FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/12/048180 [Registered on: 16/12/2022] Trial Registered Prospectively
Last Modified On: 15/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of Mental Health Outreach Initiatives upon Cognition and Depression among Elderly population 
Scientific Title of Study   A study to assess the Effectiveness of Mental Health Outreach Initiatives upon Cognition and Depression among Elderly population at selected Old age homes, Chennai.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  CHRISTOBEL JESINTHA J 
Designation  PROFESSOR 
Affiliation  Apollo College of Nursing 
Address  VANAGARAM, AMBATTUR ROAD, CHENNAI 600095
10,GURUSWAMY NAGAR, GOWRIVAKKAM, CHENNAI 600073
Kancheepuram
TAMIL NADU
600095
India 
Phone  9884631351  
Fax  04429765923  
Email  christobeljesintha@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  DRVIJAYALAKSHMI K 
Designation  PROFESSOR 
Affiliation  Apollo College of Nursing 
Address  Apollo College of Nursing VANAGARAM, AMBATTUR ROAD, CHENNAI 600095
10 Madha koil street Thiruverkadu Chennai
Chennai
TAMIL NADU
600095
India 
Phone  9150111120  
Fax  04429765923  
Email  k.vijayalakshmi2000@gmail.com  
 
Details of Contact Person
Public Query
 
Name  CHRISTOBEL JESINTHA J 
Designation  PROFESSOR 
Affiliation  Apollo College of Nursing 
Address  VANAGARAM, AMBATTUR ROAD, CHENNAI 600095
10,GURUSWAMY NAGAR, GOWRIVAKKAM, CHENNAI 600073

TAMIL NADU
600095
India 
Phone  9884631351  
Fax  04429765923  
Email  christobeljesintha@yahoo.com  
 
Source of Monetary or Material Support  
THAYAGAM OLD AGE HOME 
 
Primary Sponsor  
Name  THAYAGAM OLD AGE HOME 
Address  NO 16 PRASANTH COLONY RB AVENUE 5TH STREET KAMARAJAPURAM CHENNAI 600073 
Type of Sponsor  Other [Old Age] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SUDHAKAR  SIVANANDA GURUKULAM  Old Age Home
Chennai
TAMIL NADU 
9444973705

sudhakarrajesh@gmail.com 
MR BHARATH  THAYAGAM OLD AGE HOME CHENNAI  Old Age Home
Chennai
TAMIL NADU 
9841171965

theophiluspriestlyrajan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
INSTITUITIONAL ETHICAL COMMITTEE APOLLO  Approved 
INSTITUITIONALETHICALCOMMITTEE-THAYAGAM OLD AGE HOME AND SIVANANDA GURUKULAM OLD AGE HOME  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ELDERLY POPULATION 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Elderly population who are in the age group of 60-80 years.
2. Elderly population who are available at the time of data collection.
 
 
ExclusionCriteria 
Details  1. Elderly population who are not willing to participate in the study.
2. Elderly population who are having problems such as:
a) Severe visual and hearing problem
b) Severe Communication problem
c) Physically challenged and major health problem, who are unable to participate in the study
d) Elderly who are completely dependent on others
e) Elderly with Covid-19 at the time of data collection.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To estimate the levels of cognition and depression among elderly population at selected old age homes, Chennai.
2. To determine the effectiveness of mental health outreach Initiatives upon cognition and depression among elderly population at selected old age homes, Chennai.
 
1. Post test I will be conducted 1 month after intervention.
2. Post test II will be conducted 1 month after Post test I  
 
Secondary Outcome  
Outcome  TimePoints 
3. To find the correlation between cognition and depression among elderly population at selected old age homes
4. To associate the selected variables with cognition and depression among elderly population at selected old age homes.
 
POST TEST I ONE MONTH AFTER INTERVENTION
POST TEST II ONE MONTH AFTER POST TEST I 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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)   26/12/2022 
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="1"
Months="1"
Days="10" 
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)?  

Response - NO
Brief Summary  

Statement of the Problem

A study to assess the Effectiveness of Mental Health Outreach Initiatives upon Cognition and Depression among elderly population at selected old age homes, Chennai.

Objectives

Primary Objectives

1.      To estimate the levels of cognition and depression among elderly population at selected old age homes, Chennai.

2.      To determine the effectiveness of mental health outreach Initiatives upon cognition and depression among elderly population at selected old age homes, Chennai.

Secondary Objectives

3.      To find the correlation between cognition and depression among elderly population at selected old age homes

4.      To associate the selected variables with cognition and depression among elderly population at selected old age homes.

Hypotheses

  1. H1 - There will be a significant difference in cognition and depression between control group and experimental group of the elderly population in pre test and post tests
  2. H2 -There will be a correlation between cognition and depression between control group and experimental group of the elderly population in pre test and post tests
  3. H3 - There will be a significant association of selected background variables with cognition and depression in the experimental and control group.

