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Study Protocol
Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE): Study Protocol for a Randomized Controlled Pilot Trial
Tyler Braly
Indiana University School of Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1879-1192
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Pilot and Feasibility Studies.
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
Keywords
Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders
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CURRENT STATUS: Published
Version 2
Posted 23 Sep, 2020
Published
On 11 Jan, 2021
No community comments so far
Editorial decision: Accept
On 13 Dec, 2020
Review #2 received
Received 17 Nov, 2020
Reviewer #2 agreed
On 23 Oct, 2020
Review #1 received
Received 15 Oct, 2020
Reviewers invited
Invitations sent on 14 Oct, 2020
Reviewer #1 agreed
On 14 Oct, 2020
Editor assigned
On 21 Sep, 2020
Submission checks complete
On 20 Sep, 2020
Editor invited
On 20 Sep, 2020
No comments provided
Review #2 received
Received 31 Aug, 2020
Editorial decision: Major revision
On 31 Aug, 2020
Reviewer #3 agreed
On 17 Aug, 2020
Reviewer #2 agreed
On 11 Aug, 2020
Review #1 received
Received 03 Jul, 2020
Reviewers invited
Invitations sent on 26 Jun, 2020
Reviewer #1 agreed
On 26 Jun, 2020
First submitted
On 23 Jun, 2020
Editor assigned
On 23 Jun, 2020
Submission checks complete
On 22 Jun, 2020
Editor invited
On 22 Jun, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Infectious Diseases
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This preprint is under consideration at Pilot and Feasibility Studies. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study Protocol
Technology Intervention to Support Caregiving for Alzheimer's Disease (I-CARE): Study Protocol for a Randomized Controlled Pilot Trial
Tyler Braly
Indiana University School of Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1879-1192
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 2
Posted 23 Sep, 2020
Published
On 11 Jan, 2021
No community comments so far
Editorial decision: Accept
On 13 Dec, 2020
Review #2 received
Received 17 Nov, 2020
Reviewer #2 agreed
On 23 Oct, 2020
Review #1 received
Received 15 Oct, 2020
Reviewers invited
Invitations sent on 14 Oct, 2020
Reviewer #1 agreed
On 14 Oct, 2020
Editor assigned
On 21 Sep, 2020
Submission checks complete
On 20 Sep, 2020
Editor invited
On 20 Sep, 2020
No comments provided
Review #2 received
Received 31 Aug, 2020
Editorial decision: Major revision
On 31 Aug, 2020
Reviewer #3 agreed
On 17 Aug, 2020
Reviewer #2 agreed
On 11 Aug, 2020
Review #1 received
Received 03 Jul, 2020
Reviewers invited
Invitations sent on 26 Jun, 2020
Reviewer #1 agreed
On 26 Jun, 2020
First submitted
On 23 Jun, 2020
Editor assigned
On 23 Jun, 2020
Submission checks complete
On 22 Jun, 2020
Editor invited
On 22 Jun, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Infectious Diseases
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Pilot and Feasibility Studies.
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