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

NCT03333252 | Completed Results DMC

• 2 other identifiers: 18030190685R01AG054009
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 2

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.

Conditions

Caregiver

Keywords

Caregiver; Psycho-social intervention; Cognitive training; Quality of life; Early on-set Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Change in Depression Score for Caregiver as Measured by CES-D

  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 Outcomes (1)

• Change in Caregiving Burden Score for Caregiver as Measured by Burden Inventory

  Baseline, 6-mth follow-up and 12-mth follow-up

Other Outcomes (4)

• Change in Caregiver's Self Report of Self-care

  Baseline, 6-mth follow-up and 12-mth follow-up

• Change in Caregiver's Social Support

  Baseline, 6-mth follow-up and 12-mth follow-up

• Change in Care Recipient's Qualify of Life

  Baseline, 6-mth follow-up, and 12-mth follow-up

Study Arms (2)

Intervention Condition

EXPERIMENTAL

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

Behavioral: Intervention Condition

Control Condition

PLACEBO COMPARATOR

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

Behavioral: Control Condition

Interventions

Intervention Condition BEHAVIORAL

Caregivers will access caregiving related information. Care Recipients will access cognitive training program

Intervention Condition

Control Condition BEHAVIORAL

Caregivers will access Nutrition and Health Promotion material. Care Recipients will access words and card games

Control Condition

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not providing care to someone with memory problems
• Paid caregivers
• Has terminal illness with life expectancy of 6 months or less
• CARE RECIPIENT (CR)
• 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
• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Results Point of Contact

• Title: Sara J. Czaja
• Organization: Weill Medical College of Cornell University

sjc7004@med.cornell.edu

646-962-7141

Study Officials

• Sara J. Czaja, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 6, 2017
• Study Start: January 29, 2018
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: April 2, 2024
• Results First Posted: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)