DementiaNCT03734289
Improving Family Quality of Life Through Training to Reduce Care-Resistant Behaviors by People With AD and TBI
A study testing Caregiver Coaching in people with Dementia and Traumatic Brain Injury, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Traumatic Brain Injury
- What is being tested?
- Caregiver Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
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
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.
- Evaluate how the intervention affects the health care costs of people with dementia or TBI.
Read the 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.
- Conditions
- Dementia, Traumatic Brain Injury
- Being tested
- Caregiver Coaching
- Medical subject headings
- Dementia, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Caregiver Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Zarit Burden Interview
A measure of caregiver burden
Measured: Change from baseline to 6-month follow-up
Secondary outcomes (4)
Change in Dementia Quality of Life (DEMQOL/DEMQOL proxy)
Measures of quality of life for the person with dementia
Measured: Change from baseline through 6-month follow-up
Change in Neuropsychiatric Inventory
Measure of behavioral symptomsand caregiver distress
Measured: Change from baseline through 6-month follow-up
Change in Family Quality of Life (Dementia or TBI versions)
Measures of family function and family-based quality of life
Measured: Change from baseline through 6-month follow-up
Change in Connor-Davidson Resilience Scale (CD-RISC)
Measure of caregiver resilience
Measured: Change from baseline through 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Feb 2017
- Primary completion21 Aug 2019
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Caregivers will be randomized in a 1:1 ratio for immediate intervention vs. a 6 week delayed intervention
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, David Geldmacher, University of Alabama at Birmingham
- Investigators
- David Geldmacher, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734289
- Sponsor's protocol ID
- IRB-160819003
- Other IDs
- W81XWH-16-1-0527, CDMRP-AZ150084
- Status last verified
- Dec 2025
- First submitted
- 9 Oct 2018
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03734289
- Acronym / sponsor ID
- IRB-160819003
- Conditions
- Dementia, Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 21 Aug 2019 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Evaluate how the intervention affects the health care costs of people with dementia or TBI.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Caregivers will be randomized in a 1:1 ratio for immediate intervention vs. a 6 week delayed intervention
| Arm | Type | Receives |
|---|---|---|
| Immediate Coaching | Active comparator | Behavioral: Caregiver CoachingImmediately 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. |
| Delayed Coaching | Active comparator | Behavioral: Caregiver Coaching6 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caregiver CoachingOnline 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. | Behavioural | Delayed Coaching, Immediate Coaching |
Primary outcome
Change in Zarit Burden Interview
Time frame: Change from baseline to 6-month follow-up
A measure of caregiver burden
4 secondary outcomes
Change in Dementia Quality of Life (DEMQOL/DEMQOL proxy)
Time frame: Change from baseline through 6-month follow-up
Change in Neuropsychiatric Inventory
Time frame: 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
Change in Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Change from baseline through 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Geldmacher, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver Coaching in people with Dementia and Traumatic Brain Injury, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Zarit Burden Interview (time frame: Change from baseline to 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.