DementiaMIND at HomeNCT02396082
MIND: Care Coordination for Community-living Person With Dementia
A study testing MIND-S Intervention in people with Dementia and Caregiver Burden, run by Johns Hopkins University at 1 site in United States.
Trial summary
This is a 24-month, prospective, single- blind, randomized controlled trial evaluating the MIND at Home-streamlined dementia care coordination intervention (called MIND-S) in a cohort of 300 community-living persons with dementia and their family caregivers in the Greater Baltimore area. Read more about this study
- Who is it for?
- Ages 21 to 120 years
- Conditions the study is for
- Dementia, Caregiver Burden
- What is being tested?
- MIND-S Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Apr 2020
- 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 21 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets criteria for all-cause dementia using standard assessments and diagnostic criteria
- English speaking
- Has a reliable informal caregiver available and willing to participate
- Living at home the Greater Baltimore area
Who cannot join
- Planned move from home in less than 6 months
- On hospice or has end stage disease (bed-bound and non-communicative)
- Enrolled in another clinical trial for dementia or associated symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MIND: An RCT of Care Coordination for Community-living Person With Dementia
This is a 24-month, prospective, single- blind, randomized controlled trial evaluating the MIND at Home-streamlined dementia care coordination intervention (called MIND-S) in a cohort of 300 community-living persons with dementia and their family caregivers in the Greater Baltimore area. Participants receiving MIND-S will get 18 months of care coordination by an interdisciplinary team comprised of trained memory care coordinators (non-clinical), a psychiatric nurse, and geriatric psychiatrist. The intervention involves 4 key components: identification of needs and individualized care planning (persons with dementia (PWD) and care giver (CG) needs); dementia education and skill building; coordination, referral and linkage of services; and care monitoring.Participants in the comparison group will receive an initial in-home needs assessment and will be given the written results along with any recommendations for care that are indicated.
Read the detailed description
Over 5 million older Americans currently suffer from Alzheimer's disease and related dementias with 80% receiving care in the community by 15 million informal caregivers (CGs) providing unpaid care. Dementia is associated with high health care costs, long term care (LTC) placement, medical complications, reduced quality of life, and CG burden. Patient and family centric care models tailored to dementia that address the multidimensional aspects of dementia management, and link health and community care are understudied but may represent a promising mechanism to address the multiple and on-going needs of this growing population, reduce adverse outcomes such as premature LTC placement, and produce cost benefits.
This is a definitive Phase III efficacy trial to test Maximizing Independence at Home-Streamlined (MIND-S), a home- based, care coordination intervention for community-living persons with dementia (PWD) and their family CGs that builds on pilot work. In a pilot trial, MIND at Home was successfully implemented in a diverse sample of 303 community-living individuals with memory disorders and was found to be acceptable to CGs, led to delays in time to transition from home, improved PWD quality of life, and CG time savings.
The current project is a 24-month, prospective, single- blind, parallel group, randomized controlled trial evaluating MIND-S in a cohort of 300 community-living PWD and their informal CGs in the Greater Baltimore area. Participants receiving MIND-S will get up to 18 months of care coordination by an interdisciplinary team comprised of trained memory care coordinators (non-clinical), a psychiatric nurse, and geriatric psychiatrist. The intervention involves 4 key components: identification of needs and individualized care planning (PWD and CG needs); dementia education and skill building; coordination, referral and linkage of services; and care monitoring.Participants in the comparison group will receive an initial in-home needs assessment and will be given the written results along with any recommendations for care that are indicated.
