DementiaNCT05406921
Implementation of MIND at Home Into Primary Care for People Living With Dementia
A study testing MIND at Home in people with Dementia, run by American Medical Group Association at 2 sites in United States.
Trial summary
The number of people living with dementia (PLWD) is growing. PLWD are often cared for at home by an informal caregiver, but this care is often not sufficient, resulting in costly hospitalizations and other unnecessary and avoidable use of health services. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- MIND at Home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jul 2022to 21 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Community residing adults, ≥18 years
- People Living with Dementia (PLWD) defined by a diagnosis using algorithms based on CMS' Chronic Care Warehouse definition of Alzheimer's Disease, Related Dementias, Related Disorders, and Senile Dementia.11 This definition includes those who have an eligible diagnosis code on any eligible claim (i.e., inpatient, outpatient, skilled nursing facility (SNF), or home health visit or stay) in the past three years or a diagnosis on the patient problem list.
- Actively receiving primary care services at one of three primary care practices within two participating health care organizations selected as study sites.
- Have a reliable care partner who speaks English (or a language spoken by the Memory Care Coordinator).
- Willing to participate in all study home visits and related activities for the entire length of the study (3 months).
Who cannot join
- PLWD in crisis, e.g., show signs of abuse, neglect, extreme risk of danger to self or others), will be connected to appropriate services, but will be excluded from the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
McFarland Clinic
Ames, Iowa, 50010
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Implementation of MIND at Home Program in Primary Care for People Living With Dementia: A Pilot Study
The number of people living with dementia (PLWD) is growing. PLWD are often cared for at home by an informal caregiver, but this care is often not sufficient, resulting in costly hospitalizations and other unnecessary and avoidable use of health services. In addition, many PLWD are transferred to costly long-term care facilities despite their preference to live at home. One way to improve care for PLWD is to work with their primary care doctors to provide better quality of care at lower costs for their patients. To accomplish this, we propose to collaboratively implement the MIND at Home Dementia Care Coordination Program into primary care clinics. The program expands the skills of existing primary care staff to the level of Memory Care Coordinators (MCCs), who will work with a larger primary care team on combining the benefits of clinic-based services with home-based services that support PLWD, their families, and care partners.
Two health care organizations will enroll 150 people in the MIND at Home program for 3 months at a time. The program includes one home visit per month, a comprehensive needs assessment (which assesses medical, nonmedical, social, and environmental issues), the subsequent development and implementation of an individualized care plan, and unlimited contact with the MCC for the PLWD, their family, and care partner. The primary care team, including the MCC, will also have access to weekly virtual sessions focused on dementia and including short lectures and the discussion of specific case examples.
Read more
Rates of monthly hospitalizations among participants and emergency room (ER) visits and number of medications the PLWD takes every month will be collected from the health care organization. The hypothesis is that the rate of hospitalizations and ER visits will decrease, and the number of medications will also decrease. We hope to positively impact the quality and costs of care associated with caring for PLWD.
This pilot seeks to test the feasibility of implementing the MIND at Home program into primary care in a racially, ethnically, and geographically diverse population of PLWD to prepare for a larger study that will determine this program's effectiveness and spread it broadly into primary care clinics across the country.
From the perspectives of health systems and overall society, MIND at Home will reduce costs, improve primary care team satisfaction, and preserve the dignity and independence of PLWD by enabling them to age at home.
Read the detailed description
Integration of evidence-based collaborative care management models such as the MIND at Home Dementia Care Coordination Program within Primary Care (PC) aligns with the Centers for Medicare and Medicaid Services (CMS) initiatives to provide advanced PC services to an especially complex and costly patient group and aligns with AHRQ's team-based Collaborative Care Model. This project will embed and test the feasibility of a novel best practice-based approach, MIND at Home, within PC to enhance and elevate the role of existing PC staff to Memory Care Coordinators (MCCs), increase PC access to interdisciplinary collaborative care, and systematically combines the benefits of clinic-based services with home-based assessment to support family-centered care planning and implementation for PLWD and their care partners. Weekly virtual collaborative learning sessions that include geriatric psychiatry consultants augment the PC care team's work to support the development and mastery of dementia assessment and care management skills and confidence at the PC sites. Our overarching goal is to test and establish feasibility, acceptability, fidelity, and sample size/referral rate data for MIND at Home in PC to prepare for a future multi-site embedded pragmatic trial.
