Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099197
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2023-10-19
Brief Title:
I-CARE 2 Mobile Telehealth to Reduce AlzheimerS-related Symptoms in Hispanic Individuals
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
I-CARE 2 RCT Mobile Telehealth to Reduce AlzheimerS-related Symptoms for Hispanic Caregivers and Patients
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a randomized controlled trial RCT to evaluate usability and acceptability and met and unmet needs from a caregiver intervention app Brain CareNotes among unpaid Hispanic caregivers of patients with dementia Brain CareNotes provides support for management of the behavioral and psychological symptoms of dementia BPSD displayed by care recipients Over 10 months the trial will enroll 40 Hispanic caregivers of community-dwelling patients diagnosed with Alzheimers disease or a related dementia ADRD Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for 12 months with usage reminders
Detailed Description:
This study is a hybrid efficacy-effectiveness RCT to evaluate usability and acceptability and met and unmet needs from a caregiver intervention app Brain CareNotes Over 10 months the trial will enroll 40 Hispanic caregivers Participants will be randomized to use the Brain CareNotes app or an attention control education-only app Dementia Guide Expert for 12 months
The primary objective is to test the the usability and acceptability as well as needs met and unmet by Brain CareNotes among Hispanic caregivers of persons with dementia Barriers in access and acceptance of dementia care resources have been previously identified including gaps in understanding of beliefs or practices between patients and local health systems low health literacy language barriers and other cultural factors These barriers may affect usability and acceptance of interventions Therefore it is hypothesized that average scores on the Simplified Systems Usability Scale will be less than 70 and low acceptance rates will be reported by more than 70 of the Hispanic co-hort These measures will be administered at 3 6 and 12 months
The secondary objective is to examine the needs of Hispanic caregivers that are met and unmet by the Brain CareNotes intervention Information on how unique culturally influenced needs were met or not met by Brain CareNotes will be collected and suggestions for changes to the intervention app will be identified This aim will be addressed qualitatively by providing semi-structured interviews guided by the PROGRESS-PLUS framework to the Hispanic participants who received the Brain CareNotes intervention n20 about their experience with the intervention and suggestions for changes The PROGRESS-PLUS framework addresses cultural and socio-economic factors that should be considered when creating behavioral interventions that are culturally compatible It is expected that responses to interviews will identify themes consistent with a lack of cultural compatibility to factors identified by the PROGRESS-PLUS framework
The primary objective is to test the the usability and acceptability as well as needs met and unmet by Brain CareNotes among Hispanic caregivers of persons with dementia Barriers in access and acceptance of dementia care resources have been previously identified including gaps in understanding of beliefs or practices between patients and local health systems low health literacy language barriers and other cultural factors These barriers may affect usability and acceptance of interventions Therefore it is hypothesized that average scores on the Simplified Systems Usability Scale will be less than 70 and low acceptance rates will be reported by more than 70 of the Hispanic co-hort These measures will be administered at 3 6 and 12 months
The secondary objective is to examine the needs of Hispanic caregivers that are met and unmet by the Brain CareNotes intervention Information on how unique culturally influenced needs were met or not met by Brain CareNotes will be collected and suggestions for changes to the intervention app will be identified This aim will be addressed qualitatively by providing semi-structured interviews guided by the PROGRESS-PLUS framework to the Hispanic participants who received the Brain CareNotes intervention n20 about their experience with the intervention and suggestions for changes The PROGRESS-PLUS framework addresses cultural and socio-economic factors that should be considered when creating behavioral interventions that are culturally compatible It is expected that responses to interviews will identify themes consistent with a lack of cultural compatibility to factors identified by the PROGRESS-PLUS framework
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG078234 | NIH | None | httpsreporternihgovquickSearchR01AG078234 |