Clinical trial NCT04956874: FL-REACH: Pilot Trial of a Brief Dementia Caregiver Intervention
Official title: The Florida REACH Translation Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Keywords: Caregiving
ADRD
Memory Disorders
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: AdventHealth
First posted: 2021-07-09
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dementia caregivers were recruited initially. When dementia caregiver recruitment was completed, a small control group was recruited.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Caregiver Burden
timeFrame: Baseline; 6 weeks (therapy termination); 6 month follow-up
measure: Preparedness for Caregiving Measure
timeFrame: Baseline, session 2, 4, 6 (therapy termination); 6 month follow-up
measure: Alzheimer's disease Knowledge Scale
timeFrame: Baseline, 6 (therapy termination); 6 month follow-up
Secondary outcomes:
measure: Risk Assessment
timeFrame: Baseline, 6 (therapy termination); 6 month follow-up
measure: FL-REACH Satisfaction Survey
timeFrame: Baseline, 6 (therapy termination); 6 month follow-up
measure: Health Self-Report
timeFrame: Baseline, 6 (therapy termination); 6 month follow-up
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth
state: Florida
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
References: