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Mobile Telehealth for Alzheimer's Disease (I-CARE 2 Trial)
N/A
Recruiting
Led By Richard J Holden, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if the Brain CareNotes app can reduce stress for unpaid caregivers of dementia patients and improve patient symptoms. The app provides practical advice, reminders, and emotional support to help caregivers manage their tasks.
Who is the study for?
This trial is for adults over 18 who are the main unpaid caregivers for someone with Alzheimer's or a related dementia. The caregiver must be able to read English and care for someone who lives in the community and sees their doctor regularly.
What is being tested?
The study tests Brain CareNotes, a mobile app designed to help caregivers manage the stress of caring for someone with dementia. Participants will either use this app or an education-only app as a control, with reminders to use it over a year.
What are the potential side effects?
Since this trial involves using mobile apps, there are no direct medical side effects. However, participants may experience increased stress or emotional discomfort if they find the apps unhelpful or challenging to use.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Caregiver Burden
Patient BPSD
Secondary study objectives
Caregiver Acute Care Utilization
Caregiver Depressive Symptoms
Patient Acute Care Utilization
Other study objectives
App Use
Behavioral Intention Questionnaire
Caregiver Self-efficacy
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Brain CareNotes AppExperimental Treatment1 Intervention
Group II: Attention Control AppActive Control1 Intervention
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for caregiver burden, such as those studied in the Brain CareNotes trial, focus on support and behavioral management. These treatments work by providing caregivers with educational resources, emotional support, and practical strategies to manage the behavioral and psychological symptoms of dementia in their care recipients.
The mechanisms of action include reducing stress through better understanding and management of dementia symptoms, improving coping skills, and providing social support to alleviate feelings of isolation. These interventions are crucial as they help caregivers maintain their mental health and well-being, enabling them to provide better care for their loved ones.
Coping and subjective burden in caregivers of older relatives: a quantitative systematic review.
Coping and subjective burden in caregivers of older relatives: a quantitative systematic review.
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Who is running the clinical trial?
Regenstrief Institute, Inc.OTHER
26 Previous Clinical Trials
98,317 Total Patients Enrolled
2 Trials studying Caregiver Burden
80 Patients Enrolled for Caregiver Burden
National Institute on Aging (NIA)NIH
1,800 Previous Clinical Trials
28,193,326 Total Patients Enrolled
33 Trials studying Caregiver Burden
4,236 Patients Enrolled for Caregiver Burden
Indiana UniversityLead Sponsor
1,042 Previous Clinical Trials
1,316,447 Total Patients Enrolled
8 Trials studying Caregiver Burden
3,934 Patients Enrolled for Caregiver Burden
Richard J Holden, PhDPrincipal InvestigatorIndiana University
2 Previous Clinical Trials
746 Total Patients Enrolled
1 Trials studying Caregiver Burden
40 Patients Enrolled for Caregiver Burden
Malaz Boustani, MDPrincipal InvestigatorIndiana University
2 Previous Clinical Trials
591 Total Patients Enrolled
1 Trials studying Caregiver Burden
40 Patients Enrolled for Caregiver Burden
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am the main caregiver for someone with Alzheimer's or related dementia, and they live at home.I am a caregiver, over 18, and can read and understand English.I am 18 years old or older.I am the main caregiver for someone with Alzheimer's or related dementia.
Research Study Groups:
This trial has the following groups:- Group 1: Attention Control App
- Group 2: Brain CareNotes App
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.