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NCT Number: NCT04305652

The Progressively Lowered Stress Threshold Model

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.

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Key information

Conditions

Alzheimer Disease Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Brain Diseases CAREGİVER Central Nervous System Diseases Dementia Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aksaray University Health Science Faculty

Aksaray, 68100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Progressively Lowered Stress Threshold Model

Other

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 outcomes

  1. Cohen-Mansfield Agitation Inventory

    Time frame: 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 outcomes

  1. Neuropsychiatric Inventory

    Time frame: 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

    Time frame: 3 month

    CASI, assessing caregiver satisfaction.

  3. Life Satisfaction scale

    Time frame: 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

    Time frame: 1month

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

Sponsors and collaborators

Lead sponsor

Aksaray University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Mar 12, 2020
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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