A Non-pharmacological Intervention for Patients With Alzheimer's Disease and Family Caregivers (Care Partners Program)
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 3/28/2019 |
| Start Date: | January 29, 2018 |
| End Date: | April 30, 2021 |
| Contact: | Chelsie Burchett, MA |
| Email: | cob2014@med.cornell.edu |
| Phone: | 646-962-7140 |
Dual Target Program: An Non-pharmacological Intervention for Family Caregivers and Patients With Alzheimer's Disease
The proposed study will develop and test the efficacy and feasibility of a dyadic-based
intervention program (DT), delivered through state-of-the art computer tablet technology. A
novel feature of the investigation is its focus on both the caregiver and the recipient of
care (person with AD) and the integration of an evidenced-based caregiver intervention and
evidenced-based cognitive/functional training for the care recipient. The program will be
tailored for the caregiver and emphasize issues important to caregivers, not only in the
earlier stages of caregiving, but will also target issues across the caregiving trajectory to
help prepare the caregiver for changes in their role. Two hundred and forty Hispanic, African
American and White/Caucasian dyads will be randomized to the DT intervention or Control
condition. Measures at baseline and the 6 and 12-month follow-ups will include indices of
care recipient cognitive and functional status, and caregiver outcomes such as; quality of
life, distress, and caregiving efficacy. Information will also be gathered on ethnic
differences in response to the intervention and estimates of cost effectiveness of the
intervention.
intervention program (DT), delivered through state-of-the art computer tablet technology. A
novel feature of the investigation is its focus on both the caregiver and the recipient of
care (person with AD) and the integration of an evidenced-based caregiver intervention and
evidenced-based cognitive/functional training for the care recipient. The program will be
tailored for the caregiver and emphasize issues important to caregivers, not only in the
earlier stages of caregiving, but will also target issues across the caregiving trajectory to
help prepare the caregiver for changes in their role. Two hundred and forty Hispanic, African
American and White/Caucasian dyads will be randomized to the DT intervention or Control
condition. Measures at baseline and the 6 and 12-month follow-ups will include indices of
care recipient cognitive and functional status, and caregiver outcomes such as; quality of
life, distress, and caregiving efficacy. Information will also be gathered on ethnic
differences in response to the intervention and estimates of cost effectiveness of the
intervention.
We will recruit and randomly assign, following a baseline assessment, 246 dyads will be
enrolled and randomly assigned to one of two groups: 1) Caregiving Condition or 2) Health
Promotion (Nutrition) Condition. The entire study is home-based. The intervention will be
delivered over 6 months using computer tablet technology in Spanish or English. Assessments
will occur in the beginning of the study, 6 months, and 12 months (after completion of the
intervention)
Interested participants (caregivers) can contact us via telephone or email after seeing a
flyer posted in various WCM/NYP locations including the Irving Sherwood Wright Center on
Aging. One of our research associates (RA) will provide more information about the study to
potential participants. The trained RA will use a telephone script with consent language to
obtain permission to ask them questions to determine their eligibility through a phone screen
script. If the participant is ineligible for the study, all screening data will be deleted.
If the caregiver participant is eligible for the study, an appointment will be provided, and
one of our RAs will visit the participants (caregiver and care recipient) and conduct the
baseline assessment at the participants' home in their preferred language (Spanish or
English). This assessment with the caregiver will last between 2 and 3 hours, additionally
the assessment with the care recipient will last approximately 1.5 hours. We will use
Qualtrics (online survey/data collection service) to administer the assessments.
The baseline assessment with the caregiver (CG) consists of a series of questionnaires
assessing the help provided by the CG to the care recipient (e.g., ADLs/AIDLs), the level of
burden, stress, and depression perceived by the CG while providing the care, the amount of
social support available to the CG, and the preparedness of the CG to provide continuing care
to their loved ones. The assessment with the care recipient consists of measures of
depression, executive functioning (Trails A & B), working memory (Letters and Number set),
processing speed (digit symbol), and verbal fluency (category fluency). In addition, the care
recipient will complete a computer-based suite of tasks (e.g., ATM, prescription refill,
forms filling, etc) assessing their functional status. The assessment with the caregiver and
care recipient might not be completed in the same home visit. The study protocol allows
multiple visits to complete the assessments.
