Frailty Status and Quality of Life in Elderly

A Cohort Study of Frailty Status Transition and Its Impact to Quality of Life in Outpatient Elderly

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 of frailty transitional status and its correlation with quality of life in Indonesian elderly outpatients.

Study Overview

• Status: Completed
• 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 off ers 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 of frailty transitional status and its correlation with quality of life in Indonesian elderly.

• Study Type: Observational
• Enrollment (Actual): 269

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 2013-April 2014.

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?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in frailty status at 24 months	Frailty status is divided into Fit (robust), Pre-frail, and Frailty.	Baseline and at 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in mortality at 24 months	Mortality: number of subjects died after 24 months observation.	at 24 months
Change from baseline in morbidities at 24 months	Morbidities: number of diseases in subjects (using Charlson Comorbidity Index)	Baseline and at 24 months

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

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: March 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 2, 2015
• First Submitted That Met QC Criteria: January 6, 2015
• First Posted (Estimate): January 7, 2015

Study Record Updates

• Last Update Posted (Estimate): January 7, 2015
• Last Update Submitted That Met QC Criteria: January 6, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Elderly; Pre-frailty; Mortality; Functional status; Comorbidity; Frailty; Nutrition status; Fit; Robust; Sociodemography status; Cognitive status; Depression status
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: INA-FRAGILE00