Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE): Study Protocol for a Randomized Controlled Pilot Trial
Background: Informal caregivers of patients with Alzheimer's disease and related dementias (ADRD) manage a complex spectrum of patient behavioral and psychological symptoms of dementia (BPSD). Mobile health information technologies have quickly become sources for modern social support and chronic disease management. These technologies can improve our understanding of how to care for patients with ADRD and their informal caregivers. A mobile telehealth intervention could help reduce caregiver burden and BPSD.
Methods: This is a pilot randomized controlled trial of 60 dyads of patients living with ADRD and their caregivers, to test the feasibility and estimate the effect of the Brain CareNotes (BCN) mobile telehealth system. Participants will be recruited from two health systems. Participants will be randomly assigned to either the BCN intervention arm or usual care comparator. Data will be collected at baseline, 3- and 6-month follow-up. The primary objectives of this trial are to assess feasibility outcomes: (a) recruitment rate; (b) data completion; (c) BCN usability; (d) BCN acceptance; and (e) BCN use, assessed either on an ongoing basis or at 3- and 6-months post-intervention. A secondary objective was to estimate the intervention’s effects on caregiver burden and patient BPSD outcomes at 3 and 6 months, assessed by the Neuropsychiatric Inventory.
Discussion: The study will assess the intervention feasibility and effect size of the BCN telehealth system as a potentially scalable and lower-cost solution for addressing the ADRD public health crisis.
Trial Registration: Clinical Trials. NCT03119259. Registered 4/18/2017. Clinicaltrials.gov/ct2/show/NCT03119259
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Posted 23 Sep, 2020
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Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE): Study Protocol for a Randomized Controlled Pilot Trial
Posted 23 Sep, 2020
On 11 Jan, 2021
On 13 Dec, 2020
Received 17 Nov, 2020
On 23 Oct, 2020
Received 15 Oct, 2020
Invitations sent on 14 Oct, 2020
On 14 Oct, 2020
On 21 Sep, 2020
On 20 Sep, 2020
On 20 Sep, 2020
Received 31 Aug, 2020
On 31 Aug, 2020
On 17 Aug, 2020
On 11 Aug, 2020
Received 03 Jul, 2020
Invitations sent on 26 Jun, 2020
On 26 Jun, 2020
On 23 Jun, 2020
On 23 Jun, 2020
On 22 Jun, 2020
On 22 Jun, 2020
Background: Informal caregivers of patients with Alzheimer's disease and related dementias (ADRD) manage a complex spectrum of patient behavioral and psychological symptoms of dementia (BPSD). Mobile health information technologies have quickly become sources for modern social support and chronic disease management. These technologies can improve our understanding of how to care for patients with ADRD and their informal caregivers. A mobile telehealth intervention could help reduce caregiver burden and BPSD.
Methods: This is a pilot randomized controlled trial of 60 dyads of patients living with ADRD and their caregivers, to test the feasibility and estimate the effect of the Brain CareNotes (BCN) mobile telehealth system. Participants will be recruited from two health systems. Participants will be randomly assigned to either the BCN intervention arm or usual care comparator. Data will be collected at baseline, 3- and 6-month follow-up. The primary objectives of this trial are to assess feasibility outcomes: (a) recruitment rate; (b) data completion; (c) BCN usability; (d) BCN acceptance; and (e) BCN use, assessed either on an ongoing basis or at 3- and 6-months post-intervention. A secondary objective was to estimate the intervention’s effects on caregiver burden and patient BPSD outcomes at 3 and 6 months, assessed by the Neuropsychiatric Inventory.
Discussion: The study will assess the intervention feasibility and effect size of the BCN telehealth system as a potentially scalable and lower-cost solution for addressing the ADRD public health crisis.
Trial Registration: Clinical Trials. NCT03119259. Registered 4/18/2017. Clinicaltrials.gov/ct2/show/NCT03119259
Figure 1