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

The Florida REACH Translation Project

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

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease
• Intervention / Treatment: Behavioral: FL-REACH

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:

1. 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:

2. CG disease knowledge will increase from pre-assessment to post-assessment.
3. Caregiver preparedness for caregiving will increase from pre-assessment to post-assessment.
4. 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.
5. Caregivers will demonstrate mastery of skill acquisition related to behavior change strategies.
6. Caregiver burden will decrease from pre-assessment to post-assessment.
7. Caregiver self-rated health will improve from pre-assessment to post-assessment.
8. Caregivers will have initiated the process of advanced care planning by the end of the intervention.
9. 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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32816
      • University of Central Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk Assessment	FL-REACH Risk assessment	Baseline, 6 (therapy termination); 6 month follow-up
FL-REACH Satisfaction Survey	FL-REACH Satisfaction Survey.	Baseline, 6 (therapy termination); 6 month follow-up
Health Self-Report	Self-Report of personal health	Baseline, 6 (therapy termination); 6 month follow-up

Collaborators and Investigators

• Sponsor: University of Central Florida
• Collaborators: AdventHealth

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2019
• Primary Completion (Actual): September 17, 2020
• Study Completion (Actual): September 17, 2020

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Caregiving; Memory Disorders; ADRD
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: STUDY00000599

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No