Skip to content

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

Dual Target Program: An Non-pharmacological Intervention for Family Caregivers and Patients With Alzheimer's Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03333252
Acronym
CPProgram
Enrollment
352
Registered
2017-11-06
Start date
2018-01-29
Completion date
2023-05-01
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiver

Keywords

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

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.

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.

Interventions

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

BEHAVIORALControl Condition

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

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Depression Score for Caregiver as Measured by CES-DBaseline, 6-mth follow-up and 12-mth follow-upHigher score on the Center for Epidemiological Studies Depression scale (CES-D) means greater frequency of depressive symptoms. Range (0-30)

Secondary

MeasureTime frameDescription
Change in Caregiving Burden Score for Caregiver as Measured by Burden InventoryBaseline, 6-mth follow-up and 12-mth follow-upHigher score means greater level of caregiver burden. Range (0-44)

Other

MeasureTime frameDescription
Change in Caregiver's Self Report of Self-careBaseline, 6-mth follow-up and 12-mth follow-upHigher score means better in keeping medical obligations to him/herself. Range (0-12)
Change in Caregiver's Social SupportBaseline, 6-mth follow-up and 12-mth follow-upHigher score means more social support for the caregiver. Range (0-40)
Change in Care Recipient's Qualify of LifeBaseline, 6-mth follow-up, and 12-mth follow-upHigher score means better quality of life as Alzheimer's patient. Range (0-52)
Change in Care Recipient's Processing Speed Using Digit Symbol TestBaseline, 6-mth follow-up, and 12-mth follow-upHigher score means faster processing speed. Range (0-100)

Countries

United States

Participant flow

Participants by arm

ArmCount
Care Recipients - Intervention Condition
Exposing care recipients to cognitive training tasks
89
Care Recipients - Control Condition
Exposing care recipients to plain words games from computer.
87
Caregivers - Intervention Condition
Exposing caregivers to caregiving-related information.
89
Caregivers - Control Condition
Exposing caregivers to Nutrition and Health promotional material.
87
Total352

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyAdverse Event10652
Overall StudyDeath1300
Overall StudyLack of Efficacy8407
Overall StudyLost to Follow-up0593
Overall StudyWithdrawal by Subject14241117

Baseline characteristics

CharacteristicCare Recipients - Intervention ConditionCare Recipients - Control ConditionCaregivers - Intervention ConditionCaregivers - Control ConditionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
88 Participants84 Participants46 Participants51 Participants269 Participants
Age, Categorical
Between 18 and 65 years
1 Participants3 Participants43 Participants36 Participants83 Participants
Age, Continuous81 years81 years65 years67 years75 years
Change in depression score for caregiver as measured by CES-D9 units on a scale10 units on a scale10 units on a scale
Ethnicity (NIH/OMB)
Hispanic or Latino
16 Participants19 Participants19 Participants18 Participants72 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
73 Participants68 Participants70 Participants69 Participants280 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
5 Participants0 Participants4 Participants0 Participants9 Participants
Race (NIH/OMB)
Black or African American
7 Participants8 Participants6 Participants7 Participants28 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants7 Participants2 Participants7 Participants18 Participants
Race (NIH/OMB)
White
75 Participants70 Participants77 Participants73 Participants295 Participants
Region of Enrollment
United States
89 participants87 participants89 participants87 participants352 participants
Sex/Gender, Customized
Female
40 Participants34 Participants74 Participants76 Participants224 Participants
Sex/Gender, Customized
Male
49 Participants52 Participants15 Participants11 Participants127 Participants
Sex/Gender, Customized
Other
0 Participants1 Participants0 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
1 / 893 / 870 / 890 / 87
other
Total, other adverse events
7 / 8918 / 8726 / 8916 / 87
serious
Total, serious adverse events
11 / 8912 / 872 / 895 / 87

Outcome results

Primary

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)

Time frame: Baseline, 6-mth follow-up and 12-mth follow-up

Population: This measure was only administered to caregivers. Missing data is due to participants either lost to follow up or withdrew between the baseline assessment and 12 month assessment.

ArmMeasureGroupValue (MEDIAN)
Caregivers - Intervention ConditionChange in Depression Score for Caregiver as Measured by CES-D12 month9 units on a scale
Caregivers - Intervention ConditionChange in Depression Score for Caregiver as Measured by CES-Dbaseline9 units on a scale
Caregivers - Intervention ConditionChange in Depression Score for Caregiver as Measured by CES-D6 month9 units on a scale
Caregivers - Control ConditionChange in Depression Score for Caregiver as Measured by CES-D12 month9 units on a scale
Caregivers - Control ConditionChange in Depression Score for Caregiver as Measured by CES-Dbaseline10 units on a scale
Caregivers - Control ConditionChange in Depression Score for Caregiver as Measured by CES-D6 month8 units on a scale
Secondary

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

Higher score means greater level of caregiver burden. Range (0-44)

Time frame: Baseline, 6-mth follow-up and 12-mth follow-up

Population: This measure was only administered to caregivers. Additionally, missing data is due to some participants either being lost to follow up or withdrew between the baseline assessment and 12 month assessment.

