Frail ElderlyNCT06701045
Prevalence of Malnutrition and Frailty Among the Urban Community Elderly in Bandung
An observational study of Frail Elderly, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
The goal of this observational study is to learn prevalence of malnutrition and frailty in elderly in Community in Bandung. The main question it aims to answer: what is the prevalence of malnutrition and frailty in elderly in Bandung community? Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly
- How many people
- 71 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2022to 31 Mar 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subject were taken form in each district there were a community health center that has an program integrated program specialized for elderly in each subdistrict. We took the subject samples from elderly that regularly visit this subdistrict program.
Who may be able to join
- age above 60 years old
- domicile in Bandung City
- able to mobilize without assistive devices
- able to see and read
- willing to participate in the study
Who cannot join
- history of hospitalization within the previous month
- Mini Mental Status Examination ( MMSE ) score < 24
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to learn prevalence of malnutrition and frailty in elderly in Community in Bandung. The main question it aims to answer:
what is the prevalence of malnutrition and frailty in elderly in Bandung community?
Read the detailed description
The increase in the number and proportion of the elderly population poses various challenges, especially in the health sector. The elderly tend to be more vulnerable to health problems, such as malnutrition and frailty. Data on the prevalence of malnutrition and frailty in the elderly can be used as a basis for taking preventive and treatment measures for both conditions. This study aims to determine the prevalence of malnutrition and frailty in the elderly in the Bandung City community.
Descriptive research with a cross-sectional approach was conducted on 71 elderly participants in the Bandung City community. The sampling method used was consecutive sampling. The study used the Mini Nutritional Assessment-Short Form (MNA-SF) questionnaire to assess malnutrition and the Kihon Checklist (KCL) to assess frailty.
- Conditions
- Frail Elderly
- Keywords
- frail, elderly, malnutrition, community
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly living in community | The inclusion criteria were domicile in Bandung City, able to mobilize without assistive devices, able to see and read and willing to participate in the study after informed consent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty
Frailty is a condition of reduced ability to cope with stressors due to increased vulnerability caused by age-related physiological decline. Frailty score in this study will be measured using Kihon Checklist (KCL) questionnaire that has 24 questions divided into seven categories that are physical strength, nutrition, eating problems, socialization, memory, mood, and lifestyle. The result will bed categorized into not frail (0-3 points), pre-frailty (4-7 points) and frailty (> 8 points).
Measured: On enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Oct 2022
- Primary completion30 Nov 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail ElderlyStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Istingadah Desiana, dr., SpKFR, Ger(K), FIPM(USG), Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701045
- Sponsor's protocol ID
- IKFR-202411.01
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Small sample size
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Malnutrition and Frailty Among the Urban Community Elderly in Bandung
- ClinicalTrials.gov ID
- NCT06701045
- Acronym / sponsor ID
- IKFR-202411.01
- Conditions
- Frail Elderly
- Keywords
- frail, elderly, malnutrition, community
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 22 Nov 2024 (actual)
- 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.
The goal of this observational study is to learn prevalence of malnutrition and frailty in elderly in Community in Bandung. The main question it aims to answer:
what is the prevalence of malnutrition and frailty in elderly in Bandung community?
Detailed description
The increase in the number and proportion of the elderly population poses various challenges, especially in the health sector. The elderly tend to be more vulnerable to health problems, such as malnutrition and frailty. Data on the prevalence of malnutrition and frailty in the elderly can be used as a basis for taking preventive and treatment measures for both conditions. This study aims to determine the prevalence of malnutrition and frailty in the elderly in the Bandung City community.
Descriptive research with a cross-sectional approach was conducted on 71 elderly participants in the Bandung City community. The sampling method used was consecutive sampling. The study used the Mini Nutritional Assessment-Short Form (MNA-SF) questionnaire to assess malnutrition and the Kihon Checklist (KCL) to assess frailty.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly living in community | – | –The inclusion criteria were domicile in Bandung City, able to mobilize without assistive devices, able to see and read and willing to participate in the study after informed consent. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subject were taken form in each district there were a community health center that has an program integrated program specialized for elderly in each subdistrict. We took the subject samples from elderly that regularly visit this subdistrict program.
Key inclusion criteria (5 listed)
- age above 60 years old
- domicile in Bandung City
- able to mobilize without assistive devices
- able to see and read
- willing to participate in the study
Key exclusion criteria (2 listed)
- history of hospitalization within the previous month
- Mini Mental Status Examination ( MMSE ) score < 24
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
Frailty
Time frame: On enrollment
Frailty is a condition of reduced ability to cope with stressors due to increased vulnerability caused by age-related physiological decline. Frailty score in this study will be measured using Kihon Checklist (KCL) questionnaire that has 24 questions divided into seven categories that are physical strength, nutrition, eating problems, socialization, memory, mood, and lifestyle. The result will bed categorized into not frail (0-3 points), pre-frailty (4-7 points) and frailty (> 8 points).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No. Small sample size
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Frail Elderly, run by Universitas Padjadjaran 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 22 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty (time frame: On enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2024.