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Status unknownNCT03669536Updated Sep 13, 2018

Determinants of Cognitive Impairment Among Geriatrics

An observational study in Cognitive Impairment, Dementia and Hearing Impairment, sponsored by Tarumanagara University. Status unknown at 1 site in Indonesia. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-13.

Sponsored by Tarumanagara University · Observational

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
80
Ages
60 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Cognitive Impairment
  • Dementia
  • Hearing Impairment
  • Vision Impairment and Blindness
  • Diabetes
  • Dyslipidemias
  • Obesity
  • Central Obesity
  • Mobility Limitation
  • Osteoarthritis
  • Hypertension
  • Depression

Keywords

  • cognitive impairment
  • dementia
  • geriatrics
03

In context

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's planned enrollment of 80 is below the median of 150 across 997 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Tarumanagara University is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Elderly patients (≥ 60 years of age) currently under the care of an Indonesian Old Age Home.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must be classified as geriatric according to Indonesian Laws (≥ 60 years of age).
  • Consented to participate in this study.

Exclusion criteria

Exclusion Criteria:

  • Uncooperative.
  • Incomplete records.
05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, an average of 6 months

  2. 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.

    Time frame: Through study completion, an average of 6 months

  3. 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.

    Time frame: Through study completion, an average of 6 months

  4. 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.

    Time frame: Through study completion, an average of 6 months

  5. 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.

    Time frame: Through study completion, an average of 6 months

Other outcomes

  1. Hearing Impairment

    Based on physical examination using the Whispered Sound Test from 6 meters and tuning fork test as well as history of hearing impairment from medical records.

    Time frame: Through study completion, an average of 6 months

  2. Vision Impairment

    Based on physical examination using the Snellen Chart and history of vision impairment from medical records.

    Time frame: Through study completion, an average of 6 months

  3. Diabetes

    Based on glycemic profile results and history of diabetes from medical records. Patients are classified as diabetic in accordance to the Indonesian Society of Endocrinology and American Diabetic Association criteria.

    Time frame: Through study completion, an average of 6 months

  4. Mobility

    Based on physical examination, Indonesian Validated Lequesne Index, Barthel Acitivities of Daily Living (ADL), Instrumental ADL and history of arthritis or other pathologies affecting mobility from medical records.

    Time frame: Through study completion, an average of 6 months

  5. Depression

    Based on psychiatric examination, Indonesian Validated Geriatric Depression Scale and Medical Records. A score of 5-9 implies a likelihood of depression, while a score of greater than 10 implies depression.

    Time frame: Through study completion, an average of 6 months

  6. Sleep Disorder

    Based on psychiatric examination, Indonesian Validated Insomnia Severity Index and Medical Records. A score of 8-14 implies mild insomnia, 15-21 intermediate insomnia and 22-28 severe insomnia.

    Time frame: Through study completion, an average of 6 months

  7. Hypertension

    Based on blood pressure results and history of hypertension from medical records.

    Time frame: Through study completion, an average of 6 months

  8. Dyslipidemia

    Based on lipid profile results and history of dyslipidemia from medical records.

    Time frame: Through study completion, an average of 6 months

  9. Anemia

    Based on hemoglobin results.

    Time frame: Through study completion, an average of 6 months

07

Study locations

1 site
  • Hana Old Age Home
    Tangerang, Banten 15415, Indonesia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2017 (actual). Primary completion is estimated for Dec 2018, 16 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2018
First posted
Sep 13, 2018
StartActual
Aug 1, 2017
Primary completionEst.
Dec 2018
CompletionEst.
Dec 2018
Last update
Sep 13, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03669536
Lead sponsor
Tarumanagara University
Collaborators
Hana Old Age Home
Responsible party
Anthony Paulo Sunjaya (Principal Investigator, Tarumanagara University) — Principal investigator
First posted
Sep 13, 2018
Start date
Aug 1, 2017
Primary completion
Dec 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Sep 13, 2018

Study contacts

Anthony P Sunjaya
principal investigator · Tarumanagara University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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