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

NCT03734289 | Completed

• 3 other identifiers: IRB-160819003W81XWH-16-1-0527CDMRP-AZ150084
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Change in Zarit Burden Interview

  A measure of caregiver burden

  Change from baseline to 6-month follow-up

Secondary Outcomes (4)

• Change in Dementia Quality of Life (DEMQOL/DEMQOL proxy)

  Change from baseline through 6-month follow-up

• Change in Neuropsychiatric Inventory

  Change from baseline through 6-month follow-up

• Change in Family Quality of Life (Dementia or TBI versions)

  Change from baseline through 6-month follow-up

• Change in Connor-Davidson Resilience Scale (CD-RISC)

  Change from baseline through 6-month follow-up

Study Arms (2)

Immediate Coaching

ACTIVE COMPARATOR

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.

Behavioral: Caregiver Coaching

Delayed Coaching

ACTIVE COMPARATOR

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.

Behavioral: Caregiver Coaching

Interventions

Caregiver Coaching 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; Immediate Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• United States Department of Defense: collaborator
• Congressionally Directed Medical Research Programs: collaborator
• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Dementia; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• David Geldmacher, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Caregivers will be randomized in a 1:1 ratio for immediate intervention vs. a 6 week delayed intervention

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: November 7, 2018
• Study Start: February 1, 2017
• Primary Completion: August 21, 2019
• Study Completion: August 31, 2021
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (1)