MIND: Care Coordination for Community-living Person With Dementia
- Conditions
- Caregiver BurdenDementia
- Interventions
- Behavioral: MIND-S InterventionOther: Augmented Usual Care
- Registration Number
- NCT02396082
- Lead Sponsor
- Johns Hopkins University
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MIND-S Intervention MIND-S Intervention 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. Augmented Usual Care Augmented Usual Care 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.
- Primary Outcome Measures
Name Time Method Time to long term care (LTC) placement or death 18 months Time to long term care placement or death
- Secondary Outcome Measures
Name Time Method Neuropsychiatric symptoms (NPS) 24 months 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)
PWD unmet care needs 24 months 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)
Objective caregiver burden 24 months 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)
Caregiver care unmet needs 24 months 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)
Quality of life (QOL) 24 months 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)
Time to long term care (LTC) placement or death 24 months Time to long term care placement or death
Subjective caregiver burden 24 months 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)
Cost-offset for total direct and indirect care costs 24 months 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).
Trial Locations
- Locations (1)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States