- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03734289
Improving Family Quality of Life Through Training to Reduce Care-Resistant Behaviors by People With AD and TBI
Improving Family Quality of Life Through Training to Reduce Care-Resistant Behaviors by People With Alzheimer Dementia and Traumatic Brain Injury (NeuroNS) Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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.
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Zarit Burden Interview
Time Frame: Change from baseline to 6-month follow-up
|
A measure of caregiver burden
|
Change from baseline to 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Dementia Quality of Life (DEMQOL/DEMQOL proxy)
Time Frame: Change from baseline through 6-month follow-up
|
Measures of quality of life for the person with dementia
|
Change from baseline through 6-month follow-up
|
Change in Neuropsychiatric Inventory
Time Frame: Change from baseline through 6-month follow-up
|
Measure of behavioral symptomsand caregiver distress
|
Change from baseline through 6-month follow-up
|
Change in Family Quality of Life (Dementia or TBI versions)
Time Frame: Change from baseline through 6-month follow-up
|
Measures of family function and family-based quality of life
|
Change from baseline through 6-month follow-up
|
Change in Connor-Davidson Resilience Scale (CD-RISC)
Time Frame: Change from baseline through 6-month follow-up
|
Measure of caregiver resilience
|
Change from baseline through 6-month follow-up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David Geldmacher, MD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-160819003
- W81XWH-16-1-0527 (Other Grant/Funding Number: US Dept of Defense)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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