FL-REACH: Pilot Trial of a Brief Dementia Caregiver Intervention

Sponsor

University of Central Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT04956874

Collaborator

AdventHealth (Other)

Enrollment

Locations

Arms

24.4

Anticipated Duration (Months)

18.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary aim of this study is to test feasibility of a modified REACH II intervention in an outpatient clinic.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease Dementia	Behavioral: FL-REACH	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

37 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Dementia caregivers were recruited initially. When dementia caregiver recruitment was completed, a small control group was recruited.Dementia caregivers were recruited initially. When dementia caregiver recruitment was completed, a small control group was recruited.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Florida REACH Translation Project

Actual Study Start Date :

Oct 4, 2019

Anticipated Primary Completion Date :

Aug 30, 2021

Anticipated Study Completion Date :

Oct 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group Participants will complete the FL-REACH annualized caregiver intervention.	Behavioral: FL-REACH 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.
No Intervention: Control Group No-intervention control group

Arm

Intervention/Treatment

Experimental: Experimental Group

Participants will complete the FL-REACH annualized caregiver intervention.

Behavioral: FL-REACH

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.

No Intervention: Control Group

No-intervention control group

Outcome Measures

Primary Outcome Measures

Caregiver Burden [Baseline; 6 weeks (therapy termination); 6 month follow-up]
Zarit Burden Inventory
Preparedness for Caregiving Measure [Baseline, session 2, 4, 6 (therapy termination); 6 month follow-up]
Preparedness for dementia caregiving
Alzheimer's disease Knowledge Scale [Baseline, 6 (therapy termination); 6 month follow-up]
Knowledge of Alzheimers Disease and Related Dementias

Secondary Outcome Measures

Risk Assessment [Baseline, 6 (therapy termination); 6 month follow-up]
FL-REACH Risk assessment
FL-REACH Satisfaction Survey [Baseline, 6 (therapy termination); 6 month follow-up]
FL-REACH Satisfaction Survey.
Health Self-Report [Baseline, 6 (therapy termination); 6 month follow-up]
Self-Report of personal health

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AdventHealth	Orlando	Florida	United States	32803
2	University of Central Florida	Orlando	Florida	United States	32816

Sponsors and Collaborators

University of Central Florida
AdventHealth

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Central Florida

ClinicalTrials.gov Identifier:

NCT04956874

Other Study ID Numbers:

STUDY00000599

First Posted:

Jul 9, 2021

Last Update Posted:

Jul 9, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Central Florida

Caregiving

ADRD

Memory Disorders

Additional relevant MeSH terms:

Alzheimer Disease

Dementia

Study Results

No Results Posted as of Jul 9, 2021