CaregiverCPProgramNCT03333252
A Non-pharmacological Intervention for Patients With Alzheimer's Disease and Family Caregivers (Care Partners Program)
A study testing Intervention Condition in people with Caregiver, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Caregiver
- What is being tested?
- Intervention Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jan 2018to 1 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Not providing care to someone with memory problems
- Paid caregivers
- Has terminal illness with life expectancy of 6 months or less
- CARE RECIPIENT (CR)
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami Miller School of Medicine
Miami, Florida, 33136
Weill Cornell Medicine
New York, New York, 10065
About this study
Official title: Dual Target Program: An Non-pharmacological Intervention for Family Caregivers and Patients With Alzheimer's Disease
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.
Read the 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.
- Conditions
- Caregiver
- Being tested
- Intervention Condition, Control Condition
- Keywords
- Caregiver, Psycho-social intervention, Cognitive training, Quality of life, Early on-set Alzheimer's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ConditionBehavioural
Caregivers will access caregiving related information. Care Recipients will access cognitive training program
Control ConditionBehavioural
Caregivers will access Nutrition and Health Promotion material. Care Recipients will access words and card games
| Study group | Role | What they receive |
|---|---|---|
| Intervention Condition | Experimental | Exposing caregivers to caregiving-related information and care recipients to cognitive training tasks Receives: 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. Receives: Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Higher score means greater level of caregiver burden. Range (0-44)
Measured: Baseline, 6-mth follow-up and 12-mth follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start29 Jan 2018
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Sara J. Czaja, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333252
- Sponsor's protocol ID
- 1803019068
- Other IDs
- 5R01AG054009
- Acronym
- CPProgram
- Status last verified
- Mar 2024
- First submitted
- 2 Nov 2017
- Last updated
- 2 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Target Program: An Non-pharmacological Intervention for Family Caregivers and Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03333252
- Acronym / sponsor ID
- CPProgram / 1803019068
- Conditions
- Caregiver
- Keywords
- Caregiver, Psycho-social intervention, Cognitive training, Quality of life, Early on-set Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Posted 2 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Experimental | Behavioral: Intervention ConditionExposing caregivers to caregiving-related information and care recipients to cognitive training tasks |
| Control Condition | Placebo comparator | Behavioral: Control ConditionExposing caregivers to Nutrition and Health promotional material. The care recipients are exposed to plain words games from computer. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- Not providing care to someone with memory problems
- Paid caregivers
- Has terminal illness with life expectancy of 6 months or less
- CARE RECIPIENT (CR)
- Lives in nursing home or facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention ConditionCaregivers will access caregiving related information. Care Recipients will access cognitive training program | Behavioural | Intervention Condition |
| Control ConditionCaregivers will access Nutrition and Health Promotion material. Care Recipients will access words and card games | Behavioural | Control Condition |
Primary outcome
Change in Depression Score for Caregiver as Measured by CES-D
Time frame: Baseline, 6-mth follow-up and 12-mth follow-up
Higher score on the Center for Epidemiological Studies Depression scale (CES-D) means greater frequency of depressive symptoms. Range (0-30)
1 secondary outcome
Change in Caregiving Burden Score for Caregiver as Measured by Burden Inventory
Time frame: Baseline, 6-mth follow-up and 12-mth follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara J. Czaja, PhD principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Condition in people with Caregiver, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression Score for Caregiver as Measured by CES-D (time frame: Baseline, 6-mth follow-up and 12-mth follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.