NCT02345083

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 and clinical outcomes of frailty transitional status in Indonesian elderly.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

9 months

First QC Date

January 19, 2015

Last Update Submit

August 24, 2015

Conditions

FrailtyQuality of Life

Keywords

FrailtyPre-frailtyFitRobustElderlySociodemography statusFunctional statusCognitive statusNutrition statusComorbidityPolypharmacyMortalityDepression statusHealth-related quality of lifeFall incidenceHospitality

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in frailty status at 1 year

    Frailty status is divided into Fit (robust), Pre-frail, and Frailty.

    Baseline and at 1 year

Secondary Outcomes (4)

  • Change from baseline in health-related quality of life at 1 year

    Baseline and at 1 year

  • Change from baseline in fall incidence at 1 year

    Baseline and at 1 year

  • Change from baseline in hospitality at 1 year

    Baseline and at 1 year

  • Change from baseline in mortality at 1 year

    Baseline and at 1 year

Other Outcomes (8)

  • Change from baseline in handgrip strength at 1 year

    Baseline and at 1 year

  • Change from baseline in gait speed at 1 year

    Baseline and at 1 year

  • Change from baseline in functional status at 1 year

    Baseline and at 1 year

  • +5 more other outcomes

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 2015-March 2016.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Geriatric Clinic, Cipto Mangunkusumo Hospital

Jakarta, Jakarta Special Capital Region, Indonesia

RECRUITING

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: 24534517BACKGROUND

  • 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: 25348178BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological 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

  • Tirza Tamin, MD, PhD

    Department of Rehabilitation & Physical 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

Central Study Contacts

Siti Setiati, Prof, MD

CONTACT

s_setiati@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Indonesia Frailty, Aging, and Quality of Life

Study Record Dates

First Submitted

January 19, 2015

First Posted

January 26, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2016

Study Completion

August 1, 2016

Last Updated

August 26, 2015

Record last verified: 2015-08

Locations

ID(1)