Development and Effectiveness of a User-centered Mobile Application for Informal Caregivers of People Living With Dementia: Randomized Controlled Trial

NCT06179667 | Completed

• 1 other identifier: --De-Mobile--001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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 Department of Gülhane Training and Research Hospital (GTRH) 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 department. 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), data will be collected electronically through a survey using the Zarit Care Burden Scale, WHOQOL, Neuropsychiatric Inventory.

Conditions

Dementia

Keywords

Dementia; Informal caregiver; Mobile application; Care burden; Quality of life; Neuropsychiatric symptom

Outcome Measures

Primary Outcomes (1)

• caregivers' care burden scores, quality of life scores and neuropsychiatric inventory scores

  Change of caregivers' care burden scores, quality of life scores and neuropsychiatric inventory scores

  At the end of the intervention (2nd month)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Caregivers will be encouraged to use the mobile application every day during the implementation period of the study (two months).

Behavioral: Mobile Application

Control Group

NO INTERVENTION

No treatment will be performed on individuals in the control group.

Interventions

Mobile Application BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over 18 years old
• Reading/writing Turkish
• Being an informal caregiver of an individual diagnosed with Major Neurodegenerative Disorders (dementia) by a physician according to DSM 5 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

You may not qualify if:

• Being a formal caregiver of an individual diagnosed with dementia by a physician according to DSM 5 criteria
• During the two-month application period of the study, I did not log into the mobile application at least once a week.

Sponsors & Collaborators

• Gulhane Training and Research Hospital: lead

Study Sites (1)

Gülhane Research and Training Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dementia; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd Student

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 22, 2023
• Study Start: July 1, 2023
• Primary Completion: June 20, 2025
• Study Completion: July 20, 2025
• Last Updated: February 10, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)