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A Non-pharmacological Intervention for Patients With Alzheimer's Disease and Family Caregivers (Care Partners Program) (CPProgram)

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ClinicalTrials.gov Identifier: NCT03333252
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : September 14, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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 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.

Condition or disease Intervention/treatment Phase
Caregiver Behavioral: Intervention Condition Behavioral: Control Condition Not Applicable

Detailed Description:

We will recruit and randomly assign, following a baseline assessment, 200 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dual Target Program: An Non-pharmacological Intervention for Family Caregivers and Patients With Alzheimer's Disease
Actual Study Start Date : January 29, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2021


Arm Intervention/treatment
Experimental: Intervention Condition
Exposing caregivers to caregiving-related information and care recipients to cognitive training tasks
Behavioral: Intervention Condition
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.
Behavioral: Control Condition
Caregivers will access Nutrition and Health Promotion material. Care Recipients will access words and card games




Primary Outcome Measures :
  1. Decrease in depression score for caregiver as measured by CES-D [ Time Frame: Baseline, 6-mth follow-up and 12-mth follow-up ]
    Higher score means greater frequency of depressive symptoms. Range (0-30)


Secondary Outcome Measures :
  1. Decrease 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)


Other Outcome Measures:
  1. Increase 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)

  2. Increase 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)

  3. Increase 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)

  4. Increase 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)



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333252


Contacts
Contact: Chelsie Burchett, MA 212-746-1991 cob2014@med.cornell.edu

Locations
United States, Florida
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
United States, New York
Weill Cornell Medicine Not yet recruiting
New York, New York, United States, 10065
Contact: Chelsie Burchett, MA    212-746-1991    cob2014@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute on Aging (NIA)
Investigators
Principal Investigator: Sara J. Czaja, PhD Weill Cornell Medicine

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03333252     History of Changes
Other Study ID Numbers: 1803019068
5R01AG054009 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Weill Medical College of Cornell University:
Caregiver
Psycho-social intervention
Cognitive training
Quality of life
Early on-set Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders