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

NCT04956874 | Completed

• 1 other identifier: STUDY00000599
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Alzheimer Disease; Dementia

Keywords

Caregiving; ADRD; Memory Disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Risk Assessment

  Baseline, 6 (therapy termination); 6 month follow-up

• FL-REACH Satisfaction Survey

  Baseline, 6 (therapy termination); 6 month follow-up

• Health Self-Report

  Baseline, 6 (therapy termination); 6 month follow-up

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants will complete the FL-REACH annualized caregiver intervention.

Behavioral: FL-REACH

Control Group

NO INTERVENTION

No-intervention control group

Interventions

FL-REACH BEHAVIORAL

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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)

Sponsors & Collaborators

• University of Central Florida: lead
• AdventHealth: collaborator

Study Sites (2)

AdventHealth

Orlando, Florida, 32803, United States

Location

University of Central Florida

Orlando, Florida, 32816, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Memory Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 9, 2021
• Study Start: October 4, 2019
• Primary Completion: September 17, 2020
• Study Completion: September 17, 2020
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)