Dementiadementia careNCT06967688
The Effect of Wearable Technology-Enhanced Intervention on Family Caregivers
A study testing Smartwatch-Supported Caregiver Intervention in people with Dementia, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Smartwatch-Supported Caregiver Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Mar 2024to 11 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Wearable Technology-Enhanced Intervention on Family Caregivers' Self-Efficacy and Quality of Life in Dementia Care
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.
Read the 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
- Being tested
- Smartwatch-Supported Caregiver Intervention
- Keywords
- dementia, caregivers, telehealth, wearable technology
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartwatch-Supported Caregiver InterventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0, 2, and 6 months (measured at baseline, 2 months, and 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start26 Mar 2024
- Primary completion20 Sep 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir University of Economics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ecem Ozgul, Izmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967688
- Sponsor's protocol ID
- 223S049
- Other IDs
- 223S049
- Acronym
- dementia care
- Status last verified
- Dec 2024
- First submitted
- 3 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, we do not plan to share individual participant data (IPD) with other researchers. The data will be kept confidential and only used for the purposes of this study.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Wearable Technology-Enhanced Intervention on Family Caregivers' Self-Efficacy and Quality of Life in Dementia Care
- ClinicalTrials.gov ID
- NCT06967688
- Acronym / sponsor ID
- dementia care / 223S049
- Conditions
- Dementia
- Keywords
- dementia, caregivers, telehealth, wearable technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Izmir University of EconomicsUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartwatch-Supported Intervention | Experimental | Other: Smartwatch-Supported Caregiver InterventionThis 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartwatch-Supported Caregiver InterventionThis 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 | Other | Smartwatch-Supported Intervention |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No. No, we do not plan to share individual participant data (IPD) with other researchers. The data will be kept confidential and only used for the purposes of this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartwatch-Supported Caregiver Intervention in people with Dementia, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Revised Scale for Caregiving Self-Efficacy (time frame: 0, 2, and 6 months (measured at baseline, 2 months, and 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.