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Dementia of Alzheimer TypeNCT07010874

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

A study testing REMOTE NURSING INTERVENTIONS BASED ON THE EMPOWERMENT PROCESS MODEL in people with Dementia of Alzheimer Type, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dementia of Alzheimer Type
What is being tested?
REMOTE NURSING INTERVENTIONS BASED ON THE EMPOWERMENT PROCESS MODEL
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2025to 31 Dec 2025
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ankara Metropolitan Municipality Alzheimer's Social Life Center

    Ankara, YENİMAHALLE, 06530

Other trials in Turkey (Türkiye)

About this 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

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.

Read the 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.

Being tested
REMOTE NURSING INTERVENTIONS BASED ON THE EMPOWERMENT PROCESS MODEL
Keywords
dementia caregiver, remote nursing, caregiving burden, web-based

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REMOTE NURSING INTERVENTIONS BASED ON THE EMPOWERMENT PROCESS MODELOther

    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.

Study groups in NCT07010874
Study groupRoleWhat they receive
interventionExperimentalThe intervention for this group will last 10 weeks and will be conducted in weekly sessions. The empowerment process model was adopted to guide the intervention process. 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 so that their login details and frequency of visits to the website will be recorded. During the 10-week intervention period, caregivers will be provided with 8 modules of training content.
Receives: Other: REMOTE NURSING INTERVENTIONS BASED ON THE EMPOWERMENT PROCESS MODEL
controlNo interventionDementia patients and their relatives in the control group will continue to receive standard services provided by the Alzheimer's Social Life Center.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Zarit Car Burden Scale

    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.

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

  2. Preparedness for Caregiving Scale

    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.

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

Secondary outcomes (2)

  1. NPE - Neuropsychiatric Inventory

    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.

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

  2. Mini Mental Test

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2025
  2. Study start1 Jun 2025
  3. Primary completion31 Aug 2025
  4. Study completion31 Dec 2025

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07010874
Sponsor's protocol ID
GaziU-Aysun ERDAL
Status last verified
Feb 2025
First submitted
30 May 2025
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • World Health Organization (2023). Dementia. Erişim Tarihi: 02 Aralık 2023, Erişim Adresi: https://www.who.int/news-room/fact-sheets/detail/dementia.

  • Yeh J, Pond B, Beld M, Garcia A, Mauricio J, Mata-Pacheco J, Eldridge C, Ross L. Enhancing Dementia Knowledge and Self-Efficacy of In-Home Supportive Services Caregivers Through Online Training. J Appl Gerontol. 2023 Apr;42(4):617-626. doi: 10.1177/07334648221144023. Epub 2022 Dec 9.

    PubMed 36482678

  • Widyastuti, R. H., Sahar, J., Rekawati, E., & Kekalih, A. (2024). Development of Online Training Modules on Dementia Care at Home for Family Caregivers. The Open Nursing Journal, 18(1).

  • Salehinejad, S., Jannati, N., Azami, M., Mirzaee, M., & Bahaadinbeigy, K. (2024). A web-based information intervention for family caregivers of patients with Dementia: a randomized controlled trial. Journal of Information Science, 50(1), 104-115.

  • Pinyopornpanish M, Pinyopornpanish K, Soontornpun A, Tanprawate S, Nadsasarn A, Wongpakaran N, Wongpakaran T. Perceived stress and depressive symptoms not neuropsychiatric symptoms predict caregiver burden in Alzheimer's disease: a cross-sectional study. BMC Geriatr. 2021 Mar 12;21(1):180. doi: 10.1186/s12877-021-02136-7.

    PubMed 33711938

  • Hong QX, Wang WF, Yang YH, Tung YC, Dai HJ, Hsu WC, Huang LC, Jhang KM. The effectiveness of virtual passport, an app-based intervention, for dementia care. Front Psychiatry. 2024 Sep 26;15:1457923. doi: 10.3389/fpsyt.2024.1457923. eCollection 2024.

    PubMed 39391088

  • Gómez-Morales, A., Coon, D. W., Glinka, A., Stirling, R., Pipe, T., Joseph, R. P., Garcia-Segura, S. (2023). Training alternatives for Alzheimer's disease and related dementia caregivers: Assessing economic and environmental benefits of internet of health things. Journal of Cleaner Production, 418, 138206.

  • Coon DW, Gomez-Morales A. Modifiable Risk Factors for Brain Health and Dementia and Opportunities for Intervention: A Brief Review. Clin Gerontol. 2023 Mar-Apr;46(2):143-154. doi: 10.1080/07317115.2022.2114396. Epub 2022 Aug 22.

    PubMed 35996225

  • Christie HL, Dam AEH, van Boxtel M, Kohler S, Verhey F, de Vugt ME. Lessons Learned From an Effectiveness Evaluation of Inlife, a Web-Based Social Support Intervention for Caregivers of People With Dementia: Randomized Controlled Trial. JMIR Aging. 2022 Dec 7;5(4):e38656. doi: 10.2196/38656.

    PubMed 36476485

  • Biliunaite I, Kazlauskas E, Sanderman R, Truskauskaite-Kuneviciene I, Dumarkaite A, Andersson G. Internet-Based Cognitive Behavioral Therapy for Informal Caregivers: Randomized Controlled Pilot Trial. J Med Internet Res. 2021 Apr 7;23(4):e21466. doi: 10.2196/21466.

    PubMed 33825687

  • Bauernschmidt D, Hirt J, Langer G, Meyer G, Unverzagt S, Wilde F, Wittmann J, Bieber A. Technology-Based Counselling for People with Dementia and Their Informal Carers: A Systematic Review and Meta-Analysis. J Alzheimers Dis. 2023;93(3):891-906. doi: 10.3233/JAD-221194.

    PubMed 37125549

  • Bastoni S, Wrede C, da Silva MC, Sanderman R, Gaggioli A, Braakman-Jansen A, van Gemert-Pijnen L. Factors Influencing Implementation of eHealth Technologies to Support Informal Dementia Care: Umbrella Review. JMIR Aging. 2021 Oct 8;4(4):e30841. doi: 10.2196/30841.

    PubMed 34623314

  • Andrews JS, Desai U, Kirson NY, Enloe CJ, Ristovska L, King S, Birnbaum HG, Fleisher AS, Ye W, Kahle-Wrobleski K. Functional limitations and health care resource utilization for individuals with cognitive impairment without dementia: Findings from a United States population-based survey. Alzheimers Dement (Amst). 2016 Dec 9;6:65-74. doi: 10.1016/j.dadm.2016.11.005. eCollection 2017.

    PubMed 28229124

  • Alzheimer's Association. (2023). 2023 Alzheımer's Dısease Facts and Fıgures Erişim Tarihi: 02 Kasım 2023, Erişim Adresi: https://www.alz.org/media/Documents/alzheimers-facts-and-figures.pdf

  • Akça-Kalem, S., Hanağası, H., Cummings, J. L., & Gürvit, H. (2005, September). Validation study of the Turkish translation of the Neuropsychiatric Inventory (NPI). In 21st international conference of Alzheimer's Disease İnternational, Sept (p. 47).

Questions about this trial

What is this clinical trial studying?

A study testing REMOTE NURSING INTERVENTIONS BASED ON THE EMPOWERMENT PROCESS MODEL in people with Dementia of Alzheimer Type, run by Gazi 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 5 inclusion and 3 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 6 Feb 2026. 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?

Zarit Car Burden Scale (time frame: It will be applied before the start of the program and 15 days after its completion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07010874, which also lists 16 linked publications.

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 6 Feb 2026.

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