Frailty Status and Quality of Life in Elderly

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02333552
• Other study ID #: INA-FRAGILE00
• Status: Completed
• Phase: N/A
• First received: January 2, 2015
• Last updated: January 6, 2015
• Start date: March 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Departement Kesehatan (Department of Health)
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: December 2014
• Est. primary completion date: April 2014
• 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
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

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
Primary	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	No
Secondary	Change from baseline in mortality at 24 months	Mortality: number of subjects died after 24 months observation.	at 24 months	No
Secondary	Change from baseline in morbidities at 24 months	Morbidities: number of diseases in subjects (using Charlson Comorbidity Index)	Baseline and at 24 months	No