- Conditions
- Dementia, Caregiver Burden
- Being tested
- MIND-S Intervention, Augmented Usual Care
- Keywords
- care coordination, quality of life, community-based, care quality, Long term care placement, memory care, Neuropsychiatric behaviors
- Medical subject headings
- Dementia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIND-S InterventionBehavioural
Also called MIND at Home - Streamlined
MIND at Home is a home-based, care coordination that focuses on persons with dementia living at home and their family caregivers. Its goal is to help persons age in place safely while increasing quality of life. Delivered over 18 months, MIND systematically assesses and addresses unmet care needs of persons with dementia and their caregivers which are known to be linked to poor health and quality of life outcomes, and that put people at risk for long term care placement. The needs addressed in the MIND program cover a wide range of care domains, ranging from home and medication safety, to cognitive and behavior symptoms management, meaningful activities and legal considerations. The care team made up of a memory care coordinator, nurse, and physician. Patients and families receive care coordination assistance, resource referrals, dementia care education and behavior management skills training, emotional support and problem-solving, and home safety education
Augmented Usual CareOther
Augmented usual care consists of an initial full in-home needs assessment for dementia-related needs and a written report that identifies unmet needs and provides recommendations for care sent to the participant and the primary care physician. Augmented usual care participants also receive an Aging and Caregiver Resource Guide that includes program and contact information for several local and national aging service organizations (e.g., Alzheimer's Association, Administration on Aging, Centers for Medicare and Medicaid). This condition likely exceeds the usual level of intervention in primary care settings
| Study group | Role | What they receive |
|---|---|---|
| MIND-S Intervention | Experimental | Participants (persons with dementia (PWD) and their family caregiver (CG)) in this group will receive up to 18 months of the MIND-S dementia care coordination intervention by an interdisciplinary team comprised of trained memory care coordinators (non-clinical), a psychiatric nurse, and geriatric psychiatrist. The intervention involves 4 key components: identification of needs and individualized care planning (PWD and CG needs); dementia education and skill building; coordination, referral and linkage of services; and care monitoring. Receives: Behavioral: MIND-S Intervention |
| Augmented Usual Care | Other | Participants (persons with dementia (PWD) and their family caregiver (CG)) and their primary care physicians in this group will receive an initial in-home needs assessment and then a written report indicating any unmet care needs identified and potential recommendations of care for meeting those needs. They will be able to pursue any interventions or treatments they or their treating physicians deem appropriate. They will also receive a standardized Aging and Caregiver Resource Guide developed in the previous MIND trial. The study team will perform another in-home needs assessment at 18 months and the written report along with recommendations for care will be provided to the family and the PWD's primary care physician. Receives: Other: Augmented Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to long term care (LTC) placement or death
Time to long term care placement or death
Measured: 18 months
Secondary outcomes (15)
Cost-offset for total direct and indirect care costs
Estimates of cost-offset for the MIND-S program will be the cost-offset of MIND-S, defined as the net financial benefit of the program on total self-reported direct and indirect care costs. This will be calculated as the difference in the sum of all costs between MIND-S group and the sum of all costs in the augmented usual care from T1-T5 (baseline-18 months).
Measured: 18 months
Cost-offset for total direct and indirect care costs
Estimates of cost-offset for the MIND-S program will be the cost-offset of MIND-S, defined as the net financial benefit of the program on total self-reported direct and indirect care costs. This will be calculated as the difference in the sum of all costs between MIND-S group and the sum of all costs in the augmented usual care from T1-T6 (baseline-24 months).
Measured: 24 months
PWD unmet care needs
MIND at Home patient total unmet care needs as measured by the Johns Hopkins Dementia Care Needs Assessment 2.0 from baseline to 18 months compared to usual care group patient total unmet care needs from baseline to 18 months. (difference in slopes)
Measured: 18 months
PWD unmet care needs
MIND at Home patient total unmet care needs as measured by the Johns Hopkins Dementia Care Needs Assessment 2.0 from baseline to 24 months compared to usual care group patient total unmet care needs from baseline to 24 months. (difference in slopes)
Measured: 24 months
Neuropsychiatric symptoms (NPS)
MIND at Home patient Neuropsychiatric symptoms (NPS) as measured by the Neuropsychiatric Inventory-Questionnaire from baseline to 18 compared to usual care group patient NPS scores from baseline to 18 months. (difference in slopes)
Measured: 18 months
Neuropsychiatric symptoms (NPS)
MIND at Home patient Neuropsychiatric symptoms (NPS) as measured by the Neuropsychiatric Inventory-Questionnaire from baseline to 24 compared to usual care group patient NPS scores from baseline to 24 months (difference in slopes)
