跳至主要内容
临床试验/CTRI/2022/12/048180
CTRI/2022/12/048180尚未招募不适用

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

THAYAGAM OLD AGE HOME2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2022年12月26日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
220
试验地点
2
主要终点
2.To determine the effectiveness of mental health outreach Initiatives upon cognition and depression among elderly population at selected old age homes, Chennai.

研究概览

简要总结

Statement of the Problem

A study to assess the Effectiveness of Mental HealthOutreach Initiatives upon Cognition and Depression among elderly population atselected old age homes, Chennai.

Objectives

PrimaryObjectives

1.      Toestimate the levels of cognition and depression among elderly population atselected old age homes, Chennai.

2.      Todetermine the effectiveness of mental health outreach Initiatives uponcognition and depression among elderly population at selected old age homes,Chennai.

Secondary Objectives

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

4.      Toassociate the selected variables with cognition and depression among elderlypopulation 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:  Itrefers to improvement in cognition and depression after mental healthinitiatives as evidenced by significant improvement in scores of cognition, andsignificant reduction in scores of depression, after administering theintervention.

Mental health outreach initiatives: It refers to selected models of deliveryof mental health care services which includes reminiscence therapy andvalidation therapy to address the problems related to cognition and depressionamong elderly population

Validationtherapy –It is an intervention that approach towardselderly population with empathy and understanding, reassurance and comfort suchas using clear loving tone of voice, respect and empathy etc. It is given forone month in 8 sessions (2 sessions / week). Each session will be conducted for3 hours (1 hour 30 minutes for individual session and 1 hour 30 minutes forgroup session with 10 minutes break after every 30 minutes session).

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

Cognition: Itrefers to mental process to assess the ability of higher mental functions suchas orientation, recall, attention, verbal recall, reading, writing and copyingamong elderly population which is measured using Mini Mental StatusExamination.

Depression: Itrefers to a mood disorder as manifested by a state of feeling very unhappy, sadnessand hopelessness among elderly population, as measured by Elderly DepressionScale (EDS).

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

Research Methodology

Research approach

Evaluative approach

Research Design

Quasi Experimental –researchdesign

O1      -     O2- O3

O1     X   O2 - O3

Variables

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

•       Dependent Variables: Cognition an Depression

ResearchSetting

Thisstudy will be conducted in selected old age homes, Chennai.

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

•        Sivanandhaold age Home, Chennai -It is a home for the aged male andfemale people who are located at Tambaram, Chennai,. Population

•       Targetpopulation – All elderly population

•       Accessiblepopulation – Elderly population at selected old agehomes

Sample

Thesamples elderly populations who fulfill the inclusion criteria.

SamplingTechnique

Consecutive sampling techniquewill be used to select the participants who are accessible to the researcherand who meet the inclusion criteria of the study .

Sample size

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

90% Power

95% Confidence Interval

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

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

Thesamples size will be 220 elderly populations who fulfill the inclusioncriteria, 110 in control group and 110 in experimental group.

SamplingCriteria

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.

ExclusionCriteria

  1. Elderly population who are not willingto participate in the study.

2.Elderly population who are having problems such as:

a)      Severevisual and hearing problem

b)      SevereCommunication problem

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

d)     Elderlywho are completely dependent on others

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

Developmentand Description of Tools

1. **Section A:**Demographic Variables Proforma

**2.**Performa Section B : Health Variables Proforma

3.      SectionC : **Mini Mental StatusExamination-**Standardizedtool for assessing Cognition: Assessment of orientation, memory, judgment,attention, naming, repetition, stage command, adding, writing and copying etc.

4.      SectionD : **Geriatric depression scale -**Standardizedtool for assessing depression: 15 items, with Yes/ No type responses

Score between 0-4 : No depression

A score of > 5 suggests depression

 PilotStudy

Pilot study will be conductedwith 10% of the total population Permission will be obtained from the concernedauthorities. Pilot study will be conducted using the same tools and proceduresplanned for the main study.

Data Collection

Datawill be collected using predetermined, validated and pretested tools throughface to face interview method. Intervention will be administered to theexperimental and control group will receive routine care. First post test willbe conducted one month after intervention and post test 2 will be conductedafter 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 testthe hypothesis.

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

研究设计

研究类型
Observational

入排标准

年龄范围
60.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •Elderly population who are in the age group of 60-80 years.
  • •Elderly population who are available at the time of data collection.

排除标准

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

结局指标

主要结局

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

时间窗: 1. Post test I will be conducted 1 month after intervention. | 2. Post test II will be conducted 1 month after Post test I

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

时间窗: 1. Post test I will be conducted 1 month after intervention. | 2. Post test II will be conducted 1 month after Post test I

次要结局

  • 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.)

研究者

发起方
THAYAGAM OLD AGE HOME
申办方类型
Other [Old Age]

研究点 (2)

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