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Completed

NCT Number: NCT04956874

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

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

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AdventHealth, Orlando, Florida, United States

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About this study

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

Hypothesis:

  • 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:

  • CG disease knowledge will increase from pre-assessment to post-assessment.
  • Caregiver preparedness for caregiving will increase from pre-assessment to post-assessment.
  • 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.
  • Caregivers will demonstrate mastery of skill acquisition related to behavior change strategies.
  • Caregiver burden will decrease from pre-assessment to post-assessment.
  • Caregiver self-rated health will improve from pre-assessment to post-assessment.
  • Caregivers will have initiated the process of advanced care planning by the end of the intervention.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Caregiver Burden

    Time frame: Baseline; 6 weeks (therapy termination); 6 month follow-up

    Zarit Burden Inventory

  2. Preparedness for Caregiving Measure

    Time frame: Baseline, session 2, 4, 6 (therapy termination); 6 month follow-up

    Preparedness for dementia caregiving

  3. Alzheimer's disease Knowledge Scale

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

    Knowledge of Alzheimers Disease and Related Dementias

Secondary outcomes

  1. Risk Assessment

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

    FL-REACH Risk assessment

  2. FL-REACH Satisfaction Survey

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

    FL-REACH Satisfaction Survey.

  3. Health Self-Report

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

    Self-Report of personal health

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

  • AdventHealth

Registry information

Official study title

The Florida REACH Translation Project

Acronym: FL-REACH

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 9, 2021
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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