ArmMeasureGroupValue (MEDIAN)
Caregivers - Intervention ConditionChange in Caregiving Burden Score for Caregiver as Measured by Burden InventoryBaseline18 score on a scale
Caregivers - Intervention ConditionChange in Caregiving Burden Score for Caregiver as Measured by Burden Inventory6 month16 score on a scale
Caregivers - Intervention ConditionChange in Caregiving Burden Score for Caregiver as Measured by Burden Inventory12 month15.6 score on a scale
Caregivers - Control ConditionChange in Caregiving Burden Score for Caregiver as Measured by Burden InventoryBaseline18 score on a scale
Caregivers - Control ConditionChange in Caregiving Burden Score for Caregiver as Measured by Burden Inventory6 month15 score on a scale
Caregivers - Control ConditionChange in Caregiving Burden Score for Caregiver as Measured by Burden Inventory12 month17 score on a scale
Other Pre-specified

Change in Caregiver's Self Report of Self-care

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

Population: This measure was only administered to caregivers. Additionally, missing data is due to some participants being either lost to follow up or withdrew between the baseline assessment and 12 month assessment.

ArmMeasureGroupValue (MEDIAN)
Caregivers - Intervention ConditionChange in Caregiver's Self Report of Self-care12 month8 units on a scale
Caregivers - Intervention ConditionChange in Caregiver's Self Report of Self-careBaseline6 units on a scale
Caregivers - Intervention ConditionChange in Caregiver's Self Report of Self-care6 month6.6 units on a scale
Caregivers - Control ConditionChange in Caregiver's Self Report of Self-care6 month6 units on a scale
Caregivers - Control ConditionChange in Caregiver's Self Report of Self-care12 month8 units on a scale
Caregivers - Control ConditionChange in Caregiver's Self Report of Self-careBaseline6 units on a scale
Other Pre-specified

Change in Caregiver's Social Support

Higher score means more social support for the caregiver. Range (0-40)

Time frame: Baseline, 6-mth follow-up and 12-mth follow-up

Population: This measure was only administered to caregivers. Additionally, missing data is due to some participants being either lost to follow up or withdrew between the baseline assessment and 12 month assessment.

ArmMeasureGroupValue (MEDIAN)
Caregivers - Intervention ConditionChange in Caregiver's Social SupportBaseline22 units on a scale
Caregivers - Intervention ConditionChange in Caregiver's Social Support6 month21 units on a scale
Caregivers - Intervention ConditionChange in Caregiver's Social Support12 month21.5 units on a scale
Caregivers - Control ConditionChange in Caregiver's Social SupportBaseline23 units on a scale
Caregivers - Control ConditionChange in Caregiver's Social Support6 month23 units on a scale
Caregivers - Control ConditionChange in Caregiver's Social Support12 month22 units on a scale
Other Pre-specified

Change in Care Recipient's Processing Speed Using Digit Symbol Test

Higher score means faster processing speed. Range (0-100)

Time frame: Baseline, 6-mth follow-up, and 12-mth follow-up

Population: This measure was only administered to care recipients. Additionally, missing data is due to some participants being either lost to follow up or withdrew between the baseline assessment and 12 month assessment.

ArmMeasureGroupValue (MEDIAN)
Care Recipients - Intervention ConditionChange in Care Recipient's Processing Speed Using Digit Symbol TestBaseline15 units on a scale
Care Recipients - Intervention ConditionChange in Care Recipient's Processing Speed Using Digit Symbol Test6 months25 units on a scale
Care Recipients - Intervention ConditionChange in Care Recipient's Processing Speed Using Digit Symbol Test12 months20 units on a scale
Care Recipients - Control ConditionChange in Care Recipient's Processing Speed Using Digit Symbol Test12 months23 units on a scale
Care Recipients - Control ConditionChange in Care Recipient's Processing Speed Using Digit Symbol TestBaseline27 units on a scale
Care Recipients - Control ConditionChange in Care Recipient's Processing Speed Using Digit Symbol Test6 months28 units on a scale
Other Pre-specified

Change in Care Recipient's Qualify of Life

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

Population: This measure was only administered to care recipients. Additionally, missing data is due to some participants being either lost to follow up or withdrew between the baseline assessment and 12 month assessment.

ArmMeasureGroupValue (MEDIAN)
Care Recipients - Intervention ConditionChange in Care Recipient's Qualify of LifeBaseline33 units on a scale
Care Recipients - Intervention ConditionChange in Care Recipient's Qualify of Life6 month33 units on a scale
Care Recipients - Intervention ConditionChange in Care Recipient's Qualify of Life12 month33 units on a scale
Care Recipients - Control ConditionChange in Care Recipient's Qualify of LifeBaseline32 units on a scale
Care Recipients - Control ConditionChange in Care Recipient's Qualify of Life6 month32 units on a scale
Care Recipients - Control ConditionChange in Care Recipient's Qualify of Life12 month33 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026