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Coaching Dementia Caregivers to Master Care-Resistant Behavior (CuRB-IT)

Primary Purpose

Care-resistant Behavior, Dementia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CuRB-IT
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Care-resistant Behavior focused on measuring dementia, care-resistant behavior, caregiver coping

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1)Caregiver of any race or gender who is aged >18 years
  • 2) provides unpaid care,
  • 3) cares for a spouse/common-law, 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

Exclusion Criteria:

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate Intervention

Delayed intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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
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).
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).
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).
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).
Change in caregiver self-efficacy coping skills
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Change in caregiver self-efficacy coping skills
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Change in caregiver self-efficacy coping skills
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Change in caregiver self-efficacy coping skills
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
Experimental (immediate)
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Experimental (immediate)
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Experimental (immediate)
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Control (delayed)
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Control (delayed)

Secondary Outcome Measures

Full Information

First Posted
August 17, 2021
Last Updated
April 17, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05098652
Brief Title
Coaching Dementia Caregivers to Master Care-Resistant Behavior
Acronym
CuRB-IT
Official Title
Coaching Dementia Caregivers to Master Care-Resistant Behavior and Improve Coping Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
September 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Care-resistant Behavior, Dementia
Keywords
dementia, care-resistant behavior, caregiver coping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
266 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CuRB-IT
Intervention Description
9 1-hour coaching sessions delivered over a videoconferencing platform (Zoom); 6 delivered weekly, 3 delivered biweekly
Primary Outcome Measure Information:
Title
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
Description
Experimental and control
Time Frame
Daily during weeks 1, 2, and 3
Title
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
Description
Experimental and control
Time Frame
Daily during weeks 15, 16, and 17
Title
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
Description
Experimental and control
Time Frame
Daily during weeks 37, 38, and 39
Title
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
Description
Experimental and control
Time Frame
Daily during weeks 49, 50, and 51
Title
Change in caregiver responses to dementia-related behaviors
Description
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).
Time Frame
Immediately after enrollment
Title
Change in caregiver responses to dementia-related behaviors
Description
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).
Time Frame
Once at week 15
Title
Change in caregiver responses to dementia-related behaviors
Description
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).
Time Frame
Once at week 37
Title
Change in caregiver responses to dementia-related behaviors
Description
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).
Time Frame
Once at week 49
Title
Change in caregiver self-efficacy coping skills
Description
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Time Frame
Immediately after enrollment
Title
Change in caregiver self-efficacy coping skills
Description
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Time Frame
Once at week 15
Title
Change in caregiver self-efficacy coping skills
Description
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Time Frame
Once at week 37
Title
Change in caregiver self-efficacy coping skills
Description
Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.
Time Frame
Once at week 49
Title
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Description
Experimental (immediate)
Time Frame
Once at week 15
Title
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Description
Experimental (immediate)
Time Frame
Once at week 37
Title
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Description
Experimental (immediate)
Time Frame
Once at week 49
Title
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Description
Control (delayed)
Time Frame
Once at week 37
Title
Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist
Description
Control (delayed)
Time Frame
Once at week 49

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1)Caregiver of any race or gender who is aged >18 years 2) provides unpaid care, 3) cares for a spouse/common-law, 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 Exclusion Criteria: 1) persons who cannot speak/read English 2) who do not have reliable access to a smart phone or internet
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rita A Jablonski, PhD
Phone
205-975-9019
Email
rajablon@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Puga, PhD
Phone
205-975-9423
Email
fpuga@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita A Jablonski, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita A Jablonski, PhD
Phone
205-975-9019
Email
rajablon@uab.edu
First Name & Middle Initial & Last Name & Degree
Frank Puga, PhD
Phone
205-9759423
Email
fpuga@uab.edu
First Name & Middle Initial & Last Name & Degree
Frank Puga, PhD
First Name & Middle Initial & Last Name & Degree
Liang Shan, PhD
First Name & Middle Initial & Last Name & Degree
Laura Mosqueda, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
6 months after conclusion of study; in perpetuity
IPD Sharing Access Criteria
1) a commitment only to use the data for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroy or return the data after analyses are completed.

Learn more about this trial

Coaching Dementia Caregivers to Master Care-Resistant Behavior

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