Clinical trial NCT02333552: Frailty Status and Quality of Life in Elderly
Official title: A Cohort Study of Frailty Status Transition and Its Impact to Quality of Life in Outpatient Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Quality of Life
Keywords: Frailty
Pre-frailty
Fit
Robust
Elderly
Sociodemography status
Functional status
Cognitive status
Nutrition status
Comorbidity
Mortality
Depression status
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 269
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in frailty status at 24 months
timeFrame: Baseline and at 24 months
Secondary outcomes:
measure: Change from baseline in mortality at 24 months
timeFrame: at 24 months
measure: Change from baseline in morbidities at 24 months
timeFrame: Baseline and at 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta
name: Siti Setiati, Prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta
name: Purwita Laksmi, MD
role: STUDY_CHAIR
affiliation: Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta
name: Rahmi Istanti, SKM, MARS
role: STUDY_CHAIR
References:
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.
citation: 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.