Cognitive ImpairmentNCT03669536
Determinants of Cognitive Impairment Among Geriatrics
An observational study of Cognitive Impairment and Dementia, run by Tarumanagara University at 1 site in Indonesia.
Trial summary
This study aims to explore the determinants of cognitive impairment among Indonesian geriatrics in an Old Age Home. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Dementia, Hearing Impairment
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2017to Dec 2018
- 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: Elderly patients (≥ 60 years of age) currently under the care of an Indonesian Old Age Home.
Who may be able to join
- Must be classified as geriatric according to Indonesian Laws (≥ 60 years of age).
- Consented to participate in this study.
Who cannot join
- Uncooperative.
- Incomplete records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determinants of Cognitive Impairment Among Geriatrics in an Indonesian Old Age Home
This study aims to explore the determinants of cognitive impairment among Indonesian geriatrics in an Old Age Home.
Read the detailed description
Elderly patients (≥ 60 years of age) are enrolled in this study. The inclusion criteria are patients which have consented to take part in the study.
Data such as age, ethnic, education, BMI, waist and hip circumference, blood pressure, hearing impairment, vision impairment, depression, sleep disorder, mobility, hemoglobin levels, glycemic and lipid profile, as well as comorbidities and drugs used were collected from the patients' medical records, laboratory tests and through examination by trained examiners.
Cognition was determined through a combination of several psychiatric examinations using validated instruments namely - MiniCog, Clock Drawing Test, Three Word Recall, Alzheimer's Disease-8 Indonesia (AD-8 INA) Questionnaire and Short Portable Mental Status Questionnaire (SPMSQ).
- Conditions
- Cognitive Impairment, Dementia, Hearing Impairment, Vision Impairment and Blindness, Diabetes, Dyslipidemias
- Keywords
- cognitive impairment, dementia, geriatrics
- Medical subject headings
- Cognitive Dysfunction, Dementia, Hearing Loss, Vision Disorders, Blindness, Diabetes Mellitus, Dyslipidemias, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
MiniCog
Based on psychiatric examination using the Indonesian MiniCog Questionnaire to determine patient's cognitive status. A MiniCog result below 5 implies mild cognitive impairment, while a result below 3 implies dementia.
Measured: Through study completion, an average of 6 months
Clock Drawing Test (CDT)
Based on psychiatric examination using the Indonesian Clock Drawing Test to determine patient's cognitive status. A Clock Drawing Test score below 4 implies mild cognitive impairment.
Measured: Through study completion, an average of 6 months
Three Word Recall
Based on psychiatric examination using the Indonesian Three Word Recall Test to determine patient's cognitive status with resulting score from 0-3. Zero means no words can be recalled by the patient.
Measured: Through study completion, an average of 6 months
Alzheimer Disease-8 Indonesia Questionnaire (AD-8 INA)
Based on interviews with caretakers using the AD-8 INA Questionnaire to determine patient's cognitive status. An AD-8 INA score of 2 or more implies mild cognitive impairment.
Measured: Through study completion, an average of 6 months
Short Portable Mental Status Questionnaire (SPMSQ)
Based on psychiatric examination using the Indonesian SPMSQ to determine patient's cognitive status. An SPMSQ test in which the patient demonstrated more than 3 mistakes implies mild cognitive impairment, whereas a mistake of greater than 8 implies dementia.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Aug 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarumanagara University
- Sponsor type
- University, hospital or other
- Collaborators
- Hana Old Age Home
- Responsible party
- Principal investigator, Anthony Paulo Sunjaya, Tarumanagara University
- Investigators
- Anthony P Sunjaya, Principal investigator, Tarumanagara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669536
- Sponsor's protocol ID
- APS007
- Status last verified
- Sep 2018
- First submitted
- 10 Sep 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Cognitive Impairment Among Geriatrics in an Indonesian Old Age Home
- ClinicalTrials.gov ID
- NCT03669536
- Acronym / sponsor ID
- APS007
- Conditions
- Cognitive Impairment, Dementia, Hearing Impairment, Vision Impairment and Blindness, Diabetes, Dyslipidemias
- Keywords
- cognitive impairment, dementia, geriatrics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tarumanagara UniversityUniversity, hospital or other
- Collaborators
- Hana Old Age Home
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Sep 2018 (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.
This study aims to explore the determinants of cognitive impairment among Indonesian geriatrics in an Old Age Home.
Detailed description
Elderly patients (≥ 60 years of age) are enrolled in this study. The inclusion criteria are patients which have consented to take part in the study.
Data such as age, ethnic, education, BMI, waist and hip circumference, blood pressure, hearing impairment, vision impairment, depression, sleep disorder, mobility, hemoglobin levels, glycemic and lipid profile, as well as comorbidities and drugs used were collected from the patients' medical records, laboratory tests and through examination by trained examiners.
Cognition was determined through a combination of several psychiatric examinations using validated instruments namely - MiniCog, Clock Drawing Test, Three Word Recall, Alzheimer's Disease-8 Indonesia (AD-8 INA) Questionnaire and Short Portable Mental Status Questionnaire (SPMSQ).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly patients (≥ 60 years of age) currently under the care of an Indonesian Old Age Home.
Key inclusion criteria (2 listed)
- Must be classified as geriatric according to Indonesian Laws (≥ 60 years of age).
- Consented to participate in this study.
Key exclusion criteria (2 listed)
- Uncooperative.
- Incomplete records.
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
MiniCog
Time frame: Through study completion, an average of 6 months
Based on psychiatric examination using the Indonesian MiniCog Questionnaire to determine patient's cognitive status. A MiniCog result below 5 implies mild cognitive impairment, while a result below 3 implies dementia.
Clock Drawing Test (CDT)
Time frame: Through study completion, an average of 6 months
Based on psychiatric examination using the Indonesian Clock Drawing Test to determine patient's cognitive status. A Clock Drawing Test score below 4 implies mild cognitive impairment.
Three Word Recall
Time frame: Through study completion, an average of 6 months
Based on psychiatric examination using the Indonesian Three Word Recall Test to determine patient's cognitive status with resulting score from 0-3. Zero means no words can be recalled by the patient.
Alzheimer Disease-8 Indonesia Questionnaire (AD-8 INA)
Time frame: Through study completion, an average of 6 months
Based on interviews with caretakers using the AD-8 INA Questionnaire to determine patient's cognitive status. An AD-8 INA score of 2 or more implies mild cognitive impairment.
Short Portable Mental Status Questionnaire (SPMSQ)
Time frame: Through study completion, an average of 6 months
Based on psychiatric examination using the Indonesian SPMSQ to determine patient's cognitive status. An SPMSQ test in which the patient demonstrated more than 3 mistakes implies mild cognitive impairment, whereas a mistake of greater than 8 implies dementia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
Anthony P Sunjaya principal investigator
Tarumanagara University
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 Cognitive Impairment and Dementia, run by Tarumanagara University 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 2 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: status not confirmed, as of the sponsor's last update on 13 Sep 2018. 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?
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?
MiniCog (time frame: Through study completion, an average of 6 months). The study lists 5 primary outcomes in all. 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 13 Sep 2018.