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Completed

NCT Number: NCT07010874

THE EFFECT OF REMOTE NURSING INTERVENTIONS BASED ON THE EMPOWERMENT PROCESS MODEL ON PEOPLE WITH DEMENTIA AND THEIR FAMILY CAREGIVERS

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.

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Key information

Conditions

Dementia of Alzheimer Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Metropolitan Municipality Alzheimer's Social Life Center

Ankara, YENİMAHALLE, 06530, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

REMOTE NURSING INTERVENTIONS BASED ON THE EMPOWERMENT PROCESS MODEL

Other

The duration of the intervention is determined as 10 weeks. Distance nursing interventions based on the model will be carried out through a web page called "Take Care of Yourself". Each participant will have a unique username and password while using the website, so that login information and the frequency of visiting the website will be recorded. During the 10-week intervention period, caregivers will be provided with 8 modules of training content. In the first session of the intervention, the website will be introduced, personal goals will be set and the session will be completed with the planning of the next week. personal goals will be set, and in the last session of the intervention, feedback will be given to the individuals by the researcher regarding the achievement of their personal goals and their ability to cope with future difficulties.

Primary outcomes

  1. Zarit Car Burden Scale

    Time frame: It will be applied before the start of the program and 15 days after its completion.

    Scale, developed by Zarit and Zarit in 1990, has a Cronbach's alpha value of 0.91. The validity and reliability of the Turkish version were established by Özer, Yurttaş, and Akyıl (2012). It consists of 18 statements that determine the impact of caregiving on an individual's life. The scale is evaluated based on the total score. The score range is 0-72. A higher score indicates a higher caregiving burden.

  2. Preparedness for Caregiving Scale

    Time frame: It will be administered before the start of the program and 15 days after its completion.

    Scale was developed by Archbold and Stewart (1986). Its validity and reliability for the Turkish society were established by Karaman and Karadakovan (2015). . The scale consists of eight items and an additional item that asks caregivers about the area in which they would like to be better prepared to provide care.

Secondary outcomes

  1. NPE - Neuropsychiatric Inventory

    Time frame: It will be administered before the start of the application and 15 days after the end of the application.

    Turkish standardization and validity reliability study was conducted in 2005. It is conducted retrospectively (up to the last month) in the form of an interview with a person who is in daily contact with the patient and has witnessed the patient's behavior. Symptoms of NPE include: delusions, hallucinations, agitation/aggression, dysphoria/depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, abnormal motor behaviors, sleep/nighttime behaviors, and changes in appetite/eating.

  2. Mini Mental Test

    Time frame: It will be administered before the start of the application and 15 days after the end of the application.

    This test will be used to assess the cognitive health of dementia patients.It will also be used to identify participants who are in the early stages of dementia.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 8, 2025
Registry last updated
Feb 6, 2026

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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