Measured: 24 months
Quality of life (QOL)
MIND at Home patient QOL as measured by the QOL-AD from baseline to 18 months compared to usual care group patient scores from baseline to 18 months (difference in slopes)
Measured: 18 months
Quality of life (QOL)
MIND at Home patient QOL as measured by the QOL-AD from baseline to 24 months compared to usual care group patient scores from baseline to 24 months (difference in slopes)
Measured: 24 months
Caregiver care unmet needs
MIND at Home caregiver total unmet care needs as measured by the Johns Hopkins Dementia Care Needs Assessment 2.0 from baseline to 18 months compared to usual care group patient total unmet care needs from baseline to 18 months. (difference in slopes)
Measured: 18 months
Caregiver care unmet needs
MIND at Home caregiver total unmet care needs as measured by the Johns Hopkins Dementia Care Needs Assessment 2.0 from baseline to 24 months compared to usual care group patient total unmet care needs from baseline to 24 months. (difference in slopes)
Measured: 24 months
Subjective caregiver burden
MIND at Home caregiver burden as measured by the Zarit Burden Interview from baseline to 18 months compared to usual care group patient burden from baseline to 18 months. (difference in slopes)
Measured: 18 months
Subjective caregiver burden
MIND at Home caregiver burden as measured by the Zarit Burden Interview from baseline to 24 months compared to usual care group caregiver burden scores from baseline to 24 months. (difference in slopes)
Measured: 24 months
Objective caregiver burden
MIND at Home caregiver burden as measured by time spent caregiving estimates from baseline to 18 months compared to usual care group time from baseline to 18 months. (difference in slopes)
Measured: 18 months
Objective caregiver burden
MIND at Home caregiver burden as measured by time spent caregiving estimates from baseline to 24 months compared to usual care group time from baseline to 24 months. (difference in slopes)
Measured: 24 months
Time to long term care (LTC) placement or death
Time to long term care placement or death
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startAug 2014
- Primary completionApr 2020
- Study completionApr 2020
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.
- More trials run by Johns Hopkins 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Quincy M Samus, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396082
- Sponsor's protocol ID
- IRB00041744
- Other IDs
- 90059611, 1R01AG046274-01A1
- Acronym
- MIND at Home
- Status last verified
- Jul 2021
- First submitted
- 10 Mar 2015
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIND: An RCT of Care Coordination for Community-living Person With Dementia
- ClinicalTrials.gov ID
- NCT02396082
- Acronym / sponsor ID
- MIND at Home / IRB00041744
- Conditions
- Dementia, Caregiver Burden
- Keywords
- care coordination, quality of life, community-based, care quality, Long term care placement, memory care, Neuropsychiatric behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Thomas Jefferson University, National Institute on Aging (NIA)
- Study start
- Aug 2014 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 24 Mar 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 is a 24-month, prospective, single- blind, randomized controlled trial evaluating the MIND at Home-streamlined dementia care coordination intervention (called MIND-S) in a cohort of 300 community-living persons with dementia and their family caregivers in the Greater Baltimore area. Participants receiving MIND-S will get 18 months of care coordination by an interdisciplinary team comprised of trained memory care coordinators (non-clinical), a psychiatric nurse, and geriatric psychiatrist. The intervention involves 4 key components: identification of needs and individualized care planning (persons with dementia (PWD) and care giver (CG) needs); dementia education and skill building; coordination, referral and linkage of services; and care monitoring.Participants in the comparison group will receive an initial in-home needs assessment and will be given the written results along with any recommendations for care that are indicated.
Detailed description
Over 5 million older Americans currently suffer from Alzheimer's disease and related dementias with 80% receiving care in the community by 15 million informal caregivers (CGs) providing unpaid care. Dementia is associated with high health care costs, long term care (LTC) placement, medical complications, reduced quality of life, and CG burden. Patient and family centric care models tailored to dementia that address the multidimensional aspects of dementia management, and link health and community care are understudied but may represent a promising mechanism to address the multiple and on-going needs of this growing population, reduce adverse outcomes such as premature LTC placement, and produce cost benefits.
This is a definitive Phase III efficacy trial to test Maximizing Independence at Home-Streamlined (MIND-S), a home- based, care coordination intervention for community-living persons with dementia (PWD) and their family CGs that builds on pilot work. In a pilot trial, MIND at Home was successfully implemented in a diverse sample of 303 community-living individuals with memory disorders and was found to be acceptable to CGs, led to delays in time to transition from home, improved PWD quality of life, and CG time savings.
