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Improving Family Quality of Life Through Training to Reduce Care-Resistant Behaviors by People With AD and TBI

NCT ID: NCT03734289

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2021-08-31

Brief Summary

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To reduce care resistant behaviors (CRB) among people with dementia residing in nursing homes, to a distance-learning education, training, and coaching program for family caregivers of people with dementia or TBI; assess the efficacy of the intervention for reducing frequency or severity of CRB-triggered symptoms of agitation, aggression, and irritability; assess the efficacy of the intervention for improving quality of life of patients, caregivers, and families; and determine how patient and caregiver characteristics influence the effectiveness of the intervention.

5\. Evaluate how the intervention affects the health care costs of people with dementia or TBI.

Detailed Description

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To address the previously unanswered question of whether theoretically-driven caregiver education and coaching in nonpharmacologic approaches to reduce care resistant behaviors as a trigger of behavioral and psychiatric symptoms of dementia (BPSD) and neuropsychiatric symptoms after Traumatic Brain Injury (NPTBI) will improve caregiver burden, quality of life (QOL), and related outcomes of patients with these conditions and their family members. The intervention of interest is the Neurobehavioral Non-Pharmacologic Supportive Strategies for Family Caregivers of Persons with Dementia or TBI (NeuroNS-Care). Behavioral symptoms in dementia and following TBI vary considerably over time, with a tendency toward spontaneous regression to the mean. Additionally, caregivers often develop idiosyncratic strategies in response to adverse behaviors that might be either adaptive or maladaptive. In order to separate the effects of time alone from the effects of the coaching intervention, one group will be randomized to delayed intervention following a 6 week wait time. This will allow the investigative team the opportunity to compare the natural history of the outcome variables in an "untrained" portion of the sample to the effects of training over a similar time period.

Conditions

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Dementia Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Caregivers will be randomized in a 1:1 ratio for immediate intervention vs. a 6 week delayed intervention
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Immediate Coaching

Immediately following randomization, online coaching sessions will occur weekly for 6 weeks. Web-based courses containing instructional materials that deal with preventing and reducing care resistant behavior (CRB) within intimate care (dressing, bathing, toileting) and treatment regimens (medication, therapeutic activities) after the initial study visit. The NeuroNS-Care intervention is an innovative distance-learning , internet based, family caregiver coaching program; one for the caregivers of persons with dementia and one for the caregivers of persons recovering from TBI. It will be delivered using Instructure's Canvas™ web-based platform.

Group Type ACTIVE_COMPARATOR

Caregiver Coaching

Intervention Type BEHAVIORAL

Online coaching sessions will occur weekly for 6 weeks. Web-based courses containing instructional materials that deal with preventing and reducing care resistant behavior (CRB) within intimate care (dressing, bathing, toileting) and treatment regimens (medication, therapeutic activities) after the initial study visit. The NeuroNS-Care intervention is an innovative distance-learning , internet based, family caregiver coaching program; one for the caregivers of persons with dementia and one for the caregivers of persons recovering from TBI. It will be delivered using Instructure's Canvas™ web-based platform.

Delayed Coaching

6 weeks following the initial visit, online coaching sessions will occur weekly for 6 weeks. Web-based courses containing instructional materials that deal with preventing and reducing care resistant behavior (CRB) within intimate care (dressing, bathing, toileting) and treatment regimens (medication, therapeutic activities) after the initial study visit. The NeuroNS-Care intervention is an innovative distance-learning , internet based, family caregiver coaching program; one for the caregivers of persons with dementia and one for the caregivers of persons recovering from TBI. It will be delivered using Instructure's Canvas™ web-based platform.

Group Type ACTIVE_COMPARATOR

Caregiver Coaching

Intervention Type BEHAVIORAL

Online coaching sessions will occur weekly for 6 weeks. Web-based courses containing instructional materials that deal with preventing and reducing care resistant behavior (CRB) within intimate care (dressing, bathing, toileting) and treatment regimens (medication, therapeutic activities) after the initial study visit. The NeuroNS-Care intervention is an innovative distance-learning , internet based, family caregiver coaching program; one for the caregivers of persons with dementia and one for the caregivers of persons recovering from TBI. It will be delivered using Instructure's Canvas™ web-based platform.

Interventions

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Caregiver Coaching

Online coaching sessions will occur weekly for 6 weeks. Web-based courses containing instructional materials that deal with preventing and reducing care resistant behavior (CRB) within intimate care (dressing, bathing, toileting) and treatment regimens (medication, therapeutic activities) after the initial study visit. The NeuroNS-Care intervention is an innovative distance-learning , internet based, family caregiver coaching program; one for the caregivers of persons with dementia and one for the caregivers of persons recovering from TBI. It will be delivered using Instructure's Canvas™ web-based platform.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Congressionally Directed Medical Research Programs

FED

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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David Geldmacher

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Geldmacher, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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W81XWH-16-1-0527

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDMRP-AZ150084

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-160819003

Identifier Type: -

Identifier Source: org_study_id