Clinical trial NCT07010874: THE EFFECT OF REMOTE NURSING INTERVENTIONS BASED ON THE EMPOWERMENT PROCESS MODEL ON PEOPLE WITH DEMENTIA AND THEIR FAMILY CAREGIVERS: A MIXED METHODS STUDY
Official title: THE EFFECT OF REMOTE NURSING INTERVENTIONS BASED ON THE EMPOWERMENT PROCESS MODEL ON PEOPLE WITH DEMENTIA AND THEIR FAMILY CAREGIVERS: A MIXED METHODS STUDY
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia Patients and Caregivers
Keywords: dementia caregiver
remote nursing
caregiving burden
web-based
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed as a mixed methods research. In the quantitative part of this study, it was planned as a randomized controlled pretest-posttest (parallel) study to evaluate the effect of remote nursing interventions based on the empowerment model on individuals with dementia and family caregivers. After the completion of the quantitative part of the qualitative part of the study, in-depth semi-structured interviews will be conducted to determine the experiences and opinions of individuals with dementia and family caregivers regarding remote nursing interventions based on the empowerment model.
Primary purpose: OTHER

Brief summary: In this study, it is planned to evaluate the effect of remote nursing interventions based on the empowerment model on individuals with dementia and family caregivers. It was designed as a mixed method research. It chose explanatory sequential mixed methods design as a mixed method type. The research will be conducted at the Alzheimer's Social Life Center affiliated to Ankara Metropolitan Municipality between June 01 and December 31, 2025. The quantitative part of the study was planned in a randomized controlled pretest-posttest (parallel) study design. The study will be conducted with 30 caregivers in the intervention group and 30 in the control group. Descriptive Information Form, Zarit Care Burden Scale, Caregiver Readiness Scale, Mini Mental Test and NPE - Neuropsychiatric Inventory will be used as data collection tools. The intervention period was determined as 10 weeks. Remote nursing interventions based on the model will be carried out through the web page named "Take Care of Yourself". Dementia patients and their relatives in the control group will continue to receive standard services provided by the Alzheimer Social Life Center. One week after the end of the intervention, the data collection tools will be applied again by the nurse at the center to the dementia patients and caregivers in both groups. Quantitative data will be evaluated using appropriate statistics in SPSS 23.0 package program. After the quantitative part of the study is completed, the qualitative part will be applied. The qualitative part was designed in a descriptive phenomenological design. In-depth individual interviews will be conducted with individuals who meet the inclusion criteria. A semi-structured interview form will be used in individual interviews. When it is decided that data saturation has been reached, the data collection phase of the research will be terminated. Data analysis will be carried out with the content analysis approach. The data will be analyzed using the MAXQDA 20 program. After the data collected from the qualitative and quantitative phases are analyzed separately, the findings of the two phases will be integrated in the interpretation phase.

Detailed description: In the study, the intervention will be carried out in weekly sessions. A empowerment process model has been adopted to guide the intervention process. Prior to the study, a pilot study will be conducted at a different Alzheimer's Social Life Centre with dementia caregivers who meet the study participation criteria in order to test the usability of the developed website and determine the comprehensibility of the content of the training modules prepared for the maintenance process.

Eligibility criteria: Inclusion Criteria:

* Are 18 years of age or older,
* Are literate,
* Are able to use the internet,
* Have a close relative diagnosed with dementia related to Alzheimer's disease and are in the early stages of dementia (Mini Mental Test score between 19 and 24).
* Informal caregivers who have been providing care to a person with dementia for at least 6 months will be included in the study.

Exclusion Criteria:

* Individuals with physical (vision and hearing impairments) or psychological (schizophrenia, bipolar disorder, intellectual disabilities, etc.) conditions that prevent them from using the program,
* Caregivers of individuals with dementia diagnosed with Alzheimer's disease, who also have a life-threatening illness (central nervous system infections, organic brain damage, COPD, cancer, etc.) that increases the care burden and are currently undergoing active treatment for this illness,
* Caregivers of individuals with dementia who live in long-term care facilities or multiple homes and do not have a primary caregiver will not be included in the study.

Primary outcomes:
measure: Zarit Car Burden Scale
timeFrame: It will be applied before the start of the program and 15 days after its completion.
measure: Preparedness for Caregiving Scale
timeFrame: It will be administered before the start of the program and 15 days after its completion.
Secondary outcomes:
measure: NPE - Neuropsychiatric Inventory
timeFrame: It will be administered before the start of the application and 15 days after the end of the application.
measure: Mini Mental Test
timeFrame: It will be administered before the start of the application and 15 days after the end of the application.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Metropolitan Municipality Alzheimer's Social Life Center
state: Yeni̇mahalle
Study officials:
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