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Memory DisordersPhase 2/3NCT01283750

Maximizing Independence at Home (MIND at Home)

A Phase 2/3 study testing care coordination in people with Memory Disorders and Dementia, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Funded by a unique private philanthropy and public coalition through THE ASSOCIATED: Jewish Community Federation of Baltimore, this project seeks to develop effective ways to deliver dementia care to older adults with memory disorders who live in the community. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Memory Disorders, Dementia
What is being tested?
care coordination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
303 participants
Where
1 siteUnited States
Study dates
Jul 2008to Dec 2012
Phase
Phase 2/3
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 70+ years old
  • Community living (within one of 28 zip codes in Baltimore)
  • Has memory disorder
  • Has identified study partner willing to participate
  • English-speaking

Who cannot join

  • Situation at the time of referral is an emergency with risk of danger to individual or others
  • Presence of delirium or other rule outs for memory disorder

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins University

    Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: Maximizing Independence at Home (MIND at Home): Dementia Care at Home Study

Funded by a unique private philanthropy and public coalition through THE ASSOCIATED: Jewish Community Federation of Baltimore, this project seeks to develop effective ways to deliver dementia care to older adults with memory disorders who live in the community. MIND at Home is an 18 month intervention research study whose goals are two-fold: To partner with community organizations to help proactively identify older adults in the Baltimore community who may need help related to memory disorders; To find out if providing person-centered, coordinated care will help older adults with memory disorders remain at home longer, as well other possible benefits. The investigators hypothesize that individuals with memory disorders that receive person-centered, coordinated care will have fewer unmet dementia-related needs, improved quality of life and function, fewer behavioral and depressive symptoms, and will be able to remain in their homes longer compared to individuals who receive augmented usual care.

Being tested
care coordination
Keywords
care coordination, dementia care, intervention, unmet needs, community, older adults, caregiver
Medical subject headings
Memory Disorders, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • care coordinationBehavioural

    dementia-related care coordination

Study groups in NCT01283750
Study groupRoleWhat they receive
Augmented Usual CareNo interventionNot described
Receives: Behavioral: care coordination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in unmet dementia-related needs from Baseline to 18 months

    Unmet dementia-related needs as measured by the Johns Hopkins Dementia Care Needs Assessment (JHDCNA), clinican-based assessment of 21 domains (92 individual items)

    Measured: 18 months

Secondary outcomes (6)

  1. Change in quality of life from Baseline to 18 months

    Participant quality of life measured by Quality of Life in Alzheimers Disease (QOL-AD) and Alzheimer's Disease Related Quality of life scale (ADRQL). Caregiver quality of life measured by SF-12.

    Measured: 18 month

  2. length of stay

    Length of stay in the community assessed by number of days from initial study assessment to end of study observation or to date that the subject leaves their community-based residence (e.g. move to nursing home, assisted living, death) prior to end of study observation.

    Measured: 18 months

  3. neuropsychiatric behavior symptoms from baseline to 18 months

    Neuropsychiatric behavior measured by the Neuropsychiatry Inventory Questionnaire

    Measured: 18 month

  4. day-to-day function from baseline to 18 months

    Day-to-day function assessed by the Instrumental Activities of Daily Living Scale and the Psycho-geriatric Dependency Rating Scale

    Measured: 18 month

  5. health care utilization from baseline to 18 months

    Inpatient, residential, Alzheimer Disease-related, mental health, and medical health care use measured by the SURFS

    Measured: 18 month

  6. depression from baseline to 18 months

    Participant depression measured by the Cornell Scale for Depression (CSDD) in Dementia. Caregiver depression measured by the Geriatric Depression Scale (GDS).

    Measured: 18 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2011 (estimated)
  2. Study startJul 2008
  3. Primary completionDec 2011
  4. Study completionDec 2012

Resources

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 2/3
Primary purpose
Treatment
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01283750
Sponsor's protocol ID
NA_00012829
Other IDs
90032824
Status last verified
Nov 2018
First submitted
24 Jan 2011
Last updated
6 Nov 2018
Results posted
No

Publications

  • Johnston D, Samus QM, Morrison A, Leoutsakos JS, Hicks K, Handel S, Rye R, Robbins B, Rabins PV, Lyketsos CG, Black BS. Identification of community-residing individuals with dementia and their unmet needs for care. Int J Geriatr Psychiatry. 2011 Mar;26(3):292-8. doi: 10.1002/gps.2527. Epub 2010 Jul 23.

    PubMed 20658473

  • Marquardt G, Johnston D, Black BS, Morrison A, Rosenblatt A, Lyketsos CG, Samus QM. Association of the spatial layout of the home and ADL abilities among older adults with dementia. Am J Alzheimers Dis Other Demen. 2011 Feb;26(1):51-7. doi: 10.1177/1533317510387584.

    PubMed 21282278

  • Marquardt G, Johnston D, Black BS, Morrison A, Rosenblatt A, Lyketsos CG, Samus QM. A Descriptive Study of Home Modifications for People with Dementia and Barriers to Implementation. J Hous Elderly. 2011 Jan 1;25(3):258-273. doi: 10.1080/02763893.2011.595612.

    PubMed 21904419

  • Black BS, Johnston D, Morrison A, Rabins PV, Lyketsos CG, Samus QM. Quality of life of community-residing persons with dementia based on self-rated and caregiver-rated measures. Qual Life Res. 2012 Oct;21(8):1379-89. doi: 10.1007/s11136-011-0044-z. Epub 2011 Oct 26.

    PubMed 22038392

  • Samus QM, Johnston D, Black BS, Hess E, Lyman C, Vavilikolanu A, Pollutra J, Leoutsakos JM, Gitlin LN, Rabins PV, Lyketsos CG. A multidimensional home-based care coordination intervention for elders with memory disorders: the maximizing independence at home (MIND) pilot randomized trial. Am J Geriatr Psychiatry. 2014 Apr;22(4):398-414. doi: 10.1016/j.jagp.2013.12.175. Epub 2014 Jan 4.

    PubMed 24502822

  • Black BS, Johnston D, Rabins PV, Morrison A, Lyketsos C, Samus QM. Unmet needs of community-residing persons with dementia and their informal caregivers: findings from the maximizing independence at home study. J Am Geriatr Soc. 2013 Dec;61(12):2087-2095. doi: 10.1111/jgs.12549.

    PubMed 24479141

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing care coordination in people with Memory Disorders and Dementia, 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 5 inclusion and 2 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 6 Nov 2018. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in unmet dementia-related needs from Baseline to 18 months (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01283750, which also lists 6 linked publications.

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 6 Nov 2018.

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