Clinical trial NCT04305652: The Progressively Lowered Stress Threshold Model
Official title: Impact of the Progressively Lowered Stress Threshold Model on Alzheimer's Patient and Caregivers' Care Outcomes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
CAREGİVER
Keywords: Alzheimer Disease
Caregivers
Care satisfaction
Agitation
Lead sponsor: Aksaray University
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cohen-Mansfield Agitation Inventory
timeFrame: 3 month
Secondary outcomes:
measure: Neuropsychiatric Inventory
timeFrame: 3 month
measure: 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
timeFrame: 3 month
measure: Life Satisfaction scale
timeFrame: 3 month
measure: the standardized Mini-Mental State Examination
timeFrame: 1month
Other outcomes:
Locations:
city: Aksaray
country: Turkey
facility: Aksaray University Health Science Faculty
Study officials:
affiliation: Aksaray University, Faculty of Health Science, Nursing Department,
name: Cemile Kütmeç Yılmaz
role: PRINCIPAL_INVESTIGATOR
affiliation: Aksaray University, Faculty of Health Science, Nursing Department,
name: Kadriye Sayın Kasar
role: PRINCIPAL_INVESTIGATOR
References: