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OpenTrials
Completed

NCT Number: NCT06967688

The Effect of Wearable Technology-Enhanced Intervention on Family Caregivers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University

Balçova, İzmir, 35330, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

Smartwatch-Supported Caregiver Intervention

Other

This intervention involved informal caregivers of people with dementia using smartwatches to monitor and manage their own health parameters over an 8-week period. The primary goal was to enhance caregivers' self-efficacy and overall well-being by providing real-time health data through wearable technology. Caregivers were introduced to the smartwatch features, which included heart rate monitoring, inactivity alerts, sleep tracking, stress level monitoring, weight tracking, water intake reminders, and blood oxygen level measurements. Caregivers were instructed to track these parameters using the smartwatch and record their health behaviors in provided diaries.Weekly phone consultations lasting no more than 5 minutes were conducted throughout the 8-week intervention, where caregivers' use of the smartwatch and diaries was reviewed, and general discussions about their health and caregiving experiences took place. The intervention aimed to integrate health self-monitoring into the caregi

Primary outcomes

  1. The Revised Scale for Caregiving Self-Efficacy

    Time frame: 0, 2, and 6 months (measured at baseline, 2 months, and 6 months)

    According to Bandura's 'Social Cognitive Learning Theory' self-efficacy refers to an individual's confidence in their ability to perform a challenging activity. This concept plays a crucial role in managing daily tasks and effectively coping with difficulties. Individuals with high self-efficacy are more motivated and resilient in facing challenges.

  2. Short Form 36 Quality of Life Scale

    Time frame: 0, 2, and 6 months (measured at baseline, 2 months, and 6 months)

    Quality of life was assessed to understand the impact of the intervention on the caregivers' overall well-being. The caregivers' quality of life was measured using a validated scale that evaluated physical health, psychological well-being, social relationships, and environmental factors.

Sponsors and collaborators

Lead sponsor

Izmir University of Economics

Other

Registry information

Official study title

The Effect of Wearable Technology-Enhanced Intervention on Family Caregivers' Self-Efficacy and Quality of Life in Dementia Care

Acronym: dementia care

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 13, 2025
Registry last updated
May 13, 2025

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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