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

Primary Purpose

Caregiver

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Condition
Control Condition
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caregiver focused on measuring Caregiver, Psycho-social intervention, Cognitive training, Quality of life, Early on-set Alzheimer's Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami Miller School of Medicine
  • Weill Cornell Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Condition

Control Condition

Arm Description

Exposing caregivers to caregiving-related information and care recipients to cognitive training tasks

Exposing caregivers to Nutrition and Health promotional material. The care recipients are exposed to plain words games from computer.

Outcomes

Primary Outcome Measures

Change in depression score for caregiver as measured by CES-D
Higher score means greater frequency of depressive symptoms. Range (0-30)

Secondary Outcome Measures

Change in caregiving burden score for caregiver as measured by Burden Inventory
Higher score means greater level of caregiver burden. Range (0-44)

Full Information

First Posted
November 2, 2017
Last Updated
May 23, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03333252
Brief Title
A Non-pharmacological Intervention for Patients With Alzheimer's Disease and Family Caregivers (Care Partners Program)
Acronym
CPProgram
Official Title
Dual Target Program: An Non-pharmacological Intervention for Family Caregivers and Patients With Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 29, 2018 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
May 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver
Keywords
Caregiver, Psycho-social intervention, Cognitive training, Quality of life, Early on-set Alzheimer's Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
352 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Condition
Arm Type
Experimental
Arm Description
Exposing caregivers to caregiving-related information and care recipients to cognitive training tasks
Arm Title
Control Condition
Arm Type
Placebo Comparator
Arm Description
Exposing caregivers to Nutrition and Health promotional material. The care recipients are exposed to plain words games from computer.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Condition
Intervention Description
Caregivers will access caregiving related information. Care Recipients will access cognitive training program
Intervention Type
Behavioral
Intervention Name(s)
Control Condition
Intervention Description
Caregivers will access Nutrition and Health Promotion material. Care Recipients will access words and card games
Primary Outcome Measure Information:
Title
Change in depression score for caregiver as measured by CES-D
Description
Higher score means greater frequency of depressive symptoms. Range (0-30)
Time Frame
Baseline, 6-mth follow-up and 12-mth follow-up
Secondary Outcome Measure Information:
Title
Change in caregiving burden score for caregiver as measured by Burden Inventory
Description
Higher score means greater level of caregiver burden. Range (0-44)
Time Frame
Baseline, 6-mth follow-up and 12-mth follow-up
Other Pre-specified Outcome Measures:
Title
Change in caregiver's self report of Self-care
Description
Higher score means better in keeping medical obligations to him/herself. Range (0-12)
Time Frame
Baseline, 6-mth follow-up and 12-mth follow-up
Title
Change in caregiver's Social Support
Description
Higher score means more social support for the caregiver. Range (0-40)
Time Frame
Baseline, 6-mth follow-up and 12-mth follow-up
Title
Change in care recipient's Qualify of Life
Description
Higher score means better quality of life as Alzheimer's patient. Range (0-52)
Time Frame
Baseline, 6-mth follow-up, and 12-mth follow-up
Title
Change in care recipient's processing speed using Digit Symbol test
Description
Higher score means faster processing speed. Range (0-100)
Time Frame
Baseline, 6-mth follow-up, and 12-mth follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara J. Czaja, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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