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). 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 BrainCare Notes (BCN) mobile telehealth system. Participants will be recruited from two health systems and randomly assigned to either the BCN intervention arm or usual care comparator. Data will be collected at baseline and 3- and 6-month follow-up. The primary outcomes of this trial are: (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. Secondary outcomes are caregiver burden and patient BPSD 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 potential 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
Protocol Version 1: Study # 1606267154
Figure 1
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Received 17 Nov, 2020
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Posted 24 Jun, 2020
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Invitations sent on 26 Jun, 2020
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Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE): Study Protocol for a Randomized Controlled Pilot Trial
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
Posted 24 Jun, 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). 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 BrainCare Notes (BCN) mobile telehealth system. Participants will be recruited from two health systems and randomly assigned to either the BCN intervention arm or usual care comparator. Data will be collected at baseline and 3- and 6-month follow-up. The primary outcomes of this trial are: (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. Secondary outcomes are caregiver burden and patient BPSD 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 potential 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
Protocol Version 1: Study # 1606267154
Figure 1