Care-resistant BehaviorCuRB-ITNCT05098652

Coaching Dementia Caregivers to Master Care-Resistant Behavior

A study testing CuRB-IT in people with Care-resistant Behavior and Dementia, run by University of Alabama at Birmingham at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 95 yearsHealthy volunteers can take part
Conditions the study is for: Care-resistant Behavior, Dementia
What is being tested?: CuRB-IT
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 266 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2023to 31 May 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

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 to 95 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1)Caregiver of any race or gender who is aged >18 years
2) provides unpaid care,
3) cares for a spouse/common-law, sibling, parent or grandparent (or in-law, aged 60+ years),
4) lives with or shares cooking facilities with the care recipient,
5) Care recipient has mild cognitive impairment or dementia as identified using the Quick Dementia Rating System instrument,
6) the care provided consists of help with at least 2 Instrumental Activities of Daily Living or one Activity of Daily Living,
7) the care recipient is resistant to receiving assistance with, or refuses to do, at least one instrumental or activity of daily living

Who cannot join

1) persons who cannot speak/read English
2) who do not have reliable access to a smart phone or internet

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham
Birmingham, Alabama, 35244

Other trials in United States

About this study

Official title: Coaching Dementia Caregivers to Master Care-Resistant Behavior and Improve Coping Strategies

266 family caregivers will be randomly assigned to either immediate intervention or delayed intervention groups. All caregivers will complete baseline surveys and 3 weeks of daily diaries. The immediate intervention group will receive 12 weeks of CuRB-IT. They will complete 3 rounds of 3-week daily diaries followed by an intermittent survey at 12 week intervals for the next 33 weeks. The delayed intervention group will receive 12 weeks of attention, complete 1 round of 3-week daily diaries followed by an intermittent survey, then complete 12 weeks of CuRB-IT, and complete 2 rounds of 3--week daily diaries followed by an intermittent survey at 12-week intervals for the next 18 weeks.

Read the detailed description

The purposes of the delayed-intervention randomized clinical trial (N=266) are to:

Care-Resistant Behavior Internet Training (CuRB-IT).

examine the efficacy of CuRB-IT in increasing the self-efficacy of family caregivers of persons living with dementia to handle care-resistant behaviors (CRB);
further test the efficacy of CuRB-IT in improving caregivers coping strategies (a) among the experimental (immediate-intervention group) as compared to the control (delayed-intervention group) (between groups) and (b) within-person from pre- to post- intervention;
examine intervention decay at 3- and 6-months post intervention to determine performance of intervention and inform scheduling of booster sessions;
assess the efficacy of the CuRB-IT intervention in preventing onset of poor coping strategies by family caregivers;
test the hypothesized mechanism of action that increased CRB self-efficacy and use of CuRB-IT problem-focused coping strategies mediate the relationship between CRB stress appraisal and caregiving activities.

Conditions: Care-resistant Behavior, Dementia
Being tested: CuRB-IT
Keywords: dementia, care-resistant behavior, caregiver coping
Medical subject headings: Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CuRB-ITBehavioural
9 1-hour coaching sessions delivered over a videoconferencing platform (Zoom); 6 delivered weekly, 3 delivered biweekly

Study groups in NCT05098652
Study group	Role	What they receive
Immediate Intervention	Experimental	Complete baseline survey, complete 3 weeks of daily diaries and intermittent survey, receive 12 weeks of CurB-IT, then complete 3 rounds of 21-day daily diaries and intermittent surveys while receiving attention during the 12-week intervals between daily diaries. Receives: Behavioral: CuRB-IT
Delayed intervention	Active comparator	Complete baseline survey, complete 3 weeks of daily diaries, receive 12 weeks of attention, complete 3 weeks of daily diaries and 1 intermittent survey, receive 12 weeks of CurB-IT, then complete 2 rounds of 21-day daily diaries and intermittent surveys while receiving attention during the 12-week intervals between daily diaries. Receives: Behavioral: CuRB-IT

