FL-REACH: Pilot Trial of a Brief Dementia Caregiver Intervention (FL-REACH)
Primary Purpose
Alzheimer Disease, Dementia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FL-REACH
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Caregiving, ADRD, Memory Disorders
Eligibility Criteria
Inclusion Criteria:
- 1. Age 18-89 2. Identified caregiver or care partner of an individual who has been diagnosed with Alzheimer's disease or another dementia by the memory disorders clinic, and/or who has sought ongoing treatment through the memory disorders clinic 3. Able to provide informed consent 4. Able to engage in the intervention weekly by attending sessions in person at the clinic 5. Able to participate in the intervention in English or in Spanish 6. No previous experience with a caregiver training program in the past (this applies to theory based, structured interventions delivered by professionals, and does not include peer-led support groups that the family may have engaged with)
Exclusion Criteria:
- 1. Under age of 18 or over the age of 89 2. Unable to provide informed consent or subject to a conflict of interest for this study 3. Unable to return regularly to the clinic for sessions 4. Engaged in another caregiver training program concurrently or have completed a multi-week caregiver training program in the past (this exclusion applies to theory based, structured interventions delivered by professionals, and does not include peer-led support groups that the family may have engaged with)
Sites / Locations
- AdventHealthRecruiting
- University of Central FloridaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Control Group
Arm Description
Participants will complete the FL-REACH annualized caregiver intervention.
No-intervention control group
Outcomes
Primary Outcome Measures
Caregiver Burden
Zarit Burden Inventory
Preparedness for Caregiving Measure
Preparedness for dementia caregiving
Alzheimer's disease Knowledge Scale
Knowledge of Alzheimers Disease and Related Dementias
Secondary Outcome Measures
Risk Assessment
FL-REACH Risk assessment
FL-REACH Satisfaction Survey
FL-REACH Satisfaction Survey.
Health Self-Report
Self-Report of personal health
Full Information
NCT ID
NCT04956874
First Posted
June 22, 2021
Last Updated
June 30, 2021
Sponsor
University of Central Florida
Collaborators
AdventHealth
1. Study Identification
Unique Protocol Identification Number
NCT04956874
Brief Title
FL-REACH: Pilot Trial of a Brief Dementia Caregiver Intervention
Acronym
FL-REACH
Official Title
The Florida REACH Translation Project
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
October 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Central Florida
Collaborators
AdventHealth
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary aim of this study is to test feasibility of a modified REACH II intervention in an outpatient clinic.
Detailed Description
Primary Aim The primary aim of this study is to test feasibility of a modified REACH II intervention in an outpatient clinic.
Hypothesis:
The FL REACH intervention can be implemented reliably in this setting, with fidelity to the model and minimal burden on existing clinic structure.
Secondary Aims Aim 2: Examine the effectiveness of a REACH II translation in an outpatient setting.
Hypotheses:
CG disease knowledge will increase from pre-assessment to post-assessment.
Caregiver preparedness for caregiving will increase from pre-assessment to post-assessment.
Perceived risk by CG (CR access to dangerous objects + smoking + supervision + wandering + driving + screaming + desire to hit) will be reduced from pre-assessment to post-assessment.
Caregivers will demonstrate mastery of skill acquisition related to behavior change strategies.
Caregiver burden will decrease from pre-assessment to post-assessment.
Caregiver self-rated health will improve from pre-assessment to post-assessment.
Caregivers will have initiated the process of advanced care planning by the end of the intervention.
All measures will maintain gain in the anticipated direction from baseline measures at 6 months post-assessment.
Aim 3: Identify possible moderators of outcome, such as race/ethnicity, language, dosage or relationship.
This Aim is exploratory. Based in previous evidence, we estimate similar outcomes for all participants regardless of demographic factors, but previous trials have never been attempted in this novel setting. We will examine the data for differential outcomes related to such factors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia
Keywords
Caregiving, ADRD, Memory Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Dementia caregivers were recruited initially. When dementia caregiver recruitment was completed, a small control group was recruited.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Participants will complete the FL-REACH annualized caregiver intervention.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No-intervention control group
Intervention Type
Behavioral
Intervention Name(s)
FL-REACH
Intervention Description
The FL REACH intervention is a 6-session intervention designed to facilitate transition to care following delivery of a memory disorders diagnosis by a MDC team. The intervention focused on an approach that used a toolbox of strategies to tailor skills-based learning, knowledge transmission, and self-care strategies to dementia caregivers. This pilot study focuses on adapting the established REACH II intervention for translation to the clinical setting, with a focus not only on implementation of the key components of the program, but also on feasibility and sustainability. This is part of a stepped-care model that is being developed at the AdventHealth-Orlando MDC. Caregivers of patients will be referred to the FL REACH intervention for foundational training and skills-development.
Primary Outcome Measure Information:
Title
Caregiver Burden
Description
Zarit Burden Inventory
Time Frame
Baseline; 6 weeks (therapy termination); 6 month follow-up
Title
Preparedness for Caregiving Measure
Description
Preparedness for dementia caregiving
Time Frame
Baseline, session 2, 4, 6 (therapy termination); 6 month follow-up
Title
Alzheimer's disease Knowledge Scale
Description
Knowledge of Alzheimers Disease and Related Dementias
Time Frame
Baseline, 6 (therapy termination); 6 month follow-up
Secondary Outcome Measure Information:
Title
Risk Assessment
Description
FL-REACH Risk assessment
Time Frame
Baseline, 6 (therapy termination); 6 month follow-up
Title
FL-REACH Satisfaction Survey
Description
FL-REACH Satisfaction Survey.
Time Frame
Baseline, 6 (therapy termination); 6 month follow-up
Title
Health Self-Report
Description
Self-Report of personal health
Time Frame
Baseline, 6 (therapy termination); 6 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. Age 18-89 2. Identified caregiver or care partner of an individual who has been diagnosed with Alzheimer's disease or another dementia by the memory disorders clinic, and/or who has sought ongoing treatment through the memory disorders clinic 3. Able to provide informed consent 4. Able to engage in the intervention weekly by attending sessions in person at the clinic 5. Able to participate in the intervention in English or in Spanish 6. No previous experience with a caregiver training program in the past (this applies to theory based, structured interventions delivered by professionals, and does not include peer-led support groups that the family may have engaged with)
Exclusion Criteria:
1. Under age of 18 or over the age of 89 2. Unable to provide informed consent or subject to a conflict of interest for this study 3. Unable to return regularly to the clinic for sessions 4. Engaged in another caregiver training program concurrently or have completed a multi-week caregiver training program in the past (this exclusion applies to theory based, structured interventions delivered by professionals, and does not include peer-led support groups that the family may have engaged with)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel L Paulson, PhD
Phone
407-823-3578
Email
paulson@ucf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tracy Wharton, PhD
Phone
tel:407-823-2819
Email
Tracy.Wharton@ucf.edu
Facility Information:
Facility Name
AdventHealth
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gail Shepherd, RN
Email
mailto:Gayle.Shepherd@AdventHealth.com
Facility Name
University of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel L Paulson, PhD
Phone
407-823-3578
Email
Paulson@ucf.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD at this time.
Learn more about this trial
FL-REACH: Pilot Trial of a Brief Dementia Caregiver Intervention
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