NCT04305652

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

11 months

First QC Date

March 10, 2020

Last Update Submit

May 17, 2021

Conditions

Keywords

Alzheimer DiseaseCaregiversCare satisfactionAgitation

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 INTERVENTION

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 group

EXPERIMENTAL

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

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.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Alzheimer DiseasePsychomotor Agitation

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersDyskinesiasNeurologic ManifestationsPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Study Officials

  • Cemile Kütmeç Yılmaz

    Aksaray University, Faculty of Health Science, Nursing Department,

    PRINCIPAL INVESTIGATOR
  • Kadriye Sayın Kasar

    Aksaray University, Faculty of Health Science, Nursing Department,

    PRINCIPAL INVESTIGATOR

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
Model Details: A Randomized Controlled Trial
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

Locations