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers
Experimental and control
Measured: Daily during weeks 1, 2, and 3
Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers
Experimental and control
Measured: Daily during weeks 15, 16, and 17
Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers
Experimental and control
Measured: Daily during weeks 37, 38, and 39
Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers
Experimental and control
Measured: Daily during weeks 49, 50, and 51
Change in caregiver responses to dementia-related behaviors
Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment).
Measured: Immediately after enrollment
Change in caregiver responses to dementia-related behaviors
Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment).
Measured: Once at week 15
Change in caregiver responses to dementia-related behaviors
Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment).
Measured: Once at week 37
Change in caregiver responses to dementia-related behaviors
Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment).
Measured: Once at week 49
Change in caregiver self-efficacy coping skills
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Measured: Immediately after enrollment
Change in caregiver self-efficacy coping skills
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Measured: Once at week 15
Change in caregiver self-efficacy coping skills
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Measured: Once at week 37
Change in caregiver self-efficacy coping skills
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Measured: Once at week 49
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Experimental (immediate)
Measured: Once at week 15
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Experimental (immediate)
Measured: Once at week 37
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Experimental (immediate)
Measured: Once at week 49
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Control (delayed)
Measured: Once at week 37
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Control (delayed)
Measured: Once at week 49

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202331 May 2027

First posted28 Oct 2021
Study start1 Apr 2023
Primary completion31 Mar 2027 (estimated)
Study completion31 May 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Care-resistant BehaviorStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 266 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05098652
Sponsor's protocol ID: IRB-300007452
Other IDs: R01AG074255
Acronym: CuRB-IT
Status last verified: May 2026
First submitted: 17 Aug 2021
Last updated: 6 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All research data produced by this project will be self-archived at the University of Michigan's NIA-funded National Archive of Computerized Data on Aging. The storage of our research product here will permit many researchers free access to our data in perpetuity. Our archived study will principally include our original (but anonymized) databases as well as any "cleaned," computed, and recoded measures that we produce for or is produced by our analysis. Our project deliverables will include the quantitative databases, a well-documented statistical packaging (SPSS) system file with variable and values labels, a data user guide that includes all SPSS and related computational and analysis syntax code, summary statistics (frequency distributions, means, etc.) for all quantitative variables, a copy of applicable subject consent form, human subject application and the institutional review board (IRB) approval letter, and a blank copy of the survey instrument and interviewer guide.

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Coaching Dementia Caregivers to Master Care-Resistant Behavior and Improve Coping Strategies
ClinicalTrials.gov ID: NCT05098652
Acronym / sponsor ID: CuRB-IT / IRB-300007452
Conditions: Care-resistant Behavior, Dementia
Keywords: dementia, care-resistant behavior, caregiver coping
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 266 participants (estimated)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 1 Apr 2023 (actual)
Primary completion: 31 Mar 2027 (estimated)
Study completion: 31 May 2027 (estimated)
First posted: 28 Oct 2021 (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.

Detailed description

The purposes of the delayed-intervention randomized clinical trial (N=266) are to:

Care-Resistant Behavior Internet Training (CuRB-IT).

examine the efficacy of CuRB-IT in increasing the self-efficacy of family caregivers of persons living with dementia to handle care-resistant behaviors (CRB);
further test the efficacy of CuRB-IT in improving caregivers coping strategies (a) among the experimental (immediate-intervention group) as compared to the control (delayed-intervention group) (between groups) and (b) within-person from pre- to post- intervention;
examine intervention decay at 3- and 6-months post intervention to determine performance of intervention and inform scheduling of booster sessions;
assess the efficacy of the CuRB-IT intervention in preventing onset of poor coping strategies by family caregivers;
test the hypothesized mechanism of action that increased CRB self-efficacy and use of CuRB-IT problem-focused coping strategies mediate the relationship between CRB stress appraisal and caregiving activities.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Immediate Intervention	Experimental	Behavioral: CuRB-ITComplete baseline survey, complete 3 weeks of daily diaries and intermittent survey, receive 12 weeks of CurB-IT, then complete 3 rounds of 21-day daily diaries and intermittent surveys while receiving attention during the 12-week intervals between daily diaries.
Delayed intervention	Active comparator	Behavioral: CuRB-ITComplete baseline survey, complete 3 weeks of daily diaries, receive 12 weeks of attention, complete 3 weeks of daily diaries and 1 intermittent survey, receive 12 weeks of CurB-IT, then complete 2 rounds of 21-day daily diaries and intermittent surveys while receiving attention during the 12-week intervals between daily diaries.

