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Clinical Trial Summary

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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04956874
Study type Interventional
Source University of Central Florida
Contact
Status Completed
Phase N/A
Start date October 4, 2019
Completion date September 17, 2020

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