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

Not Applicable

Completed

• Conditions: Alzheimer Disease; Dementia
• Interventions: Behavioral: FL-REACH

• Registration Number: NCT04956874
• Lead Sponsor: University of Central Florida

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:

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 Timeline

• Study Start: 2019-10-04
• Primary Completion: 2020-09-17
• Study Completion: 2020-09-17
• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	FL-REACH	Participants will complete the FL-REACH annualized caregiver intervention.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (2)

AdventHealth; 🇺🇸 Orlando, Florida, United States

University of Central Florida; 🇺🇸 Orlando, Florida, United States