frailty, Aging, and Longitudinal Study

Quality of Life Clinical Trial

— INA-FRAGILE  

Official title:

Indonesia Frailty, Aging, and Longitudinal Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02345083
• Other study ID #: INA-FRAGILE01
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2015
• Last updated: August 24, 2015
• Start date: June 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2015
• Source: Indonesia University
• Contact: Siti Setiati, Prof, MD
• Email: s_setiati[@]yahoo.com
• Is FDA regulated: No
• Health authority: Indonesia: Departement Kesehatan (Department of Health)
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Frailty
• Quality of Life

Locations

Country	Name	City	State
Indonesia	Comprehensive Geriatric Clinic, Cipto Mangunkusumo Hospital	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

Laksmi PW. Frailty syndrome: an emerging geriatric syndrome calling for its potential intervention. Acta Med Indones. 2014 Jul;46(3):173-4. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in handgrip strength at 1 year	Measurement: using Jamar Hydraulic Hand Dynamometer Model J00105	Baseline and at 1 year	No
Other	Change from baseline in gait speed at 1 year	Measurement: 15-feet walking test	Baseline and at 1 year	No
Other	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	No
Other	Change from baseline in cognitive status at 1 year	Measurement: Abbreviated mental test (AMT) questionnaire.	Baseline and at 1 year	No
Other	Change from baseline in mental status at 1 year	Measurement: Short Form Geriatric Depression Scale (GDS) questionnaire.	Baseline and at 1 year	No
Other	Change from baseline in nutritional status at 1 year	Measurement: Mini Nutritional Assessment (MNA) questionnaire.	Baseline and at 1 year	No
Other	Change from baseline in sarcopenia status at 1 year	Categories: no sarcopenia, pre-sarcopenia, sarcopenia, and severe sarcopenia.	Baseline and at 1 year	No
Other	Change from baseline in comorbidities status at 1 year	Measurement: Cumulative Illness Rating Scale (CIRS)	Baseline and at 1 year	No
Primary	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	No
Secondary	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	No
Secondary	Change from baseline in fall incidence at 1 year	Fall incidence: number of fall during observational period.	Baseline and at 1 year	No
Secondary	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	No
Secondary	Change from baseline in mortality at 1 year	Mortality: number of subjects died after 1 year observation.	Baseline and at 1 year	No