Randomized Controlled Trial On Effectiveness Of Nurse–Led Multifactorial Intervention Program (NLMIP) On Psychological Problems And Well-Being Among Elderly Residing In Selected Assisted Senior Living Facilities

TITLE OF THE STUDY

Randomized Controlled Trial On Effectiveness Of NurseLed Multifactorial Intervention Program NLMIP On Psychological Problems And WellBeing Among Elderly Residing In Selected Assisted Senior Living Facilities

OBJECTIVES

To assess the pre-test psychological problems (stress, anxiety, and depression), well-being (physical, mental, social, emotional, and spiritual), and quality of life among the elderly in experimental and control groups.

To evaluate the effectiveness of the Nurse-Led Multifactorial Intervention Programme (NLMIP) on psychological problems, well-being, and quality of life among the elderly in the experimental group.

To find out the correlation between psychological problems, well-being, and quality of life among the elderly in the experimental group.

To compare the post-test scores of psychological problems and well-being and quality of life among the experimental group and control group.

To find an association between the pre-test scores of psychological problems, well-being, and quality of life among the elderly with the selected demographic variables problems in the experimental and control groups.

HYPOTHESES: All hypotheses will be tested at a 0.05 level of significance.

H01: The mean post-test stress scores will be significantly lesser than the mean pre-test scores stress scores among the elderly in the experimental group.

H02: The mean post-test anxiety scores will be significantly lesser than the mean pre-test anxiety scores among the elderly in the experimental group.

H03: The mean post-test depression scores will be significantly lesser than the mean pre-test depression scores among the elderly in the experimental group.

H04: The mean post-test well-being scores will be significantly higher than the mean pre-test well-being scores among elderly with psychological problems in the experimental group.

H05: The mean post-test quality of life scores will be significantly higher than the mean pre-test quality of life among the elderly with psychological problems in the experimental group.

H06: There will be a significant correlation between stress, anxiety, depression, and well-being among the elderly with psychological problems in the experimental group.

H07: There will be a significant association between the pre-test scores of psychological problems and well-being among the elderly with the selected demographic variables problems in the experimental and control groups.

ASSUMPTIONS & DELIMITATIONS

Assumptions

Old age is the most vulnerable period in which the elderly suffer from psychological problems such as stress, anxiety, and depression.

The level of stress, anxiety, depression, and well-being among the elderly may vary.

Nurse-led multifactorial Intervention Programme (NLMIP) helps the elderly manage psychological problems and improve their well-being.

**Delimitations:**The study will be delimited to:

The study is only done on the elderly people residing in selected senior assisted living facilities in Dehradun.

Study participants are limited to those aged 60 to 75 years.

The NLMIP is limited to 2 weeks duration, for 1 hour.

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RESEARCH METHODOLOGY

Research approach: Quantitative approach.

Trial design including allocation ratio with schematic representation Research design: Randomized Control Trial – Pre-test, Post-test control group design (repeated measure design). The participants will be randomized into either the experimental or control arm through block randomization.

Randomization sequence generation: Permuted block randomization shall be used to allocate the samples into two groups.

Allocation concealment mechanism: Allocation concealment mechanism is the technique of ensuring that implementation of the random allocation sequence occurs without knowledge of which participants and the researcher. The sequentially numbered, opaque, sealed envelopes (SNOSE) technique will be the allocation concealment technique used in this study.

**Blinding:**Considering the nature of the study blinding is not applicable.

Research Settings: The settings of the study will be selected senior assisted living facility at Dehradun, Uttarakhand.

SampleElderly residing in selected senior assisted living facilities, Dehradun, Uttarakhand, who fulfilled the inclusion criteria.

Sampling technique: Non-probability purposive sampling technique was used to select the samples for the study.

Sample size: The total sample size of the study would be 120.

Participant’s eligibility criteria- Inclusion and exclusion criteria

Inclusion criteria

Elderly people living in the assisted living homes of Dehradun.

Elderly between the age group of 60 to 75 years.

Elderly people with mild to moderate levels of stress, anxiety, depression, and low well-being.

Elderly who are willing to attend sessions of Nurse-Led Multifactorial Intervention Programme.

Elderly who can speak and understand Hindi/English.

Exclusion Criteria

Elderly people who have severe depression and neurological disorders.

Elderly people who refuse to engage in the study.

Elderly who are not available during data collection.

Description of the tool: The data collection tool consists of sections A, B, C, and D

1.      Section A: Tool 1: Demographic information and characteristics of the elderly shall be collected using separate data sheets. It consists of 19 items on personal data of elderly residents, such as age, gender, religion, residence, educational status, employment status, monthly income, source of monthly income, previous occupation, socioeconomic status, marital status, no of children, support system, Reason for staying at Senior assisted living facility, Duration of Stay in Senior assisted living facility, Type of Senior assisted living facility, Perceived health status, History of chronic illnesses, substance abuse.

2.      Section B: Tools for measurement of psychological problems –

Tool 2 - Perceived Stress Scale

Tool 3: Generalized Anxiety Disorder Assessment

Tool 4: Brink et al geriatric depression scale Section – C: Tool for measurement of well-being

3.      Section – C: Tool 5: Ryff’s 42-item version of psychological well-being scales (PWB)

4.      Section – D: Tool 6:  For measurement of Quality of Life (WHO QOL – BREF 26).

INTERVENTION: Nurse-Led Multifactorial Intervention Programme :

Relaxation techniques - Jacobson Progressive Muscle Relaxation Techniques

Recreational therapy - Play therapy,

Counselling:

Life review

Psychoeducation

INTERVENTION SCHEDULE

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Plan for Data Collection

The permission for the data collection will be obtained from selected assisted living facilities in Dehradun, Uttarakhand

Informed consent will be obtained from all the participants.

Allocation of the participants to experimental and control groups by randomization

Plan for Data Collection

The permission for the data collection will be obtained from selected assisted living facilities in Dehradun, Uttarakhand

Informed consent will be obtained from all the participants.

Allocation of the participants to experimental and control groups by randomization

Assess the stress, anxiety, depression, and well-being among elderly between 60 to 75 years

Administration of a Nurse-Led Multifactorial Intervention Programme for 14 days, lasting for 1 hour (2 weeks)

Post-test will be conducted in the following days using the same tools,

The 1st post-test will be collected after 1 month of intervention

The 2nd post-test will be collected after 2 months of intervention.

The 3rd post-test will be collected after 3 months of intervention.

Reinforcement therapy: This will be provided after 45 days, through making a daily diary.

Outcome

The primary outcome of the study is to decrease the level of psychological problems and improve the well-being of the elderly.

The secondary outcome will be to improve the quality of life.

Plan for data analysis

Descriptive statistics, frequency percentage, mean, mean percentage, and standard deviation will be used to describe demographic variables and the pre and post-test scores of stress, anxiety, depression, and well-being

Inferential statistics Chi-square test shall be used to find the association of psychological problems and well-being with selected socio-demographic characteristics of the elderly. The correlation between psychological problems and well-being will be estimated using the Karl Pearson Formula. Repeated measures of ANOVA to determine the significance of the difference between the mean pre-test scores of stress, anxiety, depression, and well-being and post-scores 1, 2, and 3.

CTRI Registration the city. The registration in the Clinical Trial Registry - India will be done immediately after the ethical approval.