Aim 1: Evaluate the feasibility and validity of eligible PLWD identification, referral, and enrollment in a best practice-based dementia care coordination program (MIND at Home) at 3 primary care clinics. Algorithms based on CMS's Chronic Care Warehouse definition of Alzheimer's Disease (AD) or AD and Related Dementias (ADRD) will be deployed in each respective clinic's electronic health record (EHR) to identify eligible PLWD and standardized referral and enrollment protocols will be enacted. Referral, recruitment, patient acceptance, and attrition rates will be calculated to assess the feasibility of use of the algorithm and of the recruitment protocol. Health equity in recruitment and enrollment will be assessed by comparing demographics (race/ethnicity) of program enrollees with the background population e.g., clinic ADRD patient panel, and by comparing enrollment of rural vs. suburban PC sites.
Aim 2: Evaluate the feasibility, acceptability, and fidelity of implementing MIND at Home in 3 primary care clinics in 2 geographically and demographically diverse integrated health systems. Using a pragmatic trial design, 150 community-residing PC patients with an ADRD diagnosis will be enrolled, each for a 3-month period. Program enrollees will receive office- plus home-based dementia care assessment, individualized care planning, and implementation by an interdisciplinary PC-based team, supported by regular case-based learning sessions. Implementation will be assessed by collecting a standard set of delivery workflow process, clinical, and health care utilization metrics. The investigators will assess feasibility through referral, enrollment, and retention rates, number of MCC-dyad contacts, and clinic staff participation in weekly tele-collaboratives. Fidelity will be assessed through tracking the completion of intervention components and PC team self-evaluation. The investigators will survey clinic staff on perceived program acceptability, usefulness, and challenges/unintended consequences. Program implementation will be tailored to accommodate diverse dyads (PLWD + care partner), which will be closely monitored and tracked.
Aim 3: Evaluate the feasibility of ascertainment of patient-level outcomes over time using electronic health record (EHR) data. The primary outcome (hospital transfers including admissions, ER visits, and observation stays without admissions), and secondary outcomes (number of medications for enrolled patients) will be gathered using EHR data. Accuracy of ascertainment will be tested through chart review. All clinical outcomes will be collected as time-stamped events for each enrolled patient retrospectively for 3 months prior to enrollment, during enrollment (3 months), and 1-month post-enrollment (total observation=7 months). All outcomes will be assessed by race, ethnicity, and rurality of the PLWD.
Embedding a collaborative, best-practice-based approach such as MIND at Home into PC is a potentially powerful strategy to organize care, improve quality, reduce costs, and maximize the population-level benefit for PLWD. This proposal tests the feasibility of implementing MIND at Home into PC in a racially, ethnically, and geographically diverse PLWD population in order to prepare for a multisite embedded pragmatic clinical trial (ePCT) to evaluate effectiveness, and eventually support broader dissemination and uptake in PC.
- Conditions
- Dementia
- Being tested
- MIND at Home
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIND at HomeBehavioural
Maximizing Independence at Home-MIND at Home (MIND) is a comprehensive care coordination program born from geriatric psychiatry. This model takes an interdisciplinary, collaborative care approach to care by systematically assessing and addressing a wide range of dementia-care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm: PLWD | Experimental | 100 community-residing PC patients with an ADRD diagnosis will be enrolled and receive MIND coordination services for 3 months to test program implementation feasibility in PC practice settings. Receives: Behavioral: MIND at Home |
| Data Validation Arm | No intervention | An additional 100 PLWD will serve as a data validation arm to demonstrate the feasibility of collecting and validating data from large health systems. |
| Intervention Arm: PLWD CPs | Experimental | 100 Care Partners (CPs) of the 100 community-residing PC patients with an ADRD diagnosis will be enrolled and receive MIND coordination services for 3 months to test program implementation feasibility in PC practice settings. Receives: Behavioral: MIND at Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Hospital Transfers Pre/Post Intervention
Hospital transfers include hospitalizations, emergency department visits, and observation stays without admission.
Measured: Data will be collected monthly for the 3 months prior to enrollment, the 3 months during enrollment, and one month post enrollment.
