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Behavioural Intervention

Mobile Telehealth for Alzheimer's Disease

N/A

Recruiting

Led By Malaz Boustani, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will test if a mobile health app can reduce the burden of unpaid Hispanic caregivers of dementia patients and improve BPSD symptoms in the care recipients.

Who is the study for?

This trial is for unpaid Hispanic caregivers, aged 18 or older, who look after someone with Alzheimer's disease or a related dementia and live in the community. Caregivers must be English literate and able to use a mobile touchscreen device. Those caring for individuals in nursing homes or participating in another conflicting clinical trial cannot join.Check my eligibility

What is being tested?

The study tests Brain CareNotes, a mobile app designed to help manage caregiver burden and symptoms of dementia patients. Participants will either use this app or an education-only app as control for one year, with reminders to ensure consistent usage.See study design

What are the potential side effects?

Since this trial involves using mobile health applications rather than medications, traditional side effects are not expected. However, users may experience stress or frustration if they encounter difficulties using the technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Caregiver Burden

Patient BPSD

Secondary outcome measures

Caregiver Acute Care Utilization

Caregiver Depressive Symptoms

Patient Acute Care Utilization

Other outcome measures

App Use

Behavioral Intention Questionnaire

Caregiver Self-efficacy

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Brain CareNotesExperimental Treatment1 Intervention

The Brain CareNotes mobile telehealth app is used by unpaid caregivers for BPSD management. It includes remote communication with an external human support person-a care coach-as well as features for users to independently perform health-related activities.

Group II: Attention Control AppActive Control1 Intervention

Dementia Guide Expert provides education only and no interactive BPSD management support, coaching, assessment, or external response. It contains "evidence-based expert information on what dementia is, types, contributing factors, risks, symptoms, stages, diagnosis, tests, treatment, management, communication techniques, and links to resources and support services."

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

981,722 Total Patients Enrolled

7 Trials studying Caregiver Burden

3,566 Patients Enrolled for Caregiver Burden

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,845 Total Patients Enrolled

24 Trials studying Caregiver Burden

2,411 Patients Enrolled for Caregiver Burden

Malaz Boustani, MDPrincipal InvestigatorIndiana University

2 Previous Clinical Trials

711 Total Patients Enrolled

1 Trials studying Caregiver Burden

160 Patients Enrolled for Caregiver Burden

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the number of participants for this medical experiment?

"Affirmative, details on clinicaltrials.gov demonstrate that this study is actively recruiting individuals for inclusion. It was first posted on September 26th 2023 and last modified October 19th of the same year. Forty participants are required to be sourced at one specific medical centre."

Answered by AI

Are there available positions for participants in this experiment?

"Affirmative. According to the sources hosted on clinicaltrials.gov, this research is presently enrolling participants. The trial was published on September 26th 2023 and recently revised on October 19th 2023; 40 patients are needed from a single site for study completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms in Hispanic Individuals

Miriam J Rodriguez 2023. "I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms in Hispanic Individuals". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06099197.

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