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Determinants of Cognitive Impairment Among Geriatrics

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ClinicalTrials.gov Identifier: NCT03669536
Recruitment Status : Active, not recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
Hana Old Age Home
Information provided by (Responsible Party):
Anthony Paulo Sunjaya, Faculty of Medicine, Tarumanagara University

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

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

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).


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Determinants of Cognitive Impairment Among Geriatrics in an Indonesian Old Age Home
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Hypertension [ Time Frame: Through study completion, an average of 6 months ]
    Based on blood pressure results and history of hypertension from medical records.

  8. Dyslipidemia [ Time Frame: Through study completion, an average of 6 months ]
    Based on lipid profile results and history of dyslipidemia from medical records.

  9. Anemia [ Time Frame: Through study completion, an average of 6 months ]
    Based on hemoglobin results.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669536


Locations
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Indonesia
Hana Old Age Home
Tangerang, Banten, Indonesia, 15415
Sponsors and Collaborators
Faculty of Medicine, Tarumanagara University
Hana Old Age Home
Investigators
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Principal Investigator: Anthony P Sunjaya Faculty of Medicine, Tarumanagara University

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Responsible Party: Anthony Paulo Sunjaya, Principal Investigator, Faculty of Medicine, Tarumanagara University
ClinicalTrials.gov Identifier: NCT03669536     History of Changes
Other Study ID Numbers: APS007
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anthony Paulo Sunjaya, Faculty of Medicine, Tarumanagara University:
cognitive impairment
dementia
geriatrics

Additional relevant MeSH terms:
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Obesity
Osteoarthritis
Dementia
Cognitive Dysfunction
Dyslipidemias
Blindness
Mobility Limitation
Hearing Loss
Deafness
Obesity, Abdominal
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Lipid Metabolism Disorders
Metabolic Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations