Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06179667 |
| Other study ID # |
--De-Mobile--001 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2024 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
December 2023 |
| Source |
Gulhane Training and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The research shows that the mobile application developed for informal caregivers of people
living with dementia affects caregivers' care burden, quality of life; It was planned as a
mixed-type, randomized controlled study to evaluate its effect on the neuropsychiatric
symptoms of individuals with dementia. The research is planned to be conducted at the
Geriatrics Polyclinic of Gülhane Training and Research Hospital between August 2023 and
December 2025.The population of the research consists of informal caregivers of people living
with dementia who are followed up in the Geriatrics outpatient clinic of Health Sciences
University Gülhane Training and Research Hospital (GTRH). As a result of the power analysis
performed in the G-power 3.1.9.4 package program based on the reference article, it was
calculated that the sample size should be 74 in total, 37 caregivers for each group.
Considering the 15% data loss rate, the sample size was determined as 86 in total, 43
caregivers for each group.t is aimed to develop the mobile application to address the
problems and training needs of informal caregivers regarding the caregiving process. In this
context, in order to determine the needs of caregivers, face-to-face in-depth interviews will
be held with caregivers using the "Semi-Structured Questionnaire for Qualitative Interviews"
at the University of Health Sciences GTRH Geriatrics Department. The content of the mobile
application will be created according to the topics determined as a result of qualitative
research. Examining the Effectiveness of the Developed Mobile Application Individuals who
meet the inclusion criteria and agree to participate in the study will be assigned to the
intervention and control groups by simple randomization method.Caregivers in intervention
group will be encouraged to use the mobile application every day during the implementation of
the research (two months). No treatment will be performed on individuals in the control
group. At the end of the research (2nd month) and 4 weeks after the end of the research (3rd
month), data will be collected electronically through a survey using the Zarit Care Burden
Scale, WHOQOL, Neuropsychiatric Inventory.
Description:
Due to the decrease in cognitive functions in individuals with dementia, individuals
experience difficulties in performing daily living activities. In the later stages of
dementia, behavioral symptoms such as personality changes, hallucinations, and agitation are
also observed. All these cognitive, functional and behavioral symptoms that occur due to
dementia cause the degree of addiction of the individual with dementia to increase. Care of
individuals with dementia is generally provided by informal caregivers, including friends,
neighbors, and family members. The responsibilities undertaken by individuals providing
informal care during the dementia process cause individuals to be affected socially,
physically and economically. All these problems cause care burden on caregivers, leading to a
decrease in their quality of life and involuntary treatment of individuals with dementia,
resulting in more neuropsychiatric syndromes in individuals. In this context, caregivers need
to be supported with practices that will enable them to cope effectively with the caregiving
process. There are non-pharmacological practices such as psychotherapy, support groups,
meditation/mindfulness in the literature to support informal caregivers. However, since these
applications occur within a certain period of time, their effects do not last long .
Caregivers need resources that have a long-lasting effect and that they can benefit from when
they need them. In this context, mobile applications are used in the literature. Mobile
applications are very advantageous applications in terms of cost and time effectiveness that
can enable personalized training opportunities and can be carried with the person 24 hours a
day. There are a limited number of mobile applications in the literature developed for
comprehensive support of informal caregivers.For this reason, this research is planned to
examine the effectiveness of the mobile application developed for informal caregivers of
individuals with dementia.
Place and Time of Research The research is planned to be conducted at the Geriatrics
Polyclinic of Gülhane Training and Research Hospital between August 2023 and December 2025.
Population and Sample of the Research:
The population of the research consists of informal caregivers of people living with dementia
who are followed up in the Geriatrics outpatient clinic of Health Sciences University Gülhane
Training and Research Hospital (GTRH). As a result of the power analysis performed in the
G-power 3.1.9.4 package program based on the reference article, it was calculated that the
sample size should be 74 in total, 37 caregivers for each group. Considering the 15% data
loss rate, the sample size was determined as 86 in total, 43 caregivers for each group.
Research Inclusion Criteria:
- Being over 18 years old
- Reading/writing Turkish
- Being an informal caregiver of an individual diagnosed with dementia by a physician
according to DSM V criteria
- Providing care to the individual with dementia for at least 6 hours a day for at least 1
month
- No neurological or psychiatric problems
- Having a smart phone with internet connection and being able to use the application
program
Criteria for Exclusion from the Research:
- Being a formal caregiver of an individual diagnosed with dementia by a physician
according to DSM V criteria Data Collection Tools
- Form Regarding Sociodemographic and Caregiving Characteristics of Caregivers
- Zarit Care Burden Scale
- World Health Organization Quality of Life Scale Short Form (WHOQOL)
- Neuropsychiatric Inventory (NPE)
- Semi-Structured Questionnaire for Qualitative Interviews
- Quality Criteria for Consumer Health Information (DISCERN) Scale
- Mobile Application Usability Scale Data Collection and Application Stage 1: Development
of Mobile Application It is aimed to develop the mobile application to address the
problems and training needs of informal caregivers regarding the caregiving process. In
this context, in order to determine the needs of caregivers, face-to-face in-depth
interviews will be held with caregivers using the "Semi-Structured Questionnaire for
Qualitative Interviews" at the University of Health Sciences GTRH Geriatrics Department.
The content of the mobile application will be created according to the topics determined
as a result of qualitative research. Technical development of the application will be
carried out by the web application designer. The mobile application will be presented to
expert academicians using the DISCERN scale and the Mobile Application Usability Scale
to be evaluated in terms of the suitability and usability of its content.
Stage 2: Examining the Effectiveness of the Developed Mobile Application Individuals who meet
the inclusion criteria and agree to participate in the study will be assigned to the
intervention and control groups by simple randomization method.
- During the first interview, the consent of individuals in the intervention and control
groups will be obtained and information about the research process will be given.
Face-to-face data will be collected using the Form on Sociodemographic and Caregiving
Characteristics of Caregivers, Zarit Care Burden Scale, WHOQOL, NPE.
Intervention Group;
- Caregivers will be encouraged to use the mobile application every day during the
implementation of the research (two months).
- At the end of the application (2nd month) and 4 weeks after the end of the application
(3rd month), Zarit Care Burden Scale, WHOQOL, NPE; Data will be collected
electronically.
Control Group;
- No treatment will be performed on individuals in the control group.
- At the end of the research (2nd month) and 4 weeks after the end of the research (3rd
month), data will be collected electronically through a survey using the Zarit Care
Burden Scale, WHOQOL, Neuropsychiatric Inventory.
