NCT02396082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

5.7 years

First QC Date

March 10, 2015

Last Update Submit

July 15, 2021

Conditions

DementiaCaregiver Burden

Keywords

care coordinationquality of lifecommunity-basedcare qualityLong term care placementmemory careNeuropsychiatric behaviors

Outcome Measures

Primary Outcomes (1)

  • Time to long term care (LTC) placement or death

    Time to long term care placement or death

    18 months

Secondary Outcomes (15)

  • Cost-offset for total direct and indirect care costs

    18 months

  • Cost-offset for total direct and indirect care costs

    24 months

  • PWD unmet care needs

    18 months

  • PWD unmet care needs

    24 months

  • Neuropsychiatric symptoms (NPS)

    18 months

  • +10 more secondary outcomes

Study Arms (2)

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.

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.

Other: Augmented Usual Care

Interventions

MIND-S InterventionBEHAVIORAL

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

Also known as: MIND at Home - Streamlined
MIND-S Intervention
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

Augmented Usual Care

Eligibility Criteria

Age21 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

DementiaCaregiver Burden

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Quincy M Samus, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 24, 2015

Study Start

August 1, 2014

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

July 16, 2021

Record last verified: 2021-07

Locations

US(1)