New training helps families handle tough behaviors in dementia and brain injury

NCT ID NCT03734289

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a distance-learning program for family caregivers of people with Alzheimer's dementia or traumatic brain injury. The goal was to reduce care-resistant behaviors like agitation and aggression, and improve quality of life for both patients and families. 88 caregivers participated, learning strategies to manage challenging behaviors and reduce their own stress.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

88 people

The number who actually took part.

Started

Feb 2017

Finished

Aug 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

50 participants with possible or probable Alzheimer's disease dementia (of all severity stages) as defined by the NIA-Alzheimer's Association 2011 criteria will be enrolled, along with a family (i.e., unpaid) caregiver. A second cohort of 25 participants who have sustained moderate to severe TBI as diagnosed by UAB-TBIMS standards (generally Glasgow Coma Scale score of 12 or less at admission, cranial imaging with evidence of acute intracranial trauma, and/or post-traumatic amnesia duration of greater than 24 hours) ≥6 months prior to study entry (and their caregivers) will be enrolled. Entry is dependent on caregiver ratings on at least one of three behavioral domains of the Neuropsychiatric Inventory (NPI): 1) Agitation/Aggression, 2) Disinhibition, 3) Irritability /Lability. Based on standard scoring of the NPI, the caregiver must report all of these for at least one domain: * Frequency of "Often" (several times per week but less than every day) or more, * Severity of "Moderate" (stressful and upsetting; may require specific management) or higher * Distress of "Moderate" (fairly distressing, not always easy to cope with) or higher The caregiver must also report that the adverse behavior is triggered by resistance to care-related activities, e.g., bathing, taking medications, attending health-care appointments, etc. Additional inclusion criteria. * Age ranges AD: ≥ 50 years; TBI ≥ 19; Caregiver ≥18 * Sex distribution: both men and women. * Race: any. * Health: generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane). Vision and hearing (hearing aid permissible) sufficient for compliance with testing procedures, or participants who per clinician criteria are deemed eligible to participate in the study. . * Cognitive function and spoken/written English language skills sufficient to provide valid results on neuropsychological testing, or participants who per clinician criteria are deemed eligible to participate in the study. * Concomitant medications: Subjects may be on stable doses of any psycho-active agents for ≥30 days prior to screening and randomization. * Caregiver: unpaid person who provides support or supervision for at least 1 instrumental activity of daily living for the affected person, with direct contact averaging ≥5 of every 7 days, and ≥21 hours weekly. * Access to high-speed/broad band internet service through home computer capable of operating "Go-to-Meeting" or equivalent conferencing software. Exclusion criteria. * Absence of a reliable caregiver who is willing to participate and comply with protocol responsibilities (described below). * Evidence of other psychiatric/neurologic disorders sufficient to be the primary source of cognitive impairment (i.e., stroke, idiopathic Parkinson's disease, schizophrenia, bipolar or unipolar depression, seizure disorder). * Psychotic features (delusions or hallucinations) not adequately treated or not on stable medical therapy for these conditions 30 days prior to enrollment. * Current or recent (within the past 2 years) history of alcoholism or drug misuse. * Subject and/or caregivers who are unwilling or unable to fulfill the requirements of the study. * Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Alzheimer disease dementia are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.