N/A
N=352
A Non-pharmacological Intervention for Patients With Alzheimer's Disease and Family Caregivers (Care Partners Program)
Caregiver
Bottom Line
View on ClinicalTrials.gov: NCT03333252 ↗Enrolled (actual)
352
Serious AEs
8.5%
Results posted
Apr 2024
Primary outcome: Primary: Change in Depression Score for Caregiver as Measured by CES-D — 9; 10; 9; 8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intervention Condition (Behavioral); Control Condition (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Depression Score for Caregiver as Measured by CES-D |
9; 10; 9; 8; 9; 9 | — |
| SECONDARY Change in Caregiving Burden Score for Caregiver as Measured by Burden Inventory |
18; 18; 16; 15; 15.6; 17 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03333252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.