The current project is a 24-month, prospective, single- blind, parallel group, randomized controlled trial evaluating MIND-S in a cohort of 300 community-living PWD and their informal CGs in the Greater Baltimore area. Participants receiving MIND-S will get up to 18 months of care coordination by an interdisciplinary team comprised of trained memory care coordinators (non-clinical), a psychiatric nurse, and geriatric psychiatrist. The intervention involves 4 key components: identification of needs and individualized care planning (PWD and CG needs); dementia education and skill building; coordination, referral and linkage of services; and care monitoring.Participants in the comparison group will receive an initial in-home needs assessment and will be given the written results along with any recommendations for care that are indicated.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIND-S Intervention | Experimental | Behavioral: MIND-S InterventionParticipants (persons with dementia (PWD) and their family caregiver (CG)) in this group will receive up to 18 months of the MIND-S dementia care coordination intervention by an interdisciplinary team comprised of trained memory care coordinators (non-clinical), a psychiatric nurse, and geriatric psychiatrist. The intervention involves 4 key components: identification of needs and individualized care planning (PWD and CG needs); dementia education and skill building; coordination, referral and linkage of services; and care monitoring. |
| Augmented Usual Care | Other | Other: Augmented Usual CareParticipants (persons with dementia (PWD) and their family caregiver (CG)) and their primary care physicians in this group will receive an initial in-home needs assessment and then a written report indicating any unmet care needs identified and potential recommendations of care for meeting those needs. They will be able to pursue any interventions or treatments they or their treating physicians deem appropriate. They will also receive a standardized Aging and Caregiver Resource Guide developed in the previous MIND trial. The study team will perform another in-home needs assessment at 18 months and the written report along with recommendations for care will be provided to the family and the PWD's primary care physician. |
Who may qualify
- Ages
- 21 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets criteria for all-cause dementia using standard assessments and diagnostic criteria
- English speaking
- Has a reliable informal caregiver available and willing to participate
- Living at home the Greater Baltimore area
Key exclusion criteria (3 listed)
- Planned move from home in less than 6 months
- On hospice or has end stage disease (bed-bound and non-communicative)
- Enrolled in another clinical trial for dementia or associated symptoms
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 |
|---|---|---|
| MIND-S InterventionAlso: MIND at Home - StreamlinedMIND at Home is a home-based, care coordination that focuses on persons with dementia living at home and their family caregivers. Its goal is to help persons age in place safely while increasing quality of life. Delivered over 18 months, MIND systematically assesses and addresses unmet care needs of persons with dementia and their caregivers which are known to be linked to poor health and quality of life outcomes, and that put people at risk for long term care placement. The needs addressed in the MIND program cover a wide range of care domains, ranging from home and medication safety, to cognitive and behavior symptoms management, meaningful activities and legal considerations. The care team made up of a memory care coordinator, nurse, and physician. Patients and families receive care coordination assistance, resource referrals, dementia care education and behavior management skills training, emotional support and problem-solving, and home safety education | Behavioural | MIND-S Intervention |
| Augmented Usual CareAugmented usual care consists of an initial full in-home needs assessment for dementia-related needs and a written report that identifies unmet needs and provides recommendations for care sent to the participant and the primary care physician. Augmented usual care participants also receive an Aging and Caregiver Resource Guide that includes program and contact information for several local and national aging service organizations (e.g., Alzheimer's Association, Administration on Aging, Centers for Medicare and Medicaid). This condition likely exceeds the usual level of intervention in primary care settings | Other | Augmented Usual Care |
Primary outcome
Time to long term care (LTC) placement or death
Time frame: 18 months
Time to long term care placement or death
15 secondary outcomes
Cost-offset for total direct and indirect care costs
Time frame: 18 months
Cost-offset for total direct and indirect care costs
Time frame: 24 months
PWD unmet care needs
Time frame: 18 months
PWD unmet care needs
Time frame: 24 months
Neuropsychiatric symptoms (NPS)
Time frame: 18 months
Neuropsychiatric symptoms (NPS)
Time frame: 24 months
Quality of life (QOL)
Time frame: 18 months
Quality of life (QOL)
Time frame: 24 months
Caregiver care unmet needs
Time frame: 18 months
Caregiver care unmet needs
Time frame: 24 months
Subjective caregiver burden
Time frame: 18 months
Subjective caregiver burden
Time frame: 24 months
Objective caregiver burden
Time frame: 18 months
Objective caregiver burden
Time frame: 24 months
Time to long term care (LTC) placement or death
Time frame: 24 months
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 16 Jul 2021.
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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.
Quincy M Samus, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIND-S Intervention in people with Dementia and Caregiver Burden, run by Johns Hopkins University 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 4 inclusion and 3 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 16 Jul 2021. 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?
Time to long term care (LTC) placement or death (time frame: 18 months). 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 16 Jul 2021.