FrailtyINA-FRAGILENCT02345083
Indonesia Frailty, Aging, and Longitudinal Study
An observational study of Frailty and Quality of Life, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frailty, Quality of Life
- How many people
- 300 participants
- Where
- 1 siteIndonesia
- Study dates
- Jun 2015to Aug 2016
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Elderly aged >= 60 years old
- Fit (robust) or pre-frailty;
- Capable to understand and carry-out the instruction.
Who cannot join
- 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;
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- Acute illness during inclusion period, eg. pneumonia, pain due to acute arthritis (visual analog scale >6/10), stroke attack, crisis hypertension;
- 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.
Trial locations and contacts
1 site in 1 country.
Siti Setiati, Prof, MD contact
Indonesia1 site, 1 recruiting
- Recruiting
Comprehensive Geriatric Clinic, Cipto Mangunkusumo Hospital
Jakarta, Jakarta Special Capital Region
Rahmi Istanti, SKM, MARS, salontanti@yahoo.com
About this study
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.
Read the 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 offers 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 and clinical outcomes of frailty transitional status in Indonesian elderly.
- Conditions
- Frailty, Quality of Life
- Keywords
- Frailty, Pre-frailty, Fit, Robust, Elderly, Sociodemography status, Functional status, Cognitive status, Nutrition status, Comorbidity, Polypharmacy, Mortality, Depression status, Health-related quality of life, Fall incidence, Hospitality
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in frailty status at 1 year
Frailty status is divided into Fit (robust), Pre-frail, and Frailty.
Measured: Baseline and at 1 year
Secondary outcomes (4)
Change from baseline in health-related quality of life at 1 year
Health-related quality of life: using Euro Quality of Life-5 Dimension (EQ-5D) questionnaire.
Measured: Baseline and at 1 year
Change from baseline in fall incidence at 1 year
Fall incidence: number of fall during observational period.
Measured: Baseline and at 1 year
Change from baseline in hospitality at 1 year
Hospitality: number of hospital admission (emergency or inpatient care) during observational period.
Measured: Baseline and at 1 year
Change from baseline in mortality at 1 year
Mortality: number of subjects died after 1 year observation.
Measured: Baseline and at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siti Setiati, Universitas Indonesia
- Investigators
- Siti Setiati, Prof, MD, Principal investigator, Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, JakartaPurwita Laksmi, MD, Study chair, Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, JakartaTirza Tamin, MD, PhD, Study chair, Department of Rehabilitation & Physical Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, JakartaRahmi Istanti, SKM, MARS, Study chair, Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345083
- Sponsor's protocol ID
- INA-FRAGILE01
- Acronym
- INA-FRAGILE
- Status last verified
- Aug 2015
- First submitted
- 19 Jan 2015
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24534517Laksmi PW. Frailty syndrome: an emerging geriatric syndrome calling for its potential intervention. Acta Med Indones. 2014 Jul;46(3):173-4. No abstract available.
PubMed 25348178
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indonesia Frailty, Aging, and Longitudinal Study
- ClinicalTrials.gov ID
- NCT02345083
- Acronym / sponsor ID
- INA-FRAGILE / INA-FRAGILE01
- Conditions
- Frailty, Quality of Life
- Keywords
- Frailty, Pre-frailty, Fit, Robust, Elderly, Sociodemography status, Functional status, Cognitive status
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 offers 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 and clinical outcomes of frailty transitional status in Indonesian elderly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Elderly aged >= 60 years old
- Fit (robust) or pre-frailty;
- Capable to understand and carry-out the instruction.
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in frailty status at 1 year
Time frame: Baseline and at 1 year
Frailty status is divided into Fit (robust), Pre-frail, and Frailty.
4 secondary outcomes
Change from baseline in health-related quality of life at 1 year
Time frame: Baseline and at 1 year
Change from baseline in fall incidence at 1 year
Time frame: Baseline and at 1 year
Change from baseline in hospitality at 1 year
Time frame: Baseline and at 1 year
Change from baseline in mortality at 1 year
Time frame: Baseline and at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
- Background: PubMed 24534517Lee 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.
- Background: PubMed 25348178Laksmi PW. Frailty syndrome: an emerging geriatric syndrome calling for its potential intervention. Acta Med Indones. 2014 Jul;46(3):173-4. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siti Setiati, Prof, MD contact
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
Tirza Tamin, MD, PhD study chair
Department of Rehabilitation & Physical Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Quality of Life, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siti Setiati, Prof, MD (s_setiati@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in frailty status at 1 year (time frame: Baseline and at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02345083, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2015.