DementiaTECH@HOMENCT02733939
Technologies to Reduce Caregiver Burden for Informal Caregivers of People With Dementia
A study testing Home monitoring kit in people with Dementia, run by Lund University at 1 site in Sweden.
Trial summary
This randomized controlled trial aims to recruit a total of 320 dyads composed by persons with dementia living in community settings and their primary informal caregivers. In the intervention group, persons with dementia will have a home monitoring kit installed in the household while participants in the control group… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- Home monitoring kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2016to May 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- a diagnose of major neurocognitive disorders with mild to moderate severity (DSM-5) (following the new diagnostic criteria of the American Psychiatric Association;
- A score between 10 and 24 on the Mini-Mental State Examination (MMSE-SR);
- A score between 1 and 5 in the Global Deterioration Scale (GDS)
- Community dwelling;
- Able to speak and understand Swedish;
- Have at least one informal caregiver.
Who cannot join
- Lack of informed consent;
- Being fully dependent on caregiver support for the Activities of Daily Living;
- Presence of severe diseases associated with a life expectancy of less than 6 months;
- Intention of moving to institutionalized care during the study period;
- Unwillingness to use technological devices for home assistance and safety;
- Being enrolled in another ongoing trial;
Show all 12Show fewer
- Substance use disorder (DSM-5).
- Specific inclusion criteria for the informal caregiver are:
- Lack of informed consent;
- Unwillingness to use technological devices for home assistance and safety;
- Presence of severe diseases associated with a life expectancy of less than 6 months;
- Being already enrolled in another ongoing trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Åldrande: en Innovativ Och teknologistödd hemmiljö för äldre Patienter Med Alzheimers Sjukdom, TECH@HOME.
This randomized controlled trial aims to recruit a total of 320 dyads composed by persons with dementia living in community settings and their primary informal caregivers. In the intervention group, persons with dementia will have a home monitoring kit installed in the household while participants in the control group will receive their usual care. The kit includes home leaving sensors, smoke and water leak sensors, bed sensors as well as automatic lights that monitor the individual's behavior. Alerts (text message and/or phone call) will be sent to the caregiver if anything unusual occurs. All study participants will receive three home visits by project administrators that have received project specific training in order to harmonize data collection. These will take place at enrollment and 3 and 12 months following installation of the home kits. At every home visit, a standardized questionnaire will be administered to all study participants to assess their health, quality of life and resource utilization. The primary outcome of this trial is the amount of informal care support provided by primary informal caregivers to the Person with Dementia.
Read the detailed description
While the enormous technological progress made in recent years has put technologies, such as mobile devices and smart phones, in the reach of many, innovators in dementia care are just starting to explore the full potential of these developments to transform them into valuable products and services for users. There is indeed a lack of studies that evaluate the effectiveness and cost-effectiveness of these new technologically-enriched interventions targeted at people with dementia. Previous large scale evaluations of the impact of telemedicine and telecare, such as the Whole Demonstrator System in the United Kingdom, did not include people with dementia despite Alzheimer's disease being one of the most burdensome diseases in Europe.
This randomized controlled trial aims to evaluate the effects of new technologies on caregiver burden by reducing the time spent in supervision. The trial builds on previous promising results from the UP-TECH project in Italy (https://clinicaltrials.gov/ct2/show/NCT01700556) . The technologies used in TECH@HOME will include similar, but improved, home monitoring kits potentially leading to a greater impact on caregivers' caring conditions. In addition, while the UP-TECH study did not allow the researchers to estimate the impact of the technology as a "stand-alone" intervention (the monitoring kits were only given in combination with case-management support), TECH@HOME will overcome this limitation thanks to the possibility to compare a group of technology users vs. non-users. Results from this intervention in dementia care in Sweden hold the potential to inform regional and national policy makers in Sweden and beyond.
- Conditions
- Dementia
- Being tested
- Home monitoring kit
- Keywords
- technology, informal care, caregiver burden
- Medical subject headings
- Dementia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home monitoring kitDevice
The home monitoring kits notify the caregivers about potentially dangerous situations, such as when the person with dementia:
- leaves the home without notice, since this might occur in a moment of disorientation;
- leaves a water tap open;
- forgets something on the stove;
- gets out of bed during the night and doesn't come back within a certain time interval;
- never goes to the bathroom in 24 hours;
- never opens refrigerator door in 24 hours.
