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

NCT02733939 | Completed

• 1 other identifier: 2014-4913
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

technology; informal care; caregiver burden

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months

Secondary Outcomes (12)

• Change from baseline in Quality of Life of the person with dementia at month 3

  3 months

• Change from baseline in Quality of Life of the person with dementia at month 12

  12 months

• Change from baseline in Fear of falling at month 3

  3 months

• Change from baseline in Fear of falling at month 12

  12 months

• Change from baseline in Quality of life of the caregiver at month 3

  3 months

Study Arms (2)

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.

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.

Interventions

Home monitoring kit 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.

Technology intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Memory Clinic, Hospital of Ängelholm

Ängelholm, Skåne County, Sweden

Location

Related Publications (1)

• 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.

  PMID: 28183323 DERIVED

MeSH Terms

Conditions

Dementia; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Carlos Chiatti, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: April 12, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

SE (1)