The Progressively Lowered Stress Threshold Model

Sponsor

Aksaray University (Other)

Overall Status

Completed

CT.gov ID

NCT04305652

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Today, with the prolongation of human life, the elderly population has increased and the frequency of diseases seen in old age has increased due to this situation. The most common of these diseases is Alzheimer's disease. The Progressively Lowered Stress Threshold (PLST) is a conceptual model for reducing behavioral symptoms in individuals with dementia. In this study, it is aimed to determine the effect of interventions according to Decreased Stress Threshold Model on the level of neuropsychiatric symptoms and agitation of Alzheimer's patient and caregivers care satisfaction and life satisfaction.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease CAREGİVER	Other: The Progressively Lowered Stress Threshold Model	N/A

Detailed Description

Today, with the prolongation of human life, the elderly population has increased and the frequency of diseases seen in old age has increased due to this situation. The most common of these diseases is Alzheimer's disease. Alzheimer's disease is a progressive neurodegenerative disease which causes cognitive decline and various neuropsychiatric behavioral disorders and disorders in daily living activities. The emergence of these symptoms of Alzheimer's disease leads to an increase in the costs of care provided and a great distress for caregivers. In the literature, it is recommended to use nonpharmacological approaches as the first choice in the treatment of behavioral and psychological symptoms. One of the non-pharmacological approaches is the interventions according to the Progressively Lowered Stress Threshold Model. In this method, taking into account the individuality of the patient, focusing on the interaction of the Alzheimer's patient with the environment and the rearranging of the environment for the reduction of cognitive abilities, focuses on creating a less stressful environment. Since this model uses the steps of the nursing process, home visits are made. This study will be carried out with Alzheimer's patients and caregivers from Aksaray University Education and Research Hospital's Home Health Services unit. In this study, it is aimed to determine the effect of interventions according to Decreased Stress Threshold Model on the level of neuropsychiatric symptoms and agitation of Alzheimer's patient and caregivers care satisfaction and life satisfaction.

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A Randomized Controlled TrialA Randomized Controlled Trial

Masking:

None (Open Label)

Masking Description:

No Intervention: Control group Experimental: Experimental group

Primary Purpose:

Supportive Care

Official Title:

Impact of the Progressively Lowered Stress Threshold Model on Alzheimer's Patient and Caregivers' Care Outcomes: A Randomized Controlled Trial

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Nov 20, 2020

Actual Study Completion Date :

Jan 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group Care providers of Alzheimer's patients aged 65 and over (the standardized Mini-Mental State Examination (MMSE) test cognitive levels score is 19 and below )
Experimental: Experimental group Care providers of Alzheimer's patients aged 65 and over (the standardized Mini-Mental State Examination (MMSE) test cognitive levels score is 19 and below) The caregivers of Alzheimer's patients will be trained for 3 months according to the Progressively Lowered Stress Threshold Model with a home visit.	Other: The Progressively Lowered Stress Threshold Model PLST is a conceptual model for reducing behavioral symptoms in individuals with dementia. The PLST model provides the foundation for a psychoeducational intervention that assists formal and informal caregivers in understanding behaviors and planning care for individuals with dementia. If the model is to be applied at home, at least three home visits are made in line with the listed principles. While making a diagnosis during the first home visit, a maintenance plan for the problems is created in other home visits and the caregiver is trained to implement the care plan. After the home visits, the process is carried out by providing counseling through telephone calls or face-to-face interviews when necessary.

Arm

Intervention/Treatment

No Intervention: Control group

Care providers of Alzheimer's patients aged 65 and over (the standardized Mini-Mental State Examination (MMSE) test cognitive levels score is 19 and below )

Experimental: Experimental group

Care providers of Alzheimer's patients aged 65 and over (the standardized Mini-Mental State Examination (MMSE) test cognitive levels score is 19 and below) The caregivers of Alzheimer's patients will be trained for 3 months according to the Progressively Lowered Stress Threshold Model with a home visit.

Other: The Progressively Lowered Stress Threshold Model

PLST is a conceptual model for reducing behavioral symptoms in individuals with dementia. The PLST model provides the foundation for a psychoeducational intervention that assists formal and informal caregivers in understanding behaviors and planning care for individuals with dementia. If the model is to be applied at home, at least three home visits are made in line with the listed principles. While making a diagnosis during the first home visit, a maintenance plan for the problems is created in other home visits and the caregiver is trained to implement the care plan. After the home visits, the process is carried out by providing counseling through telephone calls or face-to-face interviews when necessary.

Outcome Measures

Primary Outcome Measures

Cohen-Mansfield Agitation Inventory [3 month]
Cohen-Mansfield Agitation Inventory, assessing the frequency of agitation symptoms.The total score that can be taken from the scale ranges between 29-203.

Secondary Outcome Measures

Neuropsychiatric Inventory [3 month]
Neuropsychiatric Inventory used to measure behavioral outcome in particular.If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.
The Turkish version of the Carer's Assessment of Satisfaction Index.There was no cut-point in score interpretation, and a higher total score indicates higher caregiver satisfaction [3 month]
CASI, assessing caregiver satisfaction.
Life Satisfaction scale [3 month]
It evaluates the life satisfaction of caregivers.The higher the score obtained from the scale, the higher the satisfaction.
the standardized Mini-Mental State Examination [1month]
SMMT evaluates cognitive status. Seniors with a SMMT score 19 and below (min.0 - max. 30) were included in the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18 years and above,
Caring for moderate to mild Alzheimer's patients (test cognitive levels score is 19 and below)
Being a close relative of the patient,
Being the primary caregiver,
Having volunteered to participate in the study
There is no problem with communication

Exclusion Criteria:

Younger than 18,
Caring for an advanced Alzheimer's patient
Paid caregiver
Having a communication problem

the standardized Mini-Mental State Examination (MMSE) test cognitive levels score is above 20 points

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aksaray University Health Science Faculty	Aksaray		Turkey	68100

Sponsors and Collaborators

Aksaray University

Investigators

Principal Investigator: Cemile Kütmeç Yılmaz, Aksaray University, Faculty of Health Science, Nursing Department,
Principal Investigator: Kadriye Sayın Kasar, Aksaray University, Faculty of Health Science, Nursing Department,