Clinical trial NCT02733939: Technologies to Reduce Caregiver Burden for Informal Caregivers of People With Dementia
Official title: Åldrande: en Innovativ Och teknologistödd hemmiljö för äldre Patienter Med Alzheimers Sjukdom, TECH@HOME.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: technology
informal care
caregiver burden
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: Inclusion Criteria for the person with dementia:

* 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.

Exclusion Criteria for the person with dementia:

* 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;
* 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.

Primary outcomes:
measure: Change from baseline in time spent in informal care at month 3
timeFrame: 3 months
measure: Change from baseline in time spent in informal care at month 12
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline in Quality of Life of the person with dementia at month 3
timeFrame: 3 months
measure: Change from baseline in Quality of Life of the person with dementia at month 12
timeFrame: 12 months
measure: Change from baseline in Fear of falling at month 3
timeFrame: 3 months
measure: Change from baseline in Fear of falling at month 12
timeFrame: 12 months
measure: Change from baseline in Quality of life of the caregiver at month 3
timeFrame: 3 months
measure: Change from baseline in Quality of life of the caregiver at month 12
timeFrame: 12 months
measure: Change from baseline in Caregiver anxiety at month 3
timeFrame: 3 months
measure: Change from baseline in Caregiver anxiety at month 12
timeFrame: 12 months
measure: Change from baseline in Caregiver burden using the Zarit Burden Inventory (ZBI) at month 3
timeFrame: 3 months
measure: Change from baseline in Caregiver burden using the Zarit Burden Inventory (ZBI) at month 12
timeFrame: 12 months
measure: Domestic accidents at month 3
timeFrame: 3 months
measure: Domestic accidents at month 12
timeFrame: 12 months
Other outcomes:
Locations:
city: Ängelholm
country: Sweden
facility: Memory Clinic, Hospital of Ängelholm
state: Skåne
Study officials:
affiliation: Lund University and Italian National Institute on Health and Ageing (INRCA)
name: Carlos Chiatti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.