The Progressively Lowered Stress Threshold Model
Impact of the Progressively Lowered Stress Threshold Model on Alzheimer's Patient and Caregivers' Care Outcomes: A Randomized Controlled Trial
1 other identifier
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable alzheimer-disease
Started Jan 2020
Shorter than P25 for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 10, 2020
CompletedFirst Posted
Study publicly available on registry
March 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2021
CompletedMay 19, 2021
May 1, 2021
11 months
March 10, 2020
May 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Neuropsychiatric Inventory
3 month
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
Life Satisfaction scale
3 month
the standardized Mini-Mental State Examination
1month
Study Arms (2)
Control group
NO INTERVENTIONCare 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 group
EXPERIMENTALCare 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aksaray University Health Science Faculty
Aksaray, 68100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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,
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- No Intervention: Control group Experimental: Experimental group
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 10, 2020
First Posted
March 12, 2020
Study Start
January 1, 2020
Primary Completion
November 20, 2020
Study Completion
January 30, 2021
Last Updated
May 19, 2021
Record last verified: 2021-05