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

NCT ID: NCT07010874

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Dementia of Alzheimer Type

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
The list of participants for the study will be obtained from the Alzheimer's Social Life Center. The nurse working at the center will create a list of eligible individuals by evaluating caregivers and dementia patients according to the criteria for participation in the study. The list will be forwarded to the independent researcher and the participants will be randomly assigned to the intervention and control groups using the simple random randomization method with the list produced by the independent researcher from the https://www.randomizer.org/ web page.

Study Groups

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intervention

The 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.

Group Type EXPERIMENTAL

REMOTE NURSING INTERVENTIONS BASED ON THE EMPOWERMENT PROCESS MODEL

Intervention Type 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.

control

Dementia patients and their relatives in the control group will continue to receive standard services provided by the Alzheimer's Social Life Center.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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REMOTE NURSING INTERVENTIONS BASED ON THE EMPOWERMENT PROCESS MODEL

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Naile Bilgili

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Metropolitan Municipality Alzheimer's Social Life Center

Ankara, YENİMAHALLE, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 39391088 (View on PubMed)

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.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 35996225 (View on PubMed)

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.

Reference Type RESULT
PMID: 36476485 (View on PubMed)

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

Reference Type RESULT

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.

Reference Type RESULT
PMID: 36482678 (View on PubMed)

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).

Reference Type RESULT

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.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 33711938 (View on PubMed)

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.

Reference Type RESULT
PMID: 33825687 (View on PubMed)

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.

Reference Type RESULT
PMID: 37125549 (View on PubMed)

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.

Reference Type RESULT
PMID: 34623314 (View on PubMed)

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.

Reference Type RESULT
PMID: 28229124 (View on PubMed)

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

Reference Type RESULT

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).

Reference Type RESULT

Adriani, D., Imran, Y., Mawi, M., Amani, P., & Ilyas, E. I. (2020). Effect of Brain Gym® exercises on cognitive function and brain-derived neurotrophic factor plasma level in elderly: a randomized controlled trial. Universa Medicina, 39(1), 34-41.

Reference Type RESULT

Other Identifiers

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GaziU-Aysun ERDAL

Identifier Type: -

Identifier Source: org_study_id

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