Who may qualify

Ages: 18 to 95 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

1)Caregiver of any race or gender who is aged >18 years
2) provides unpaid care,
3) cares for a spouse/common-law, sibling, parent or grandparent (or in-law, aged 60+ years),
4) lives with or shares cooking facilities with the care recipient,
5) Care recipient has mild cognitive impairment or dementia as identified using the Quick Dementia Rating System instrument,

Key exclusion criteria (2 listed)

1) persons who cannot speak/read English
2) who do not have reliable access to a smart phone or internet

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
CuRB-IT9 1-hour coaching sessions delivered over a videoconferencing platform (Zoom); 6 delivered weekly, 3 delivered biweekly	Behavioural	Delayed intervention, Immediate Intervention

Primary outcome

Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers
Time frame: Daily during weeks 1, 2, and 3
Experimental and control
Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers
Time frame: Daily during weeks 15, 16, and 17
Experimental and control
Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers
Time frame: Daily during weeks 37, 38, and 39
Experimental and control
Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers
Time frame: Daily during weeks 49, 50, and 51
Experimental and control
Change in caregiver responses to dementia-related behaviors
Time frame: Immediately after enrollment
Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment).
Change in caregiver responses to dementia-related behaviors
Time frame: Once at week 15
Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment).
Change in caregiver responses to dementia-related behaviors
Time frame: Once at week 37
Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment).
Change in caregiver responses to dementia-related behaviors
Time frame: Once at week 49
Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment).
Change in caregiver self-efficacy coping skills
Time frame: Immediately after enrollment
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Change in caregiver self-efficacy coping skills
Time frame: Once at week 15
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Change in caregiver self-efficacy coping skills
Time frame: Once at week 37
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Change in caregiver self-efficacy coping skills
Time frame: Once at week 49
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Time frame: Once at week 15
Experimental (immediate)
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Time frame: Once at week 37
Experimental (immediate)
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Time frame: Once at week 49
Experimental (immediate)
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Time frame: Once at week 37
Control (delayed)
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Time frame: Once at week 49
Control (delayed)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
Individual participant dataSharing planned: Yes. All research data produced by this project will be self-archived at the University of Michigan's NIA-funded National Archive of Computerized Data on Aging. The storage of our research product here will permit many researchers free access to our data in perpetuity. Our archived study will principally include our original (but anonymized) databases as well as any "cleaned," computed, and recoded measures that we produce for or is produced by our analysis. Our project deliverables will include the quantitative databases, a well-documented statistical packaging (SPSS) system file with variable and values labels, a data user guide that includes all SPSS and related computational and analysis syntax code, summary statistics (frequency distributions, means, etc.) for all quantitative variables, a copy of applicable subject consent form, human subject application and the institutional review board (IRB) approval letter, and a blank copy of the survey instrument and interviewer guide.

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.

Rita A Jablonski, PhD 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 CuRB-IT in people with Care-resistant Behavior and Dementia, 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 7 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. 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?

This study is still under way. Results are not available in the source record yet.

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 frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers (time frame: Daily during weeks 1, 2, and 3). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05098652.

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 6 May 2026; AzTrials last refreshed its copy on 1 Nov 2026.