Clinical trial NCT02483520: Supporting Family Caregivers With Technology for Dementia Home Care
Official title: Supporting Family Caregivers With Technology for Dementia Home Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Family caregiver
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2015-06-29
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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 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 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, and subsequently evaluate caregiver outcomes. 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. Intervention group videos will be auto-uploaded to a Health Insurance Portability and Accountability Act (HIPAA) secure Internet site for weekly team review with in-home feedback to caregivers in behavior management. The time and attention equivalent control group will receive a weekly phone call from a nurse, but their recorded videos will be held for review and feedback after 3 months.

Study aims are to identify interventions, based on in-home observations, to assist caregivers in behavior management. Between-group effects on outcomes, including PWD disruptive behaviors and caregiver burden and other negative outcomes will be compared using linear mixed modeling. Ease of use and satisfaction, cost-efficiency, and factors influencing likelihood of translation into practice will be evaluated. This tests 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.

Primary outcomes:
measure: Change in Behaviorally Coded Challenging Behaviors (Agitated, Disruptive, Resistive)
timeFrame: 3 months
measure: Change in Caregiver Stress - Reaction to Memory Symptoms (Bother)
timeFrame: Baseline, 1 month, 3 months
measure: Change in Caregiver Stress - Reaction to Depressive Symptoms (Bother)
timeFrame: Baseline, 1 month, 3 months
measure: Change in Caregiver Stress - Desire to Instituionalize
timeFrame: Baseline, 1 month, 3 months
measure: Change in Caregiver Stress - Biological Sensor Data
timeFrame: Baseline, 1 month, 3 months
measure: Change in Caregiver Burden
timeFrame: Baseline, 1 month, 3 months
measure: Change in Caregiver Health and Wellbeing - Depression
timeFrame: Baseline, 1 month, 3 months
measure: Change in Caregiver Health and Wellbeing - Competence
timeFrame: Baseline, 1 month, 3 months
measure: Change in Caregiver Health and Wellbeing - Sleep Disturbance
timeFrame: Baseline, 1 month, 3 months
measure: Change in Caregiver Health and Wellbeing - Medication Use
timeFrame: Baseline, 1 month, 3 months
measure: Change in Caregiver Health and Wellbeing - Confidence in Managing BPSD
timeFrame: Baseline, 3 months
measure: Change in Caregiver Health and Wellbeing - Confidence in Managing Disease Expectations
timeFrame: Baseline, 3 months
measure: Change in Caregiver Health and Wellbeing - Confidence in Managing ADLs (Activities of Daily Living)
timeFrame: Baseline, 3 months
measure: Change in Caregiver Reported Challenging Behaviors - Reaction to Disruptive Symptoms (Bother)
timeFrame: Baseline, 1 month, 3 months
measure: Change in Caregiver Reported Challenging Behaviors - Frequency of Disruptive Behaviors
timeFrame: Baseline, 1 month, 3 months
Secondary outcomes:
measure: Cost for FamTechCare Treatment Compared to Control Group
timeFrame: 3 months
measure: Cost for FamTechCare Treatment Compared to Control Group - ICER
timeFrame: 3 months
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa College of Nursing
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Kristine N Williams, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams K, Arthur A, Niedens M, Moushey L, Hutfles L. In-home monitoring support for dementia caregivers: a feasibility study. Clin Nurs Res. 2013 May;22(2):139-50. doi: 10.1177/1054773812460545. Epub 2012 Sep 20.
citation: Kim S, Shaw C, Williams KN, Hein M. Typology of Technology-Supported Dementia Care Interventions From an In-Home Telehealth Trial. West J Nurs Res. 2019 Dec;41(12):1724-1746. doi: 10.1177/0193945919825861. Epub 2019 Jan 28.