Determinants of Cognitive Impairment Among Geriatrics

September 11, 2018 updated by: Anthony Paulo Sunjaya, Faculty of Medicine, Tarumanagara University

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Banten
      • Tangerang, Banten, Indonesia, 15415
        • Hana Old Age Home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Uncooperative.
  • Incomplete records.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing Impairment
Time Frame: Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months
Vision Impairment
Time Frame: Through study completion, an average of 6 months
Based on physical examination using the Snellen Chart and history of vision impairment from medical records.
Through study completion, an average of 6 months
Diabetes
Time Frame: Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months
Mobility
Time Frame: Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months
Depression
Time Frame: Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months
Sleep Disorder
Time Frame: Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months
Hypertension
Time Frame: Through study completion, an average of 6 months
Based on blood pressure results and history of hypertension from medical records.
Through study completion, an average of 6 months
Dyslipidemia
Time Frame: Through study completion, an average of 6 months
Based on lipid profile results and history of dyslipidemia from medical records.
Through study completion, an average of 6 months
Anemia
Time Frame: Through study completion, an average of 6 months
Based on hemoglobin results.
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Medicine, Tarumanagara University

Collaborators

Hana Old Age Home

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 10, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (Actual)

September 13, 2018

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APS007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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