DementiaNCT02552563
Engaging Caregivers in Dementia Care
A study testing Dementia Care Management in people with Dementia, run by Corporal Michael J. Crescenz VA Medical Center at 1 site in United States.
Trial summary
This pilot study seeks to examine the extent to which, relative to usual care, a dementia care management program for veterans and their caregivers (CGs)improves patient (e.g., behavioral symptoms, delayed nursing home placement) and caregiver (e.g., CG mastery, burden, affect) outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Dementia Care Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient and caregiver 18 years of age or older
- Patient is community dwelling
- Patient has a confirmed dementia diagnosis and/or significant cognitive impairment (per provider or CG report) that is verified upon the RA's cognitive screening assessment (per veteran (BOMC, score of 16 or above) or informant (AD8, score of 2 or above) and/or chart review
- CG lives with and/or provides care for the patient for an average of at least 4 hours per day.
- Veteran provides assent to contact his/her representative to pursue study participation
- Veteran representative as caregiver is willing and able to provide informed consent
Who cannot join
- Cognitive, hearing, visual, or other physical impairments leading to difficulty with assent/ informed consent process and/or assessment (veteran or caregiver)
Trial locations and contacts
1 site in 1 country.
United States1 site
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Engaging Caregivers in the Care of Veterans With Dementia
This pilot study seeks to examine the extent to which, relative to usual care, a dementia care management program for veterans and their caregivers (CGs)improves patient (e.g., behavioral symptoms, delayed nursing home placement) and caregiver (e.g., CG mastery, burden, affect) outcomes.
Read the detailed description
Dementia care guidelines and pharmacological and non-pharmacological treatments have been shown to reduce symptom burden and rates of institutionalization for individuals with dementia. However, there remain a variety of factors that complicate dementia care management in primary care settings. Patient-centered, integrated care management programs that involve caregiver (CG) education and psychosocial support may help facilitate access to and use of services and improve outcomes. The aims of this pilot were to examine 1) whether, relative to usual care (UC), a dementia care management program is associated with improved CG (e.g., mastery, burden, affect) and patient (e.g., behavioral symptoms) outcomes, 2) if, relative to UC, participants enrolled in the program have greater perceived access to and use of medical, social, and community/VA services, and 3) whether the dementia care management program is feasible and acceptable to participants.
- Conditions
- Dementia
- Being tested
- Dementia Care Management
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dementia Care ManagementBehavioural
Also called Telehealth Education Program
The intervention involves two main components. The first component includes individualized dementia care management that involves regular and extended contact between the CG, care manager, and when appropriate, Veteran's primary care provider (PCP). The care manager monitors Veterans' symptoms via CG report, provides psychoeducation and support to CGs, influences adherence to guidelines by providing timely and tailored information to PCPs, and suggests appropriate care strategies and service referrals. The second major component is the Telehealth Education Program (TEP). For this pilot study, the program was modified for use with individual CGs and was formatted so that CGs could select from a menu of up to 7 modules covering various content areas evaluated during the course of the care management assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, long-term planning, etc.).
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Standard care received by veterans in the Corporal Michael J. Crescenz VA Medical Center |
| Dementia Care Management | Active comparator | CG education, continuous support, communication and coping skills training, and veteran monitoring, via CG report, of medication, symptoms, and service needs. Receives: Behavioral: Dementia Care Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Memory and Behavior Problems Checklist (RMBPC)
Frequency of care recipient dementia-related behaviors and associated caregiver distress
Measured: Change in frequency and distress from baseline to 3 and 6 month follow-up
Neuropsychiatric Inventory Questionnaire (NPI-Q)
Frequency of care recipient neuropsychiatric symptoms and associated caregiver distress
Measured: Change in frequency and distress from baseline to 3 and 6 month follow-up
Zarit Burden Interview
Perceived caregiver burden
Measured: Change in burden from baseline to 3 and 6 month follow-up
Secondary outcomes (2)
Pearlin Stress and Coping Scale
Caregiver coping strategies
Measured: Change in coping skills from baseline to 3 and 6 month follow-up
Lawton Caregiving and Stress Process Scales
Caregiver mastery
Measured: Change in caregiver mastery from baseine to 3 and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startFeb 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporal Michael J. Crescenz VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Shahrzad Mavandadi, Corporal Michael J. Crescenz VA Medical Center
- Investigators
- Shahrzad Mavandadi, PhD, Principal investigator, Corporal Michael J. Crescenz VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552563
- Sponsor's protocol ID
- 01247
- Status last verified
- Sep 2022
- First submitted
- 4 Sep 2015
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Caregivers in the Care of Veterans With Dementia
- ClinicalTrials.gov ID
- NCT02552563
- Acronym / sponsor ID
- 01247
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Corporal Michael J. Crescenz VA Medical CenterUS federal agency
- Study start
- Feb 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study seeks to examine the extent to which, relative to usual care, a dementia care management program for veterans and their caregivers (CGs)improves patient (e.g., behavioral symptoms, delayed nursing home placement) and caregiver (e.g., CG mastery, burden, affect) outcomes.
