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CTRI Number  CTRI/2019/03/018190 [Registered on: 20/03/2019] Trial Registered Prospectively
Last Modified On: 20/03/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Descriptive 
Study Design  Other 
Public Title of Study   A study to assess cognitive impairment among elderly in the selected community, Kancheepuram district, Tamil nadu. 
Scientific Title of Study   "Assessment of cognitive impairment among elderly in a selected community, Kancheepuram district, Tamil Nadu" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1229-5263  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aravindhan B 
Designation  B.Sc Nursing Student 
Affiliation  Chettinad college of Nursing 
Address  Chettinad college of Nursing CARE Kelambakkam Kanchipuram district

Kancheepuram
TAMIL NADU
603103
India 
Phone  7550234027  
Fax    
Email  aravindhanbala1999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rogina J S Savarimuthu 
Designation  Associate Professor 
Affiliation   
Address  Chettinad college of Nursing CARE Kelambakkam Kanchipuram district

Kancheepuram
TAMIL NADU
603103
India 
Phone  9442039514  
Fax    
Email  roginajerome@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rogina J S Savarimuthu 
Designation  Associate Professor 
Affiliation  Chettinad college of Nursing 
Address  Chettinad college of Nursing CARE Kelambakkam Kanchipuram district

Kancheepuram
TAMIL NADU
603103
India 
Phone  9442039514  
Fax    
Email  roginajerome@gmail.com  
 
Source of Monetary or Material Support  
Chettinad College of Nursing CARE 
 
Primary Sponsor  
Name  Chettinad College of Nursing 
Address  Chettinad College of Nursing CARE Kelambakkam Chennai 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Chettinad College of Nursing  Chettinad College of Nursing CARE Kelambakkam Chennai 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Rogina J S Savarimuthu  Kokilamedu Village  Homes in the village
Kancheepuram
TAMIL NADU 
9442039514

roginajerome@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Cognitive impairment among elderly 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Those who are willing to participate. 
 
ExclusionCriteria 
Details  Those with known mental or psychological disorder. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
BRIEF COGNITIVE RATING SCALE (BCRS)  1 - Normal
2 - Very mild
3 - Mild
4 - Moderate
5- Moderately Severe
6 - Sever
7 - Very severe 
 
Secondary Outcome  
Outcome  TimePoints 
Elderly  a)60-40 Years
b)70-80 Years
c)80-90 Years
d) 90 Years 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

OBJECTIVE:

To asses cognitive impairment among elderly in the selected community.

To associate cognitive impairment with selected demographic variables.

BACKGROUND OF THE STUDY:

A prevalence of dementia and cognitive impairment were 6.5 per 100 and 5.1 per 100. Cognitive impairment is very common in the younger old age (under 70 years of age). were as dementia becomes predominant after 75 years of age. Both conditions are strongly related to the educational level.

The world health organization predicts that by 2025 about 75% of the extremities 1.2 billion people aged 60 years and older will reside in developing countries. It is estimated that the number of people living with dementia will almost double every 20 years to 42.3 million in 2020 and 801.1 million in 2040.

In addition to these cognitive impairments, elderly can develop impairments to motor skills including reduced levels of flexibility, agility, strength, balance and aerobic resistance. Such impairments can directly affect the elderly’s ability to perform activities of daily living.

This study aims to identify the cognitive and functional impairment of elderly and to share information about the it and its management.

 

REVIEW OF LITERATURE: 

The prevalence of cognitive impairment was 3.5 % it was higher in rural (2.3%) then in urban population (1.3%) with a rural /urban prevalence ratio (PR) of 1.8 (95% CL 0.6/5.7). in the logistic recreation model, old-old, literate and widowed showed a higher probability of cognitive impairment. It was not associate with use of alcohol. Cigarette smoking or under nutrition (Deepak Sharma, Salig Ram Mazta et al; 2013) .

Peracino (2014) reported cognitive impairment and dementia are linked to progressive reduction in cognitive abilities, functional independence, social relationships. In the last decades, there has been increasing evidence that the association of cognitive impairment with hearing loss supports the need for medical research and clinical answers in this area.

Penny A. Dacks, Joshua J.Carman et al (2016) reported that common diseases like diabetes, hypertension, and atrial fibrillation are probable risk factors for dementia, suggesting that their treatments may influence the risk and rate of cognitive and functional decline. Moreover, specific therapies and medications may affect long-term brain health through mechanisms that are independent of their primary indication. While surgery, benzodiazepines, and anti-cholinergic drug may accurate decline or even raise the risk of dementia, other medication act directly on the brain to potentially slow the pathology that underlies Alzheimer’s and other dementia. In other words, the functional cognitive decline in vulnerable patient may be influence by the choice of treatment for other vulnerable population. Some therapeutic however may altered specific aspects of aging biology either through direct effects or indirect via management of comorbidities linked to accelerated aging.

METHODOLOGY:

Research approach:

Descriptive approach.

Research design:

Non experimental, descriptive research design.

Research setting:

The study will be conducted among individuals above the age 60 who are residing at Kokilamedu village, Kanchipuram district.

Population:

Individuals above the age 60 who are residing at Kokilamedu village, Kanchipuram district.

Study Object:

To asses cognitive and functional impairment among elderly in the selected community

To associate cognitive and functional impairment with selected demographic variables.

OPERATIONAL DEFINITION

Cognitive impairment: Is the impairment of concentration, recent memory,past memory, orientation, functioning and self-care as measured by Brief Cognitive Rating Scale

Elderly: Are individuals above the age 60 who are residing at Kokilamedu village during the time of data collection.

Sample size:

   The sample size will range between 71 and 81.

n= 4pq/d2

p=5%

d=5

n=76

 

Subject Selection: 

    Elderly above the age 60 year residing in Kokilamedu village during the time of data collection.

A. Inclusion criteria:

Those who are 60 years and older.

Those who are willing to participate.

B. Exclusion criteria:

Those with known mental or psychological disorder.

Instruments

Demographic Data

Brief Cognitive Rating Scale

Duration of the study

One week

Statistical Methods

Descriptive statistics like frequency distribution, percentage, mean, standard deviation & inferential statistics like chi-square test will be used to analyze the data.

ETHICAL CONSIDERATION:

Department clearance was obtained from department of mental health nursing and  Chettinad College of Nursing. Formal permission was be obtained from the Principal, Chettinad college of nursing. UG Committee clearance and institutional ethical committee clearance was obtained from Chettinad Academy of Research and Education.  Formal consent will be obtained from the study samples before collecting the information.

 
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