Alzheimer DiseaseNCT04305652
The Progressively Lowered Stress Threshold Model
A study testing The Progressively Lowered Stress Threshold Model in people with Alzheimer Disease and CAREGİVER, run by Aksaray University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, CAREGİVER
- What is being tested?
- The Progressively Lowered Stress Threshold Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 30 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aksaray University Health Science Faculty
Aksaray, 68100
About this study
Official title: Impact of the Progressively Lowered Stress Threshold Model on Alzheimer's Patient and Caregivers' Care Outcomes: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Alzheimer Disease, CAREGİVER
- Being tested
- The Progressively Lowered Stress Threshold Model
- Keywords
- Alzheimer Disease, Caregivers, Care satisfaction, Agitation
- Medical subject headings
- Alzheimer Disease, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Progressively Lowered Stress Threshold ModelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: The Progressively Lowered Stress Threshold Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 month
Secondary outcomes (4)
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.
Measured: 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
CASI, assessing caregiver satisfaction.
Measured: 3 month
Life Satisfaction scale
It evaluates the life satisfaction of caregivers.The higher the score obtained from the scale, the higher the satisfaction.
Measured: 3 month
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.
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start1 Jan 2020
- Primary completion20 Nov 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güler Duru Aşiret, Aksaray University
- Investigators
- Cemile Kütmeç Yılmaz, Principal investigator, Aksaray University, Faculty of Health Science, Nursing Department,Kadriye Sayın Kasar, Principal investigator, Aksaray University, Faculty of Health Science, Nursing Department,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305652
- Sponsor's protocol ID
- 2018/248
- Status last verified
- May 2021
- First submitted
- 10 Mar 2020
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Progressively Lowered Stress Threshold Model on Alzheimer's Patient and Caregivers' Care Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04305652
- Acronym / sponsor ID
- 2018/248
- Conditions
- Alzheimer Disease, CAREGİVER
- Keywords
- Alzheimer Disease, Caregivers, Care satisfaction, Agitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Aksaray UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: The Progressively Lowered Stress Threshold ModelCare 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Progressively Lowered Stress Threshold ModelPLST 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. | Other | Experimental group |
Primary outcome
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.
4 secondary outcomes
Neuropsychiatric Inventory
Time frame: 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
Time frame: 3 month
Life Satisfaction scale
Time frame: 3 month
the standardized Mini-Mental State Examination
Time frame: 1month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
Related trials for Alzheimer Disease
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
RecruitingPhase 1
An Open Label Dose Escalation Study of VY1706 in Participants With Early Alzheimer's Disease
Alzheimer s Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cemile Kütmeç Yılmaz principal investigator
Aksaray University, Faculty of Health Science, Nursing Department,
Kadriye Sayın Kasar principal investigator
Aksaray University, Faculty of Health Science, Nursing Department,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Progressively Lowered Stress Threshold Model in people with Alzheimer Disease and CAREGİVER, run by Aksaray University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohen-Mansfield Agitation Inventory (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.