Clinical trial NCT03333252: A Non-pharmacological Intervention for Patients With Alzheimer's Disease and Family Caregivers (Care Partners Program)
Official title: Dual Target Program: An Non-pharmacological Intervention for Family Caregivers and Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver
Keywords: Caregiver
Psycho-social intervention
Cognitive training
Quality of life
Early on-set Alzheimer's Disease
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-11-06
Enrollment: 352
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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 processing speed and quality of life, and caregiver outcomes such as; depression, burden, self-care activities and social support . Information will also be gathered on ethnic differences in response to the intervention and estimates of cost effectiveness of the intervention.

Detailed description: 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 level of burden, and depression perceived by the CG while providing the care, the amount of social support available to the CG, and the self-care activities of the CG to provide continuing care to their loved ones. The assessment with the care recipient consists of measures of processing speed (digit symbol). In addition, the care recipient will complete a computer-based questionnaire assessing their quality of life. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Depression Score for Caregiver as Measured by CES-D
timeFrame: Baseline, 6-mth follow-up and 12-mth follow-up
Secondary outcomes:
measure: Change in Caregiving Burden Score for Caregiver as Measured by Burden Inventory
timeFrame: Baseline, 6-mth follow-up and 12-mth follow-up
Other outcomes:
measure: Change in Caregiver's Self Report of Self-care
timeFrame: Baseline, 6-mth follow-up and 12-mth follow-up
measure: Change in Caregiver's Social Support
timeFrame: Baseline, 6-mth follow-up and 12-mth follow-up
measure: Change in Care Recipient's Qualify of Life
timeFrame: Baseline, 6-mth follow-up, and 12-mth follow-up
measure: Change in Care Recipient's Processing Speed Using Digit Symbol Test
timeFrame: Baseline, 6-mth follow-up, and 12-mth follow-up
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Sara J. Czaja, PhD
role: PRINCIPAL_INVESTIGATOR
References: