Alzheimer DiseaseFL-REACHNCT04956874
FL-REACH: Pilot Trial of a Brief Dementia Caregiver Intervention
A study testing FL-REACH in people with Alzheimer Disease and Dementia, run by University of Central Florida at 2 sites in United States.
Trial summary
The primary aim of this study is to test feasibility of a modified REACH II intervention in an outpatient clinic. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia
- What is being tested?
- FL-REACH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Oct 2019to 17 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
AdventHealth
Orlando, Florida, 32803
University of Central Florida
Orlando, Florida, 32816
About this study
Official title: The Florida REACH Translation Project
The primary aim of this study is to test feasibility of a modified REACH II intervention in an outpatient clinic.
Read the 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:
- 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.
- Conditions
- Alzheimer Disease, Dementia
- Being tested
- FL-REACH
- Keywords
- Caregiving, ADRD, Memory Disorders
- Medical subject headings
- Alzheimer Disease, Dementia, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FL-REACHBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants will complete the FL-REACH annualized caregiver intervention. Receives: Behavioral: FL-REACH |
| Control Group | No intervention | No-intervention control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Burden
Zarit Burden Inventory
Measured: Baseline; 6 weeks (therapy termination); 6 month follow-up
Preparedness for Caregiving Measure
Preparedness for dementia caregiving
Measured: Baseline, session 2, 4, 6 (therapy termination); 6 month follow-up
Alzheimer's disease Knowledge Scale
Knowledge of Alzheimers Disease and Related Dementias
Measured: Baseline, 6 (therapy termination); 6 month follow-up
Secondary outcomes (3)
Risk Assessment
FL-REACH Risk assessment
Measured: Baseline, 6 (therapy termination); 6 month follow-up
FL-REACH Satisfaction Survey
FL-REACH Satisfaction Survey.
Measured: Baseline, 6 (therapy termination); 6 month follow-up
Health Self-Report
Self-Report of personal health
Measured: Baseline, 6 (therapy termination); 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start4 Oct 2019
- Primary completion17 Sep 2020
- Study completion17 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Dementia caregivers were recruited initially. When dementia caregiver recruitment was completed, a small control group was recruited.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- AdventHealth
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956874
- Sponsor's protocol ID
- STUDY00000599
- Acronym
- FL-REACH
- Status last verified
- Apr 2024
- First submitted
- 22 Jun 2021
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD at this time.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Florida REACH Translation Project
- ClinicalTrials.gov ID
- NCT04956874
- Acronym / sponsor ID
- FL-REACH / STUDY00000599
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- Caregiving, ADRD, Memory Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- AdventHealth
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 17 Sep 2020 (actual)
- Study completion
- 17 Sep 2020 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dementia caregivers were recruited initially. When dementia caregiver recruitment was completed, a small control group was recruited.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: FL-REACHParticipants will complete the FL-REACH annualized caregiver intervention. |
| Control Group | No intervention | –No-intervention control group |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FL-REACHThe 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. | Behavioural | Experimental Group |
Primary outcome
Caregiver Burden
Time frame: Baseline; 6 weeks (therapy termination); 6 month follow-up
Zarit Burden Inventory
Preparedness for Caregiving Measure
Time frame: Baseline, session 2, 4, 6 (therapy termination); 6 month follow-up
Preparedness for dementia caregiving
Alzheimer's disease Knowledge Scale
Time frame: Baseline, 6 (therapy termination); 6 month follow-up
Knowledge of Alzheimers Disease and Related Dementias
3 secondary outcomes
Risk Assessment
Time frame: Baseline, 6 (therapy termination); 6 month follow-up
FL-REACH Satisfaction Survey
Time frame: Baseline, 6 (therapy termination); 6 month follow-up
Health Self-Report
Time frame: Baseline, 6 (therapy termination); 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No. There is no plan to share IPD at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FL-REACH in people with Alzheimer Disease and Dementia, run by University of Central Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Burden (time frame: Baseline; 6 weeks (therapy termination); 6 month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.