AIM 3 Focused Adaptation of a Mobile Caregiver Intervention for Dementia Caregivers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
The goal of this clinical trial is to evaluate usability, feasibility and preliminary efficacy of a mobile telehealth supported behavioral intervention for caregivers of persons with dementia who identify as Hispanic. The main question it aims to answer is: "is a mobile telehealth supported behavioral intervention aimed at supporting caregivers in managing behavioral and psychological symptoms of dementia (BPSD) usable and acceptable and can it preliminarily reduce depressive symptoms and caregiver burden after 6 months of exposure?
Hypothesis: The mobile/telehealth supported intervention will be feasible, as indicated by recruitment and retention rates, data completion, and usability and acceptance measures.
Exploratory Hypothesis: The mobile/telehealth supported intervention will improve caregiver burden and reduce BPSD as measured by the Neuropsychiatric Inventory (NPI-Q).
Researchers will compare an intervention group to a control group to see if there are differences in preliminary outcomes.
Participants will communicate with care coaches through the app and through individualized remotely delivered sessions. The app generates advice cards to develop a care plan that addresses behavioral and psychological symptoms of dementia (BPSD), and tracks cognitive, functional, behavioral and psychological symptoms of the patient and informal caregiver participant's health and quality of life. Individual care coach sessions will focus on management of BPSD and caregiver burden.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Self-identify as Hispanic/Latino and are informal caregivers of a person with dementia.
Able to speak or read English or Spanish
Able to use technology as measured by a technology screening measure.
Age 18 and older
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Brain CareNotes Latino
BehavioralThis is a mobile app supported behavioral intervention. Caregivers/ participants will communicate with care coaches through the app and through individualized remotely delivered sessions. The app generates advice cards to develop a care plan that addresses behavioral and psychological symptoms of dementia (BPSD), and tracks cognitive, functional, behavioral and psychological symptoms of the patient and informal caregiver participant's health and quality of life. Individual care coach sessions will focus on management of BPSD and caregiver burden.
Dementia Care app
Other interventionInformation only app that is freely available in the app store and provides information on dementia care.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Mobile/telehealth supported behavioral interventionExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of the intervention will be measured by recruitment rate
recruitment rate will be calculated by calculating No. approached, No. agreeing, No. consenting, and No. consenting/No. approached.
Time frame
After 6 months participation completed.2
Data completion
Data completion will be collected continually and computed after the final assessment by calculating No. of complete caregiver burden and BPSD assessments per consenting participant/total No. of possible assessments. We will separately compute missing data and attrition for all causes vs. death in the intervention vs. control groups. An enrollment and completion rate of 80% will be considered evidence for successful feasibility.
Time frame
After 6 month participation.3
System Usability Scale (SUS)
The System Usability Scale (SUS) is a 10-item questionnaire scored on a 5-point Likert scale (1 = "Strongly Disagree" to 5 = "Strongly Agree"). Total administration time is 1-2 minutes. The total score range is 0 to 100 ( calculated using a specific scoring formula, not a simple percentage). Identified benchmarks will include mean SUS scores of 68 and above. English and Spanish versions of the SUS will be administered to measure usability
Time frame
The SUS will be administered at baseline, 3 and 6 month follow up appointment.4
Accessibility of Intervention Measure (AIM)
The Acceptability of Intervention Measure (AIM) (developed by Weiner et al., 2017) consists of 4 items rated on a 5-point Likert scale (1 = "Completely Disagree" to 5 = "Completely Agree"). Total administration time is 1-2 minutes. Average score of1 to 5 is calculated by averaging all 4 items. Summed total score range is 4 to 20 (calculated by adding all 4 items together). Higher scores indicate greater intervention acceptability. English and Spanish versions of the AIM will be administered.
Time frame
Baseline, 3 and 6 month follow up appointment.Secondary outcomes
1
Caregiver burden and patient BPSD severity will be measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q)
The Neuropsychiatric Inventory Questionnaire (NPI-Q) is a brief clinical measurement filled out by a caregiver to assess behavioral and psychological symptoms in dementia across 12 domains (e.g., agitation, depression, anxiety, apathy, delusions, hallucinations). It takes about 5-10 minutes to complete. Symptom severity score ranges from 0-36 and the caregiver distress score ranges for 0-60. Higher scores indicate greater behavioral severity and heavier caregiver burden.
Time frame
To be collected at baseline, 3 and 6 month follow up.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov
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