Operational Definitions

      Effectiveness:  It refers to improvement in cognition and depression after mental health initiatives as evidenced by significant improvement in scores of cognition, and significant reduction in scores of depression, after administering the intervention.

      Mental health outreach initiatives:  It refers to selected models of delivery of mental health care services which includes reminiscence therapy and validation therapy to address the problems related to cognition and depression among elderly population

Validation therapy –It is an intervention that approach towards elderly population with empathy and understanding, reassurance and comfort such as using clear loving tone of voice, respect and empathy etc. It is given for one month in 8 sessions (2 sessions / week). Each session will be conducted for 3 hours (1 hour 30 minutes for individual session and 1 hour 30 minutes for group session with 10 minutes break after every 30 minutes session).

Reminiscence therapy- It is an intervention that uses all the senses and improves self esteem and provides elderly population with a sense of fulfillment and comfort as they look back to their lives such as listening to favorite music, foods, look at photos, painting, pottery and other crafts etc. It is given for one month in 8 sessions (2 sessions / week). Each session will be conducted for 3 hours (1 hour 30 minutes for individual session and 1 hour 30 minutes for group session with 10 minutes break after every 30 minutes session).

    Cognition: It refers to mental process to assess the ability of higher mental functions such as orientation, recall, attention, verbal recall, reading, writing and copying among elderly population which is measured using Mini Mental Status Examination.

           Depression: It refers to a mood disorder as manifested by a state of feeling very unhappy, sadness and hopelessness among elderly population, as measured by Elderly Depression Scale (EDS).

           Elderly Population: It refers to the people aged 60-80 years who are living in old age homes.

Research Methodology

Research approach

                   Evaluative approach

Research Design

                   Quasi Experimental –research design

                                                    O1      -     O2 - O3

                                                    O1     X    O2 - O3


Variables

•       Independent Variable: Mental health outreach initiatives (Validation and Reminiscence therapy)

•       Dependent Variables: Cognition an Depression

Research Setting

This study will be conducted in selected old age homes, Chennai.

•         Thayagam Old age HOme -It is a home for the aged people, which are located at Sembakkam, Chennai.

•         Sivanandha old age Home, Chennai -It is a home for the aged male and female people who are located at Tambaram, Chennai,. Population

•       Target population – All elderly population

•       Accessible population – Elderly population at selected old age homes

Sample

The samples elderly populations who fulfill the inclusion criteria.

Sampling Technique

             Consecutive sampling technique will be used to select the participants who are accessible to the researcher and who meet the inclusion criteria of the study .

Sample size

Sample size is estimated based on the previous study findings using power analysis.

90% Power

95% Confidence Interval

Required sample size (open epi) was 88 ie., 44 for control group and 44 for experimental group.

  However considering the possible attrition and better generalization 220 samples will be included in this study- 110 for control and 110 for experimental group.

The samples size will be 220 elderly populations who fulfill the inclusion criteria, 110 in control group and 110 in experimental group.

Sampling Criteria

           Inclusion Criteria

1. Elderly population who are in the age group of 60-80 years.

2. Elderly population who are available at the time of data collection.

Exclusion Criteria

      1. Elderly population who are not willing to participate in the study.

2. Elderly population who are having problems such as:

a)      Severe visual and hearing problem

b)      Severe Communication problem

c)      Physically challenged and major health problem, who are unable to participate in the study

d)     Elderly who are completely dependent on others

e)      Elderly with Covid-19 at the time of data collection.

Development and Description of Tools

1.      Section A:  Demographic Variables Proforma

2.      Performa Section B : Health Variables Proforma

3.      Section C : Mini Mental Status Examination- Standardized tool for assessing Cognition: Assessment of orientation, memory, judgment, attention, naming, repetition, stage command, adding, writing and copying etc.

4.      Section D : Geriatric depression scale - Standardized tool for assessing depression: 15 items, with Yes/ No type responses

Score between 0-4 : No depression

A score of > 5 suggests depression

 

 Pilot Study

              Pilot study will be conducted with 10% of the total population Permission will be obtained from the concerned authorities. Pilot study will be conducted using the same tools and procedures planned for the main study.

Data Collection

            Data will be collected using predetermined, validated and pretested tools through face to face interview method. Intervention will be administered to the experimental and control group will receive routine care. First post test will be conducted one month after intervention and post test 2 will be conducted after 2 months of intervention.

Data Analysis

Descriptive statistics

The descriptive statistical analysis includes frequencies, percentages, means, and Standard deviation.

Inferential statistics

Inferential statistics measured like independent’T’ test used test the hypothesis.

The chi-square test will be used to find the association between the demographic variables.


 
Close