The Progressively Lowered Stress Threshold Model

Sponsor
Aksaray University (Other)
Overall Status
Completed
CT.gov ID
NCT04305652
Collaborator
(none)
29
Enrollment
1
Location
2
Arms
13
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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

  1. 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

  1. 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.

  2. 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.

  3. Life Satisfaction scale [3 month]

    It evaluates the life satisfaction of caregivers.The higher the score obtained from the scale, the higher the satisfaction.

  4. 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

SiteCityStateCountryPostal Code
1Aksaray University Health Science FacultyAksarayTurkey68100

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,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Güler Duru Aşiret, Principal Investigator, Aksaray University
ClinicalTrials.gov Identifier:
NCT04305652
Other Study ID Numbers:
  • 2018/248
First Posted:
Mar 12, 2020
Last Update Posted:
May 19, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Güler Duru Aşiret, Principal Investigator, Aksaray University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2021