During the baseline home visit, the RA will go over the written informed consent and HIPAA
authorization with the participants (caregiver and care recipient). The assessment will not
begin unless the participant has a full understanding of the informed consent form and has
signed the form. The care recipient will additionally be given a Consent Feedback Tool, as an
added step to make sure they understand the consent form since they have mild cognitive
impairment.
enrolled and randomly assigned to one of two groups: 1) Caregiving Condition or 2) Health
Promotion (Nutrition) Condition. The entire study is home-based. The intervention will be
delivered over 6 months using computer tablet technology in Spanish or English. Assessments
will occur in the beginning of the study, 6 months, and 12 months (after completion of the
intervention)
Interested participants (caregivers) can contact us via telephone or email after seeing a
flyer posted in various WCM/NYP locations including the Irving Sherwood Wright Center on
Aging. One of our research associates (RA) will provide more information about the study to
potential participants. The trained RA will use a telephone script with consent language to
obtain permission to ask them questions to determine their eligibility through a phone screen
script. If the participant is ineligible for the study, all screening data will be deleted.
If the caregiver participant is eligible for the study, an appointment will be provided, and
one of our RAs will visit the participants (caregiver and care recipient) and conduct the
baseline assessment at the participants' home in their preferred language (Spanish or
English). This assessment with the caregiver will last between 2 and 3 hours, additionally
the assessment with the care recipient will last approximately 1.5 hours. We will use
Qualtrics (online survey/data collection service) to administer the assessments.
The baseline assessment with the caregiver (CG) consists of a series of questionnaires
assessing the help provided by the CG to the care recipient (e.g., ADLs/AIDLs), the level of
burden, stress, and depression perceived by the CG while providing the care, the amount of
social support available to the CG, and the preparedness of the CG to provide continuing care
to their loved ones. The assessment with the care recipient consists of measures of
depression, executive functioning (Trails A & B), working memory (Letters and Number set),
processing speed (digit symbol), and verbal fluency (category fluency). In addition, the care
recipient will complete a computer-based suite of tasks (e.g., ATM, prescription refill,
forms filling, etc) assessing their functional status. The assessment with the caregiver and
care recipient might not be completed in the same home visit. The study protocol allows
multiple visits to complete the assessments.
During the baseline home visit, the RA will go over the written informed consent and HIPAA
authorization with the participants (caregiver and care recipient). The assessment will not
begin unless the participant has a full understanding of the informed consent form and has
signed the form. The care recipient will additionally be given a Consent Feedback Tool, as an
added step to make sure they understand the consent form since they have mild cognitive
impairment.
CAREGIVER (CG)
Inclusion Criteria:
- MMSE ≥ 26 (with Mungus age and education correction)
- Providing care for a friend or relative with AD for a minimum of eight hours per week
for at least the past six months
- Being over the age of 21 years
- Living with or nearby the patient
- Having a telephone
- Planning to stay in the study geographic area for the duration of the study
Exclusion Criteria:
- Not providing care to someone with memory problems
- Paid caregivers
- Has terminal illness with life expectancy of 6 months or less
CARE RECIPIENT (CR)
Inclusion Criteria:
- MMSE 18 - 25 (with Mungus age and education correction) (if scores high on MMSE, the
care recipient has to score 1.0 in the Clinical Dementia Rating Scale (CDR))
- Needs help with higher level of IADL (e.g., managing finances, helping remember
appointments, handling medications)
- Show memory problems
Exclusion Criteria:
- Lives in nursing home or facility
- Going to be placed in a facility in the next 6 months
- Has terminal illness with life expectancy of 6 months or less
We found this trial at
2
sites
1601 Northwest 12th Avenue
Miami, Florida 33136
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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