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The Progressively Lowered Stress Threshold Model

Primary Purpose

Alzheimer Disease, CAREGİVER

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The Progressively Lowered Stress Threshold Model
Sponsored by
Aksaray University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer Disease focused on measuring Alzheimer Disease, Caregivers, Care satisfaction, Agitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aksaray University Health Science Faculty

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Experimental group

Arm Description

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 )

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Life Satisfaction scale
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
SMMT evaluates cognitive status. Seniors with a SMMT score 19 and below (min.0 - max. 30) were included in the study.

Full Information

First Posted
March 10, 2020
Last Updated
May 17, 2021
Sponsor
Aksaray University
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1. Study Identification

Unique Protocol Identification Number
NCT04305652
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
November 20, 2020 (Actual)
Study Completion Date
January 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aksaray University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, CAREGİVER
Keywords
Alzheimer Disease, Caregivers, Care satisfaction, Agitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized Controlled Trial
Masking
None (Open Label)
Masking Description
No Intervention: Control group Experimental: Experimental group
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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 )
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
The Progressively Lowered Stress Threshold Model
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cohen-Mansfield Agitation Inventory
Description
Cohen-Mansfield Agitation Inventory, assessing the frequency of agitation symptoms.The total score that can be taken from the scale ranges between 29-203.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Neuropsychiatric Inventory
Description
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.
Time Frame
3 month
Title
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
Description
CASI, assessing caregiver satisfaction.
Time Frame
3 month
Title
Life Satisfaction scale
Description
It evaluates the life satisfaction of caregivers.The higher the score obtained from the scale, the higher the satisfaction.
Time Frame
3 month
Title
the standardized Mini-Mental State Examination
Description
SMMT evaluates cognitive status. Seniors with a SMMT score 19 and below (min.0 - max. 30) were included in the study.
Time Frame
1month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cemile Kütmeç Yılmaz
Organizational Affiliation
Aksaray University, Faculty of Health Science, Nursing Department,
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kadriye Sayın Kasar
Organizational Affiliation
Aksaray University, Faculty of Health Science, Nursing Department,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aksaray University Health Science Faculty
City
Aksaray
ZIP/Postal Code
68100
Country
Turkey

12. IPD Sharing Statement

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The Progressively Lowered Stress Threshold Model

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