Secondary outcomes (1)
Change in Number of Medications Pre/Post Intervention
The secondary outcomes are number of total medications, number of anti-psychotics, acetylcholinesterase inhibitors, and memantine medications.
Measured: Data will be collected monthly for the 3 months prior to enrollment, the 3 months during enrollment, and one month post enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start18 Jul 2022
- Primary completion5 Apr 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Medical Group Association
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Brown University, Johns Hopkins University, McFarland Clinic, Wake Forest University Health Sciences
- Responsible party
- Sponsor
- Investigators
- Elizabeth L Ciemins, PhD, Principal investigator, American Medical Group Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406921
- Sponsor's protocol ID
- FY21_Pilot1_Ciemins
- Other IDs
- 3U54AG063546-03
- Status last verified
- Jan 2025
- First submitted
- 1 Jun 2022
- Last updated
- 31 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olsen C, Pedersen I, Bergland A, Enders-Slegers MJ, Joranson N, Calogiuri G, Ihlebaek C. Differences in quality of life in home-dwelling persons and nursing home residents with dementia - a cross-sectional study. BMC Geriatr. 2016 Jul 11;16:137. doi: 10.1186/s12877-016-0312-4.
PubMed 27400744Samus 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 24502822Tanner JA, Black BS, Johnston D, Hess E, Leoutsakos JM, Gitlin LN, Rabins PV, Lyketsos CG, Samus QM. A randomized controlled trial of a community-based dementia care coordination intervention: effects of MIND at Home on caregiver outcomes. Am J Geriatr Psychiatry. 2015 Apr;23(4):391-402. doi: 10.1016/j.jagp.2014.08.002. Epub 2014 Aug 13.
PubMed 25260557Samus QM, Black BS, Reuland M, Leoutsakos JS, Pizzi L, Frick KD, Roth DL, Gitlin LN, Lyketsos CG, Johnston D. MIND at Home-Streamlined: Study protocol for a randomized trial of home-based care coordination for persons with dementia and their caregivers. Contemp Clin Trials. 2018 Aug;71:103-112. doi: 10.1016/j.cct.2018.05.009. Epub 2018 May 18.
PubMed 29783091Samus QM, Davis K, Willink A, Black BS, Reuland M, Leoutsakos J, Roth DL, Wolff J, Gitlin LN, Lyketsos CG, Johnston D. Comprehensive home-based care coordination for vulnerable elders with dementia: Maximizing Independence at Home-Plus-Study protocol. Int J Care Coord. 2017 Dec;20(4):123-134. doi: 10.1177/2053434517744071. Epub 2017 Dec 14.
PubMed 29607051Black BS, Johnston D, Leoutsakos J, Reuland M, Kelly J, Amjad H, Davis K, Willink A, Sloan D, Lyketsos C, Samus QM. Unmet needs in community-living persons with dementia are common, often non-medical and related to patient and caregiver characteristics. Int Psychogeriatr. 2019 Nov;31(11):1643-1654. doi: 10.1017/S1041610218002296. Epub 2019 Feb 4.
PubMed 30714564Black 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 24479141Hughes TB, Black BS, Albert M, Gitlin LN, Johnson DM, Lyketsos CG, Samus QM. Correlates of objective and subjective measures of caregiver burden among dementia caregivers: influence of unmet patient and caregiver dementia-related care needs. Int Psychogeriatr. 2014 Nov;26(11):1875-83. doi: 10.1017/S1041610214001240. Epub 2014 Aug 8.
PubMed 25104063Willink A, Davis K, Johnston DM, Black B, Reuland M, Stockwell I, Amjad H, Lyketsos CG, Samus QM. Cost-Effective Care Coordination for People With Dementia at Home. Innov Aging. 2020 Jan 1;4(2):igz051. doi: 10.1093/geroni/igz051. eCollection 2020.
PubMed 31911954Amjad H, Roth DL, Samus QM, Yasar S, Wolff JL. Potentially Unsafe Activities and Living Conditions of Older Adults with Dementia. J Am Geriatr Soc. 2016 Jun;64(6):1223-32. doi: 10.1111/jgs.14164. Epub 2016 Jun 2.
