The Progressively Lowered Stress Threshold Model

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04305652
• Other study ID #: 2018/248
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: May 2021
• Source: Aksaray University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 30, 2021
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• CAREGIVER

Intervention

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.

Locations

Country	Name	City	State
Turkey	Aksaray University Health Science Faculty	Aksaray

Sponsors (1)

Lead Sponsor	Collaborator
Aksaray University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohen-Mansfield Agitation Inventory	Cohen-Mansfield Agitation Inventory, assessing the frequency of agitation symptoms.The total score that can be taken from the scale ranges between 29-203.	3 month
Secondary	Neuropsychiatric Inventory	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.	3 month
Secondary	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	CASI, assessing caregiver satisfaction.	3 month
Secondary	Life Satisfaction scale	It evaluates the life satisfaction of caregivers.The higher the score obtained from the scale, the higher the satisfaction.	3 month
Secondary	the standardized Mini-Mental State Examination	SMMT evaluates cognitive status. Seniors with a SMMT score 19 and below (min.0 - max. 30) were included in the study.	1month