- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03333252
A Non-pharmacological Intervention for Patients With Alzheimer's Disease and Family Caregivers (Care Partners Program) (CPProgram)
Dual Target Program: An Non-pharmacological Intervention for Family Caregivers and Patients With Alzheimer's Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami Miller School of Medicine
-
-
New York
-
New York, New York, United States, 10065
- Weill Cornell Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Condition
Exposing caregivers to caregiving-related information and care recipients to cognitive training tasks
|
Caregivers will access caregiving related information.
Care Recipients will access cognitive training program
|
Placebo Comparator: Control Condition
Exposing caregivers to Nutrition and Health promotional material.
The care recipients are exposed to plain words games from computer.
|
Caregivers will access Nutrition and Health Promotion material.
Care Recipients will access words and card games
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depression Score for Caregiver as Measured by CES-D
Time Frame: Baseline, 6-mth follow-up and 12-mth follow-up
|
Higher score on the Center for Epidemiological Studies Depression scale (CES-D) means greater frequency of depressive symptoms.
Range (0-30)
|
Baseline, 6-mth follow-up and 12-mth follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Caregiving Burden Score for Caregiver as Measured by Burden Inventory
Time Frame: Baseline, 6-mth follow-up and 12-mth follow-up
|
Higher score means greater level of caregiver burden.
Range (0-44)
|
Baseline, 6-mth follow-up and 12-mth follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Caregiver's Self Report of Self-care
Time Frame: Baseline, 6-mth follow-up and 12-mth follow-up
|
Higher score means better in keeping medical obligations to him/herself.
Range (0-12)
|
Baseline, 6-mth follow-up and 12-mth follow-up
|
Change in Caregiver's Social Support
Time Frame: Baseline, 6-mth follow-up and 12-mth follow-up
|
Higher score means more social support for the caregiver.
Range (0-40)
|
Baseline, 6-mth follow-up and 12-mth follow-up
|
Change in Care Recipient's Qualify of Life
Time Frame: Baseline, 6-mth follow-up, and 12-mth follow-up
|
Higher score means better quality of life as Alzheimer's patient.
Range (0-52)
|
Baseline, 6-mth follow-up, and 12-mth follow-up
|
Change in Care Recipient's Processing Speed Using Digit Symbol Test
Time Frame: Baseline, 6-mth follow-up, and 12-mth follow-up
|
Higher score means faster processing speed.
Range (0-100)
|
Baseline, 6-mth follow-up, and 12-mth follow-up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sara J. Czaja, PhD, Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1803019068
- 5R01AG054009 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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