Depending on the personal choice of the study participants, the kit will also :
- automatically turn on a light to help avoid a fall during the night;
- alert the caregiver when the temperature in the house falls or rises excessively;
- act as burglar alarm in some areas of the home.
| Study group | Role | What they receive |
|---|---|---|
| Technology intervention | Experimental | Patients randomized in the intervention group will receive a technical home monitoring kit for 12 months. The kits will be composed of a control unit and a set of sensors that immediately notify caregivers, through their phones, of any potential risks for the person with dementia. The kit will have home leaving sensors, bed occupancy sensors, smoke and water leak sensors, automatic lights, and other interactive functions. These devices will be connected to a single-board microcontroller that will transmit alarm messages to the caregivers in case of need. Receives: Device: Home monitoring kit |
| Usual care | No intervention | Patients receiving usual care, as provided to people with dementia in Southern Sweden can vary. In the target area, people with dementia usually receive comparable pharmaceutical treatment depending on the dementia type, as prescribed by a general practitioner or a specialist at a memory clinic. The social worker from the Municipality ("Biståndshandläggaren") where the person resides, together with the district nurse, have a meaningful role in tailoring the care plan by mediating access to other care services such as respite care homes, home help and (dementia) nurse home visits. Use of such services depends on the specific needs of the person with dementia, which can also be unrelated to dementia, but rather dependent upon concomitant health and social issues. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in time spent in informal care at month 3
The amount of informal care provided by caregivers to the persons with dementia, considered as a proxy of the caregiver burden, will be measured in hours/week and assessed using a specific section of the Resource Utilization in Dementia (RUD) instrument.
Measured: 3 months
Change from baseline in time spent in informal care at month 12
The amount of informal care provided by caregivers to the persons with dementia, considered as a proxy of the caregiver burden, will be measured in hours/week and assessed using a specific section of the Resource Utilization in Dementia (RUD) instrument.
Measured: 12 months
Secondary outcomes (12)
Change from baseline in Quality of Life of the person with dementia at month 3
Quality of life of the person with dementia will be measured using the QOL-AD instrument which has been developed in collaboration with caretakers, caregivers and experts in dementia care to ensure validity. Previous studies suggest that the instrument's validity and reliability are satisfactory in a study population of people with dementia.
Measured: 3 months
Change from baseline in Quality of Life of the person with dementia at month 12
Quality of life of the person with dementia will be measured using the QOL-AD instrument which has been developed in collaboration with caretakers, caregivers and experts in dementia care to ensure validity. Previous studies suggest that the instrument's validity and reliability are satisfactory in a study population of people with dementia.
Measured: 12 months
Change from baseline in Fear of falling at month 3
Fear of falling of the person with dementia will be measured using the 16-item Falls Efficacy Scale-International (FES-I). The evaluation of the Swedish version of the instrument showed high internal reliability also among people with cognitive impairment.
Measured: 3 months
Change from baseline in Fear of falling at month 12
Fear of falling of the person with dementia will be measured using the 16-item Falls Efficacy Scale-International (FES-I). The evaluation of the Swedish version of the instrument showed high internal reliability also among people with cognitive impairment.
Measured: 12 months
Change from baseline in Quality of life of the caregiver at month 3
Quality of life of the caregiver will be assessed using the EQ-5D-3L. This standardized instrument to measure health outcomes has been used and validated in previous Swedish studies.
Measured: 3 months
Change from baseline in Quality of life of the caregiver at month 12
Quality of life of the caregiver will be assessed using the EQ-5D-3L. This standardized instrument to measure health outcomes has been used and validated in previous Swedish studies.
Measured: 12 months
Change from baseline in Caregiver anxiety at month 3
Caregiver anxiety will be assessed using the anxiety component of the Hospital Anxiety and Depression Scale (HADS). HADS is a 14-item scale; seven of the items relate to anxiety and seven relate to depression; each item is a Likert scale rated from 0 to 3, and this means that the overall score for either anxiety or depression will be range from 0 to 21.
Measured: 3 months
Change from baseline in Caregiver anxiety at month 12
Caregiver anxiety will be assessed using the anxiety component of the Hospital Anxiety and Depression Scale (HADS). HADS is a 14-item scale; seven of the items relate to anxiety and seven relate to depression; each item is a Likert scale rated from 0 to 3, and this means that the overall score for either anxiety or depression will be range from 0 to 21.
Measured: 12 months
Change from baseline in Caregiver burden using the Zarit Burden Inventory (ZBI) at month 3
The Zarit Burden Inventory (ZBI) will be used to measure the level of caregiver burden. This is the instrument most consistently used in dementia caregiving research, and it is often used to measure the change of caregiver burden over time, resulting from the progression of the disease severity of the care recipient or from interventions aimed at reducing burden. The revised version of the Zarit with 22 items will be used.
Measured: 3 months
Change from baseline in Caregiver burden using the Zarit Burden Inventory (ZBI) at month 12
The Zarit Burden Inventory (ZBI) will be used to measure the level of caregiver burden. This is the instrument most consistently used in dementia caregiving research, and it is often used to measure the change of caregiver burden over time, resulting from the progression of the disease severity of the care recipient or from interventions aimed at reducing burden. The revised version of the Zarit with 22 items will be used.
Measured: 12 months
Domestic accidents at month 3
This outcome is measured as the total count of domestic accidents, defined as: 1) accidental falls, 2) cuts, 3) episodes of wandering outside the home, 4) burns and fires in the home, 5) flooding which will be assessed using an ad-hoc form.
Measured: 3 months
Domestic accidents at month 12
This outcome is measured as the total count of domestic accidents, defined as: 1) accidental falls, 2) cuts, 3) episodes of wandering outside the home, 4) burns and fires in the home, 5) flooding which will be assessed using an ad-hoc form.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Chiatti, PhD, Principal investigator, Lund University and Italian National Institute on Health and Ageing (INRCA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733939
- Sponsor's protocol ID
- 2014-4913
- Acronym
- TECH@HOME
- Status last verified
- Aug 2019
- First submitted
- 10 Mar 2016
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Malmgren Fange A, Schmidt SM, Nilsson MH, Carlsson G, Liwander A, Dahlgren Bergstrom C, Olivetti P, Johansson P, Chiatti C; TECH@HOME Research Group. The TECH@HOME study, a technological intervention to reduce caregiver burden for informal caregivers of people with dementia: study protocol for a randomized controlled trial. Trials. 2017 Feb 9;18(1):63. doi: 10.1186/s13063-017-1796-8.
PubMed 28183323
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Åldrande: en Innovativ Och teknologistödd hemmiljö för äldre Patienter Med Alzheimers Sjukdom, TECH@HOME.
- ClinicalTrials.gov ID
- NCT02733939
- Acronym / sponsor ID
- TECH@HOME / 2014-4913
- Conditions
- Dementia
- Keywords
- technology, informal care, caregiver burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 12 Apr 2016 (estimated)
- 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 randomized controlled trial aims to recruit a total of 320 dyads composed by persons with dementia living in community settings and their primary informal caregivers. In the intervention group, persons with dementia will have a home monitoring kit installed in the household while participants in the control group will receive their usual care. The kit includes home leaving sensors, smoke and water leak sensors, bed sensors as well as automatic lights that monitor the individual's behavior. Alerts (text message and/or phone call) will be sent to the caregiver if anything unusual occurs. All study participants will receive three home visits by project administrators that have received project specific training in order to harmonize data collection. These will take place at enrollment and 3 and 12 months following installation of the home kits. At every home visit, a standardized questionnaire will be administered to all study participants to assess their health, quality of life and resource utilization. The primary outcome of this trial is the amount of informal care support provided by primary informal caregivers to the Person with Dementia.
Detailed description
While the enormous technological progress made in recent years has put technologies, such as mobile devices and smart phones, in the reach of many, innovators in dementia care are just starting to explore the full potential of these developments to transform them into valuable products and services for users. There is indeed a lack of studies that evaluate the effectiveness and cost-effectiveness of these new technologically-enriched interventions targeted at people with dementia. Previous large scale evaluations of the impact of telemedicine and telecare, such as the Whole Demonstrator System in the United Kingdom, did not include people with dementia despite Alzheimer's disease being one of the most burdensome diseases in Europe.
This randomized controlled trial aims to evaluate the effects of new technologies on caregiver burden by reducing the time spent in supervision. The trial builds on previous promising results from the UP-TECH project in Italy (https://clinicaltrials.gov/ct2/show/NCT01700556) . The technologies used in TECH@HOME will include similar, but improved, home monitoring kits potentially leading to a greater impact on caregivers' caring conditions. In addition, while the UP-TECH study did not allow the researchers to estimate the impact of the technology as a "stand-alone" intervention (the monitoring kits were only given in combination with case-management support), TECH@HOME will overcome this limitation thanks to the possibility to compare a group of technology users vs. non-users. Results from this intervention in dementia care in Sweden hold the potential to inform regional and national policy makers in Sweden and beyond.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology intervention | Experimental | Device: Home monitoring kitPatients randomized in the intervention group will receive a technical home monitoring kit for 12 months. The kits will be composed of a control unit and a set of sensors that immediately notify caregivers, through their phones, of any potential risks for the person with dementia. The kit will have home leaving sensors, bed occupancy sensors, smoke and water leak sensors, automatic lights, and other interactive functions. These devices will be connected to a single-board microcontroller that will transmit alarm messages to the caregivers in case of need. |
| Usual care | No intervention | –Patients receiving usual care, as provided to people with dementia in Southern Sweden can vary. In the target area, people with dementia usually receive comparable pharmaceutical treatment depending on the dementia type, as prescribed by a general practitioner or a specialist at a memory clinic. The social worker from the Municipality ("Biståndshandläggaren") where the person resides, together with the district nurse, have a meaningful role in tailoring the care plan by mediating access to other care services such as respite care homes, home help and (dementia) nurse home visits. Use of such services depends on the specific needs of the person with dementia, which can also be unrelated to dementia, but rather dependent upon concomitant health and social issues. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- a diagnose of major neurocognitive disorders with mild to moderate severity (DSM-5) (following the new diagnostic criteria of the American Psychiatric Association;
- A score between 10 and 24 on the Mini-Mental State Examination (MMSE-SR);
- A score between 1 and 5 in the Global Deterioration Scale (GDS)
- Community dwelling;
- Able to speak and understand Swedish;
Key exclusion criteria (12 listed)
- Lack of informed consent;
- Being fully dependent on caregiver support for the Activities of Daily Living;
- Presence of severe diseases associated with a life expectancy of less than 6 months;
- Intention of moving to institutionalized care during the study period;
- Unwillingness to use technological devices for home assistance and safety;
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 |
|---|---|---|
| Home monitoring kitThe home monitoring kits notify the caregivers about potentially dangerous situations, such as when the person with dementia: * leaves the home without notice, since this might occur in a moment of disorientation; * leaves a water tap open; * forgets something on the stove; * gets out of bed during the night and doesn't come back within a certain time interval; * never goes to the bathroom in 24 hours; * never opens refrigerator door in 24 hours. Depending on the personal choice of the study participants, the kit will also : * automatically turn on a light to help avoid a fall during the night; * alert the caregiver when the temperature in the house falls or rises excessively; * act as burglar alarm in some areas of the home. | Device | Technology intervention |
Primary outcome
Change from baseline in time spent in informal care at month 3
Time frame: 3 months
The amount of informal care provided by caregivers to the persons with dementia, considered as a proxy of the caregiver burden, will be measured in hours/week and assessed using a specific section of the Resource Utilization in Dementia (RUD) instrument.
Change from baseline in time spent in informal care at month 12
Time frame: 12 months
The amount of informal care provided by caregivers to the persons with dementia, considered as a proxy of the caregiver burden, will be measured in hours/week and assessed using a specific section of the Resource Utilization in Dementia (RUD) instrument.
12 secondary outcomes
Change from baseline in Quality of Life of the person with dementia at month 3
Time frame: 3 months
Change from baseline in Quality of Life of the person with dementia at month 12
Time frame: 12 months
Change from baseline in Fear of falling at month 3
Time frame: 3 months
Change from baseline in Fear of falling at month 12
Time frame: 12 months
Change from baseline in Quality of life of the caregiver at month 3
Time frame: 3 months
Change from baseline in Quality of life of the caregiver at month 12
Time frame: 12 months
Change from baseline in Caregiver anxiety at month 3
Time frame: 3 months
Change from baseline in Caregiver anxiety at month 12
Time frame: 12 months
Change from baseline in Caregiver burden using the Zarit Burden Inventory (ZBI) at month 3
Time frame: 3 months
Change from baseline in Caregiver burden using the Zarit Burden Inventory (ZBI) at month 12
Time frame: 12 months
Domestic accidents at month 3
Time frame: 3 months
Domestic accidents at month 12
Time frame: 12 months
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 14 Aug 2019.
- Derived from this study: PubMed 28183323Malmgren Fange A, Schmidt SM, Nilsson MH, Carlsson G, Liwander A, Dahlgren Bergstrom C, Olivetti P, Johansson P, Chiatti C; TECH@HOME Research Group. The TECH@HOME study, a technological intervention to reduce caregiver burden for informal caregivers of people with dementia: study protocol for a randomized controlled trial. Trials. 2017 Feb 9;18(1):63. doi: 10.1186/s13063-017-1796-8.
- Individual participant dataSharing planned: Undecided
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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.
Carlos Chiatti, PhD principal investigator
Lund University and Italian National Institute on Health and Ageing (INRCA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home monitoring kit in people with Dementia, run by Lund University at 1 site in Sweden.
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 6 inclusion and 12 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 14 Aug 2019. 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 Sweden. 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?
Change from baseline in time spent in informal care at month 3 (time frame: 3 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?
On the ClinicalTrials.gov record for NCT02733939, which also lists 1 linked publication.
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 14 Aug 2019.