N/A N=189 Randomized Supportive Care

Supporting Family Caregivers With Technology for Dementia Home Care

Dementia

Bottom Line

View on ClinicalTrials.gov: NCT02483520 ↗

Enrolled (actual)

189

Serious AEs

0.5%

Results posted

Nov 2020

Primary outcome: Primary: Change in Behaviorally Coded Challenging Behaviors (Agitated, Disruptive, Resistive) — 784; 253 Care videos submitted

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: FamTechCare (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Kansas Medical Center
Primary completion: Jan 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Behaviorally Coded Challenging Behaviors (Agitated, Disruptive, Resistive)	784; 253	—
PRIMARY Change in Caregiver Stress - Reaction to Memory Symptoms (Bother)	22.8; 17.5; 20.5; 18.9; 19.8; 17.4	.977
PRIMARY Change in Caregiver Stress - Reaction to Depressive Symptoms (Bother)	8.3; 6.9; 6.8; 7.6; 7.3; 6.1	.812
PRIMARY Change in Caregiver Stress - Desire to Instituionalize	1.5; 1.7; 1.6; 1.9; 2.0; 2.5	—
PRIMARY Change in Caregiver Stress - Biological Sensor Data	—	—
PRIMARY Change in Caregiver Burden	28.0; 27.2; 27.6; 26.6; 26.6; 27.4	.343
PRIMARY Change in Caregiver Health and Wellbeing - Depression	16.0; 12.0; 14.5; 12.8; 13.8; 12.3	.012 sig
PRIMARY Change in Caregiver Health and Wellbeing - Competence	3.7; 3.9; 4.0; 3.8; 4.1; 3.5	.033 sig
PRIMARY Change in Caregiver Health and Wellbeing - Sleep Disturbance	7.5; 7.0; 7.3; 6.9; 7.3; 6.8	—
PRIMARY Change in Caregiver Health and Wellbeing - Medication Use	1; 1; 2; 3; 1; 3	—
PRIMARY Change in Caregiver Health and Wellbeing - Confidence in Managing BPSD	1.7; 2.3; 2.6; 2.8	.211
PRIMARY Change in Caregiver Health and Wellbeing - Confidence in Managing Disease Expectations	2.3; 2.2; 2.9; 2.8	.476
PRIMARY Change in Caregiver Health and Wellbeing - Confidence in Managing ADLs (Activities of Daily Living)	2.3; 2.2; 2.8; 2.6	.677
PRIMARY Change in Caregiver Reported Challenging Behaviors - Reaction to Disruptive Symptoms (Bother)	6.1; 4.0; 5.3; 5.1; 5.4; 4.9	.432
PRIMARY Change in Caregiver Reported Challenging Behaviors - Frequency of Disruptive Behaviors	2.40; 1.88; 2.45; 2.39; 2.40; 2.29	.255
SECONDARY Cost for FamTechCare Treatment Compared to Control Group	175.00; 0; 174.16; 0; 86.63; 76.02	—
SECONDARY Cost for FamTechCare Treatment Compared to Control Group - ICER	18.51; 36.38	—

Summary

This clinical trial will test the FamTechCare intervention that uses multidisciplinary professional guidance based on in-home video monitoring to support family caregivers in managing challenging behaviors of persons with dementia (PWD). Families provide the majority of care for PWD at home. However the stress of caregiving is so significant that it increases caregiver morbidity and mortality. Stress is magnified by disruptive behaviors in PWD that frequently lead to nursing home placement. In-home video monitoring allows experts to assess behaviors of PWD and to identify antecedents, recommend specific interventions. FamTechCare uses new technology to link family caregivers to experts for guidance in managing disruptive behaviors, supporting continued care at home while reducing the negative effects of caregiving. Caregiver-PWD dyads (N=88) will be randomly assigned to intervention or control groups. Both groups will record behaviors during daily care for 3 months using a home monitoring unit. Notably, this new technology captures 3-5 minutes prior to the behavior, thus recording behavior triggers and precursors. Caregivers record care situations they select and upload videos to a secure site. The expert team will review intervention group videos weekly and will provide individualized feedback for improving care to caregivers in the home. The control group caregivers will receive a weekly phone call and advice from a nurse, but their recorded videos will be held for review and individualized feedback provided after 3 months. Study aims are to use observation to assist caregivers in behavior management. Effects on disruptive behaviors and caregiver burden and other negative outcomes will be compared. Investigators will evaluate ease of use and satisfaction, cost-efficiency, and factors influencing likelihood of translation into practice. This is the first study to test new technology for direct observation and immediate feedback to empower families to manage PWD behaviors at home while reducing caregiver stress and morbidity. Technology links caregivers to individualized expert guidance, acknowledging the importance and burden of their role. This study addresses NIH missions and the 2012 National Plan to Address Alzheimer's disease goals, integrating strategies to promote adoption and use of aging services technologies in interventions that will reduce negative caregiver outcomes, a growing public health problem.

Eligibility Criteria

Inclusion Criteria

Person caring for someone with a diagnosis of Alzheimer's disease or other dementia at home.

Exclusion Criteria

Exclusion criteria include Huntington's disease, alcohol-related dementia, schizophrenia, manic-depressive disorder, deafness, and mental retardation.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02483520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.