Frailty Status and Quality of Life in Elderly

Overview

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.

Full Title of Study: “A Cohort Study of Frailty Status Transition and Its Impact to Quality of Life in Outpatient Elderly”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2014

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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Indonesia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Siti Setiati, Prof. Siti Setiati, MD, PhD, SpPD-KGer, MEpid – Indonesia University
  • Overall Official(s)
    • Siti Setiati, Prof, MD, Principal Investigator, Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta
    • Purwita Laksmi, MD, Study Chair, Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta
    • Rahmi Istanti, SKM, MARS, Study Chair, Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.