Clinical trial NCT02396082: MIND: Care Coordination for Community-living Person With Dementia
Official title: MIND: An RCT of Care Coordination for Community-living Person With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Caregiver Burden
Keywords: care coordination
quality of life
community-based
care quality
Long term care placement
memory care
Neuropsychiatric behaviors
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
name: National Institute on Aging (NIA)
First posted: 2015-03-24
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria for PWD:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time to long term care (LTC) placement or death
timeFrame: 18 months
Secondary outcomes:
measure: Cost-offset for total direct and indirect care costs
timeFrame: 18 months
measure: Cost-offset for total direct and indirect care costs
timeFrame: 24 months
measure: PWD unmet care needs
timeFrame: 18 months
measure: PWD unmet care needs
timeFrame: 24 months
measure: Neuropsychiatric symptoms (NPS)
timeFrame: 18 months
measure: Neuropsychiatric symptoms (NPS)
timeFrame: 24 months
measure: Quality of life (QOL)
timeFrame: 18 months
measure: Quality of life (QOL)
timeFrame: 24 months
measure: Caregiver care unmet needs
timeFrame: 18 months
measure: Caregiver care unmet needs
timeFrame: 24 months
measure: Subjective caregiver burden
timeFrame: 18 months
measure: Subjective caregiver burden
timeFrame: 24 months
measure: Objective caregiver burden
timeFrame: 18 months
measure: Objective caregiver burden
timeFrame: 24 months
measure: Time to long term care (LTC) placement or death
timeFrame: 24 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Quincy M Samus, PhD
role: PRINCIPAL_INVESTIGATOR
References: