The Effect of Wearable Technology-Enhanced Intervention on Family Caregivers

NCT ID: NCT06967688

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-26
• Study Completion Date: 2024-12-11

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.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Smartwatch-Supported Intervention

This arm included informal caregivers of people with dementia who participated in a smartwatch-supported intervention. The intervention began with a structured interview session based on the section "Caring for Yourself as a Caregiver" from the book Caring for People with Dementia: Brief Practical Care Tips for Every Caregiver. During the initial session (lasting no more than 45 minutes), caregivers were introduced to the use of smartwatches and their various health-tracking parameters (e.g., heart rate monitoring, inactivity alerts, women's health tracking, weight tracking, blood oxygen levels, stress monitoring, water intake tracking, sleep monitoring). Caregivers were assisted in pairing the smartwatches with their smartphones and were provided with smartwatch diaries to record their health parameters and, optionally, to express their caregiving-related thoughts and feelings. Following the first meeting, weekly phone calls were conducted with each caregiver over an eight-week peri

Group Type: EXPERIMENTAL

Smartwatch-Supported Caregiver Intervention

Intervention Type: 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

Usual Care

This group included informal caregivers of people with dementia who did not receive any additional intervention beyond their usual caregiving routine. They continued their caregiving responsibilities as usual, without the support of wearable technologies or structured training.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Smartwatch-Supported Caregiver Intervention

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Izmir University of Economics

OTHER

Sponsor Role: lead

Responsible Party

Ecem Ozgul

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dokuz Eylul University

Balçova, İzmir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

223S049

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

223S049

Identifier Type: -

Identifier Source: org_study_id