Detailed description
Dementia care guidelines and pharmacological and non-pharmacological treatments have been shown to reduce symptom burden and rates of institutionalization for individuals with dementia. However, there remain a variety of factors that complicate dementia care management in primary care settings. Patient-centered, integrated care management programs that involve caregiver (CG) education and psychosocial support may help facilitate access to and use of services and improve outcomes. The aims of this pilot were to examine 1) whether, relative to usual care (UC), a dementia care management program is associated with improved CG (e.g., mastery, burden, affect) and patient (e.g., behavioral symptoms) outcomes, 2) if, relative to UC, participants enrolled in the program have greater perceived access to and use of medical, social, and community/VA services, and 3) whether the dementia care management program is feasible and acceptable to participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Standard care received by veterans in the Corporal Michael J. Crescenz VA Medical Center |
| Dementia Care Management | Active comparator | Behavioral: Dementia Care ManagementCG education, continuous support, communication and coping skills training, and veteran monitoring, via CG report, of medication, symptoms, and service needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient and caregiver 18 years of age or older
- Patient is community dwelling
- Patient has a confirmed dementia diagnosis and/or significant cognitive impairment (per provider or CG report) that is verified upon the RA's cognitive screening assessment (per veteran (BOMC, score of 16 or above) or informant (AD8, score of 2 or above) and/or chart review
- CG lives with and/or provides care for the patient for an average of at least 4 hours per day.
- Veteran provides assent to contact his/her representative to pursue study participation
Key exclusion criteria (1 listed)
- Cognitive, hearing, visual, or other physical impairments leading to difficulty with assent/ informed consent process and/or assessment (veteran or caregiver)
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 |
|---|---|---|
| Dementia Care ManagementAlso: Telehealth Education ProgramThe intervention involves two main components. The first component includes individualized dementia care management that involves regular and extended contact between the CG, care manager, and when appropriate, Veteran's primary care provider (PCP). The care manager monitors Veterans' symptoms via CG report, provides psychoeducation and support to CGs, influences adherence to guidelines by providing timely and tailored information to PCPs, and suggests appropriate care strategies and service referrals. The second major component is the Telehealth Education Program (TEP). For this pilot study, the program was modified for use with individual CGs and was formatted so that CGs could select from a menu of up to 7 modules covering various content areas evaluated during the course of the care management assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, long-term planning, etc.). | Behavioural | Dementia Care Management |
Primary outcome
Revised Memory and Behavior Problems Checklist (RMBPC)
Time frame: Change in frequency and distress from baseline to 3 and 6 month follow-up
Frequency of care recipient dementia-related behaviors and associated caregiver distress
Neuropsychiatric Inventory Questionnaire (NPI-Q)
Time frame: Change in frequency and distress from baseline to 3 and 6 month follow-up
Frequency of care recipient neuropsychiatric symptoms and associated caregiver distress
Zarit Burden Interview
Time frame: Change in burden from baseline to 3 and 6 month follow-up
Perceived caregiver burden
2 secondary outcomes
Pearlin Stress and Coping Scale
Time frame: Change in coping skills from baseline to 3 and 6 month follow-up
Lawton Caregiving and Stress Process Scales
Time frame: Change in caregiver mastery from baseine to 3 and 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
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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.
Shahrzad Mavandadi, PhD principal investigator
Corporal Michael J. Crescenz VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dementia Care Management in people with Dementia, run by Corporal Michael J. Crescenz VA Medical Center at 1 site 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 6 inclusion and 1 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 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Revised Memory and Behavior Problems Checklist (RMBPC) (time frame: Change in frequency and distress from baseline to 3 and 6 month follow-up). The study lists 3 primary outcomes in all. 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 28 Sep 2022.