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

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ClinicalTrials.gov Identifier: NCT03734289
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
David Geldmacher, University of Alabama at Birmingham

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.


Condition or disease Intervention/treatment Phase
Dementia Traumatic Brain Injury Behavioral: Caregiver Coaching Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Caregivers will be randomized in a 1:1 ratio for immediate intervention vs. a 6 week delayed intervention
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Family Quality of Life Through Training to Reduce Care-Resistant Behaviors by People With Alzheimer Dementia and Traumatic Brain Injury (NeuroNS) Study
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

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.
Behavioral: 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.

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.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in Zarit Burden Interview [ Time Frame: Change from baseline to 6-month follow-up ]
    A measure of caregiver burden


Secondary Outcome Measures :
  1. 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

  2. Change in Neuropsychiatric Inventory [ Time Frame: Change from baseline through 6-month follow-up ]
    Measure of behavioral symptomsand caregiver distress

  3. 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

  4. Change in Connor-Davidson Resilience Scale (CD-RISC) [ Time Frame: Change from baseline through 6-month follow-up ]
    Measure of caregiver resilience



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734289


Contacts
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Contact: Vicki Winstead, PhD 205-934-9260 vickiwin@uab.edu
Contact: Giovanna Pilonieta, DDS, MPH 205-934-1821 gpilonieta@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Vicki Winstead, Phd    205-934-9260    vickiwin@uab.edu   
Contact: Giovnna Pilonieta, DDS, MPH    205-934-1821    gpilonieta@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: David Geldmacher, MD University of Alabama at Birmingham

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Responsible Party: David Geldmacher, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03734289     History of Changes
Other Study ID Numbers: IRB-160819003
W81XWH-16-1-0527 ( Other Grant/Funding Number: US Dept of Defense )
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Craniocerebral Trauma
Trauma, Nervous System