Frailty Status and Quality of Life in Elderly

NCT02333552 | Completed

• 1 other identifier: INA-FRAGILE00
• Study Type: observational
• Target: 269
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Frailty; Quality of Life

Keywords

Frailty; Pre-frailty; Fit; Robust; Elderly; Sociodemography status; Functional status; Cognitive status; Nutrition status; Comorbidity; Mortality; Depression status

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline in mortality at 24 months

  at 24 months

• Change from baseline in morbidities at 24 months

  Baseline and at 24 months

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Elderly aged \>= 60 years old
• Fit (robust) or pre-frailty;
• Capable to understand and carry-out the instruction.

You may not qualify if:

• Unwilling to join the study;
• Abbreviated Mental Test (AMT) score \< 8;
• Geriatric Depression Scale (GDS) score \>= 10;
• Body mass index (BMI) \<18,5 Kg/m2;
• Malnutrition (according to Mini Nutritional Assessment/MNA);
• Liver cirrhosis, severe liver dysfunction, or serum ALT levels \>3 times upper normal limit;
• Severe cardiac dysfunction: acute decompensated heart failure and/or chronic heart failure functional class III or IV (New York Heart Association classification);
• Severe pulmonary dysfunction: acute exacerbation of chronic obstructive lung disease stage III or IV (GOLD classification), and/or PaO2 levels \< 60 mmHg.

Sponsors & Collaborators

• Indonesia University: lead

Related Publications (2)

• 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.

  PMID: 24534517 BACKGROUND

• 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.

  PMID: 25348178 BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Siti Setiati, Prof, MD

  Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Siti Setiati, MD, PhD, SpPD-KGer, MEpid

Study Record Dates

• First Submitted: January 2, 2015
• First Posted: January 7, 2015
• Study Start: March 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 7, 2015

Record last verified: 2015-01