NCT03669536

Brief Summary

This study aims to explore the determinants of cognitive impairment among Indonesian geriatrics in an Old Age Home.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

1.3 years

First QC Date

September 10, 2018

Last Update Submit

September 11, 2018

Conditions

Cognitive ImpairmentDementiaHearing ImpairmentVision Impairment and BlindnessDiabetesDyslipidemiasObesityCentral ObesityMobility LimitationOsteoarthritisHypertensionDepression

Keywords

cognitive impairmentdementiageriatrics

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Through study completion, an average of 6 months

Other Outcomes (9)

  • Hearing Impairment

    Through study completion, an average of 6 months

  • Vision Impairment

    Through study completion, an average of 6 months

  • Diabetes

    Through study completion, an average of 6 months

  • +6 more other outcomes

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Uncooperative.
  • Incomplete records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hana Old Age Home

Tangerang, Banten, 15415, Indonesia

Location

MeSH Terms

Conditions

Cognitive DysfunctionDementiaHearing LossVision DisordersBlindnessDiabetes MellitusDyslipidemiasObesityObesity, AbdominalMobility LimitationOsteoarthritisHypertensionDepression

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsEye DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism DisordersOverweightOvernutritionNutrition DisordersBody WeightArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesVascular DiseasesCardiovascular DiseasesBehavioral SymptomsBehavior

Study Officials

  • Anthony P Sunjaya

    Tarumanagara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 10, 2018

First Posted

September 13, 2018

Study Start

August 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

September 13, 2018

Record last verified: 2018-09

Locations

ID(1)