Determinants of Cognitive Impairment Among Geriatrics

Obesity Clinical Trial

Official title:

Determinants of Cognitive Impairment Among Geriatrics in an Indonesian Old Age Home

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03669536
• Other study ID #: APS007
• Status: Active, not recruiting
• Start date: August 1, 2017
• Est. completion date: December 2018

Study information

• Verified date: September 2018
• Source: Faculty of Medicine, Tarumanagara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blindness
• Central Obesity
• Cognitive Dysfunction
• Cognitive Impairment
• Deafness
• Dementia
• Depression
• Diabetes
• Dyslipidemias
• Hearing Impairment
• Hearing Loss
• Hypertension
• Mobility Limitation
• Obesity
• Obesity, Abdominal
• Osteoarthritis
• Vision Impairment and Blindness

Locations

Country	Name	City	State
Indonesia	Hana Old Age Home	Tangerang	Banten

Sponsors (2)

Lead Sponsor	Collaborator
Faculty of Medicine, Tarumanagara University	Hana Old Age Home

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Through study completion, an average of 6 months
Other	Vision Impairment	Based on physical examination using the Snellen Chart and history of vision impairment from medical records.	Through study completion, an average of 6 months
Other	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.	Through study completion, an average of 6 months
Other	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.	Through study completion, an average of 6 months
Other	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.	Through study completion, an average of 6 months
Other	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.	Through study completion, an average of 6 months
Other	Hypertension	Based on blood pressure results and history of hypertension from medical records.	Through study completion, an average of 6 months
Other	Dyslipidemia	Based on lipid profile results and history of dyslipidemia from medical records.	Through study completion, an average of 6 months
Other	Anemia	Based on hemoglobin results.	Through study completion, an average of 6 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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