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

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University of Central Florida

Status

Completed

Conditions

Alzheimer Disease
Dementia

Treatments

Behavioral: FL-REACH

Study type

Interventional

Funder types

Other

Identifiers

NCT04956874
STUDY00000599

Details and patient eligibility

About

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

Full 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.

Enrollment

39 patients

Sex

All

Ages

18 to 89 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

39 participants in 2 patient groups

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

Trial contacts and locations

2

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Central trial contact

Tracy Wharton, PhD; Daniel L Paulson, PhD

Data sourced from clinicaltrials.gov

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