The Effect of Wearable Technology-Enhanced Intervention on Family Caregivers

NCT06967688 | Completed DMC

• 1 other identifier: 223S049
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

dementia; caregivers; telehealth; wearable technology

Outcome Measures

Primary Outcomes (2)

• The Revised Scale for Caregiving Self-Efficacy

  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.

  0, 2, and 6 months (measured at baseline, 2 months, and 6 months)

• Short Form 36 Quality of Life Scale

  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.

  0, 2, and 6 months (measured at baseline, 2 months, and 6 months)

Study Arms (2)

Smartwatch-Supported Intervention

EXPERIMENTAL

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

Other: Smartwatch-Supported Caregiver Intervention

Usual Care

NO INTERVENTION

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.

Interventions

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

Smartwatch-Supported Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Izmir University of Economics: lead

Study Sites (1)

Dokuz Eylul University

Balçova, İzmir, 35330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 13, 2025
• Study Start: March 26, 2024
• Primary Completion: September 20, 2024
• Study Completion: December 11, 2024
• Last Updated: May 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)