PubMed 27253366Taylor DH Jr, Fillenbaum GG, Ezell ME. The accuracy of medicare claims data in identifying Alzheimer's disease. J Clin Epidemiol. 2002 Sep;55(9):929-37. doi: 10.1016/s0895-4356(02)00452-3.
PubMed 12393082
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of MIND at Home Program in Primary Care for People Living With Dementia: A Pilot Study
- ClinicalTrials.gov ID
- NCT05406921
- Acronym / sponsor ID
- FY21_Pilot1_Ciemins
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- American Medical Group AssociationUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Brown University, Johns Hopkins University, McFarland Clinic, Wake Forest University Health Sciences
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Posted 31 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The number of people living with dementia (PLWD) is growing. PLWD are often cared for at home by an informal caregiver, but this care is often not sufficient, resulting in costly hospitalizations and other unnecessary and avoidable use of health services. In addition, many PLWD are transferred to costly long-term care facilities despite their preference to live at home. One way to improve care for PLWD is to work with their primary care doctors to provide better quality of care at lower costs for their patients. To accomplish this, we propose to collaboratively implement the MIND at Home Dementia Care Coordination Program into primary care clinics. The program expands the skills of existing primary care staff to the level of Memory Care Coordinators (MCCs), who will work with a larger primary care team on combining the benefits of clinic-based services with home-based services that support PLWD, their families, and care partners.
Two health care organizations will enroll 150 people in the MIND at Home program for 3 months at a time. The program includes one home visit per month, a comprehensive needs assessment (which assesses medical, nonmedical, social, and environmental issues), the subsequent development and implementation of an individualized care plan, and unlimited contact with the MCC for the PLWD, their family, and care partner. The primary care team, including the MCC, will also have access to weekly virtual sessions focused on dementia and including short lectures and the discussion of specific case examples.
Rates of monthly hospitalizations among participants and emergency room (ER) visits and number of medications the PLWD takes every month will be collected from the health care organization. The hypothesis is that the rate of hospitalizations and ER visits will decrease, and the number of medications will also decrease. We hope to positively impact the quality and costs of care associated with caring for PLWD.
This pilot seeks to test the feasibility of implementing the MIND at Home program into primary care in a racially, ethnically, and geographically diverse population of PLWD to prepare for a larger study that will determine this program's effectiveness and spread it broadly into primary care clinics across the country.
From the perspectives of health systems and overall society, MIND at Home will reduce costs, improve primary care team satisfaction, and preserve the dignity and independence of PLWD by enabling them to age at home.
Detailed description
Integration of evidence-based collaborative care management models such as the MIND at Home Dementia Care Coordination Program within Primary Care (PC) aligns with the Centers for Medicare and Medicaid Services (CMS) initiatives to provide advanced PC services to an especially complex and costly patient group and aligns with AHRQ's team-based Collaborative Care Model. This project will embed and test the feasibility of a novel best practice-based approach, MIND at Home, within PC to enhance and elevate the role of existing PC staff to Memory Care Coordinators (MCCs), increase PC access to interdisciplinary collaborative care, and systematically combines the benefits of clinic-based services with home-based assessment to support family-centered care planning and implementation for PLWD and their care partners. Weekly virtual collaborative learning sessions that include geriatric psychiatry consultants augment the PC care team's work to support the development and mastery of dementia assessment and care management skills and confidence at the PC sites. Our overarching goal is to test and establish feasibility, acceptability, fidelity, and sample size/referral rate data for MIND at Home in PC to prepare for a future multi-site embedded pragmatic trial.
Aim 1: Evaluate the feasibility and validity of eligible PLWD identification, referral, and enrollment in a best practice-based dementia care coordination program (MIND at Home) at 3 primary care clinics. Algorithms based on CMS's Chronic Care Warehouse definition of Alzheimer's Disease (AD) or AD and Related Dementias (ADRD) will be deployed in each respective clinic's electronic health record (EHR) to identify eligible PLWD and standardized referral and enrollment protocols will be enacted. Referral, recruitment, patient acceptance, and attrition rates will be calculated to assess the feasibility of use of the algorithm and of the recruitment protocol. Health equity in recruitment and enrollment will be assessed by comparing demographics (race/ethnicity) of program enrollees with the background population e.g., clinic ADRD patient panel, and by comparing enrollment of rural vs. suburban PC sites.
