Clinical trial NCT06967688: The Effect of Wearable Technology-Enhanced Intervention on Family Caregivers
Official title: The Effect of Wearable Technology-Enhanced Intervention on Family Caregivers' Self-Efficacy and Quality of Life in Dementia Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: dementia
caregivers
telehealth
wearable technology
Lead sponsor: Izmir University of Economics
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to evaluate the effect of a smartwatch-supported intervention on the self-efficacy and quality of life of informal caregivers providing care to individuals with dementia. Informal caregiving, especially in dementia, poses significant psychological and physical challenges. Low self-efficacy among caregivers can negatively impact their coping skills, health behaviors, and overall quality of life. The intervention used commercially available smartwatches that provided real-time data on physical activity, sleep, and stress levels. These devices were used as part of a 8-week caregiver support program aimed at promoting better self efficacay and quality of life level of caregiver of dementia.

Detailed description: This study aimed to evaluate the effect of a smartwatch-supported intervention on the self-efficacy and quality of life of informal caregivers providing care to individuals with dementia. Informal caregiving, especially in dementia, poses significant psychological and physical challenges. Low self-efficacy among caregivers can negatively impact their coping skills, health behaviors, and overall quality of life. The intervention used commercially available smartwatches that provided real-time data on physical activity, sleep, and stress levels. These devices were used as part of a 8-week caregiver support program aimed at promoting self-care, stress awareness, and time management. This randomized controlled trial involved 44 participants, who were assigned to either the intervention group (smartwatch-supported care) or the control group (usual care). Outcome measures included caregiver self-efficacy and quality of life, assessed both before and after the intervention using validated instruments. The study hypothesized that caregivers in the intervention group would demonstrate improved self-efficacy and better quality of life compared to those in the control group.

Eligibility criteria: Inclusion Criteria:

* a) Able to speak and understand Turkish, b) Primarily responsible for the care of the PwD, c) Provides at least 4 hours of care per day, d) Owns a smartphone (for smartwatch integration), e) Able to use both a mobile phone and a smartwatch (adherence tested through a descriptive characteristic form), f) Willing to participate.

Exclusion Criteria:

* a)Hospitalization of patient or caregiver due to acute condition, b) Caregiver's visual or hearing impairment, c) New diagnosis affecting caregiver's mental health (e.g., depression).

Primary outcomes:
measure: The Revised Scale for Caregiving Self-Efficacy
timeFrame: 0, 2, and 6 months (measured at baseline, 2 months, and 6 months)
measure: Short Form 36 Quality of Life Scale
timeFrame: 0, 2, and 6 months (measured at baseline, 2 months, and 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Balçova
country: Turkey
facility: Dokuz Eylul University
state: İ̇zmi̇r
Study officials:
References: