Technologies to Reduce Caregiver Burden for Informal Caregivers of People With Dementia

NCT ID: NCT02733939

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-05-31

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.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Technology intervention

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.

Group Type: EXPERIMENTAL

Home monitoring kit

Intervention Type: DEVICE

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.

Usual care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Home monitoring kit

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

Exclusion Criteria

• 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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Chiatti, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University and Italian National Institute on Health and Ageing (INRCA)

Locations

Memory Clinic, Hospital of Ängelholm

Ängelholm, Skåne County, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 28183323 (View on PubMed)

Other Identifiers

2014-4913

Identifier Type: -

Identifier Source: org_study_id