What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for reducing caregiver burden, such as psychoeducation, counseling, and stress management techniques, generally have minimal side effects. Psychoeducation and counseling can sometimes lead to emotional distress as caregivers confront challenging feelings and situations. Stress management techniques, including mindfulness and relaxation exercises, are typically well-tolerated but may initially cause frustration or anxiety as caregivers learn new skills. Overall, these interventions are considered safe and beneficial for improving caregiver well-being.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of caregiver burden. However, interventions similar to the Brain CareNotes trial, which focuses on support and behavioral management, often include non-pharmacological approaches such as counseling, support groups, and educational programs. These interventions aim to reduce stress and improve the well-being of caregivers. While pharmacological treatments for the caregivers themselves are not common, medications like cholinesterase inhibitors and memantine are approved for managing symptoms in dementia patients, indirectly alleviating some caregiver burden by improving patient outcomes.

What other types of research exist?

Promising alternatives to Brain CareNotes for managing caregiver burden in 2024 include: 1) Mobile health applications with integrated AI for personalized support and real-time monitoring, 2) Virtual reality (VR) platforms for stress reduction and mental health support, 3) Telehealth services offering comprehensive caregiver training and counseling, 4) Wearable devices that track patient health metrics and alert caregivers to potential issues, and 5) Online support groups and forums facilitated by healthcare professionals for peer support and resource sharing.

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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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Brain CareNotes AppExperimental Treatment1 Intervention

Group II: Attention Control AppActive Control1 Intervention

Do I qualify?Apply below to find out

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.

Find a Location

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

1,733 Previous Clinical Trials

28,054,803 Total Patients Enrolled

28 Trials studying Caregiver Burden

2,964 Patients Enrolled for Caregiver Burden

Indiana UniversityLead Sponsor

1,019 Previous Clinical Trials

1,114,015 Total Patients Enrolled

8 Trials studying Caregiver Burden

3,934 Patients Enrolled for Caregiver Burden

Media Library

Brain CareNotes Clinical Trial Eligibility Overview. Trial Name: NCT05733520 — N/A

Caregiver Burden Research Study Groups: Attention Control App, Brain CareNotes App

Caregiver Burden Clinical Trial 2023: Brain CareNotes Highlights & Side Effects. Trial Name: NCT05733520 — N/A

Brain CareNotes 2023 Treatment Timeline for Medical Study. Trial Name: NCT05733520 — N/A

~133 spots leftby Jul 2027

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