Aim 2: Evaluate the feasibility, acceptability, and fidelity of implementing MIND at Home in 3 primary care clinics in 2 geographically and demographically diverse integrated health systems. Using a pragmatic trial design, 150 community-residing PC patients with an ADRD diagnosis will be enrolled, each for a 3-month period. Program enrollees will receive office- plus home-based dementia care assessment, individualized care planning, and implementation by an interdisciplinary PC-based team, supported by regular case-based learning sessions. Implementation will be assessed by collecting a standard set of delivery workflow process, clinical, and health care utilization metrics. The investigators will assess feasibility through referral, enrollment, and retention rates, number of MCC-dyad contacts, and clinic staff participation in weekly tele-collaboratives. Fidelity will be assessed through tracking the completion of intervention components and PC team self-evaluation. The investigators will survey clinic staff on perceived program acceptability, usefulness, and challenges/unintended consequences. Program implementation will be tailored to accommodate diverse dyads (PLWD + care partner), which will be closely monitored and tracked.
Aim 3: Evaluate the feasibility of ascertainment of patient-level outcomes over time using electronic health record (EHR) data. The primary outcome (hospital transfers including admissions, ER visits, and observation stays without admissions), and secondary outcomes (number of medications for enrolled patients) will be gathered using EHR data. Accuracy of ascertainment will be tested through chart review. All clinical outcomes will be collected as time-stamped events for each enrolled patient retrospectively for 3 months prior to enrollment, during enrollment (3 months), and 1-month post-enrollment (total observation=7 months). All outcomes will be assessed by race, ethnicity, and rurality of the PLWD.
Embedding a collaborative, best-practice-based approach such as MIND at Home into PC is a potentially powerful strategy to organize care, improve quality, reduce costs, and maximize the population-level benefit for PLWD. This proposal tests the feasibility of implementing MIND at Home into PC in a racially, ethnically, and geographically diverse PLWD population in order to prepare for a multisite embedded pragmatic clinical trial (ePCT) to evaluate effectiveness, and eventually support broader dissemination and uptake in PC.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm: PLWD | Experimental | Behavioral: MIND at Home100 community-residing PC patients with an ADRD diagnosis will be enrolled and receive MIND coordination services for 3 months to test program implementation feasibility in PC practice settings. |
| Data Validation Arm | No intervention | –An additional 100 PLWD will serve as a data validation arm to demonstrate the feasibility of collecting and validating data from large health systems. |
| Intervention Arm: PLWD CPs | Experimental | Behavioral: MIND at Home100 Care Partners (CPs) of the 100 community-residing PC patients with an ADRD diagnosis will be enrolled and receive MIND coordination services for 3 months to test program implementation feasibility in PC practice settings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Community residing adults, ≥18 years
- People Living with Dementia (PLWD) defined by a diagnosis using algorithms based on CMS' Chronic Care Warehouse definition of Alzheimer's Disease, Related Dementias, Related Disorders, and Senile Dementia.11 This definition includes those who have an eligible diagnosis code on any eligible claim (i.e., inpatient, outpatient, skilled nursing facility (SNF), or home health visit or stay) in the past three years or a diagnosis on the patient problem list.
- Actively receiving primary care services at one of three primary care practices within two participating health care organizations selected as study sites.
- Have a reliable care partner who speaks English (or a language spoken by the Memory Care Coordinator).
- Willing to participate in all study home visits and related activities for the entire length of the study (3 months).
Key exclusion criteria (1 listed)
- PLWD in crisis, e.g., show signs of abuse, neglect, extreme risk of danger to self or others), will be connected to appropriate services, but will be excluded from the study.
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 at HomeMaximizing Independence at Home-MIND at Home (MIND) is a comprehensive care coordination program born from geriatric psychiatry. This model takes an interdisciplinary, collaborative care approach to care by systematically assessing and addressing a wide range of dementia-care related needs of both PLWD and their care partners that place both at increased risk for poor outcomes. | Behavioural | Intervention Arm: PLWD, Intervention Arm: PLWD CPs |
Primary outcome
Change in Number of Hospital Transfers Pre/Post Intervention
Time frame: Data will be collected monthly for the 3 months prior to enrollment, the 3 months during enrollment, and one month post enrollment.
Hospital transfers include hospitalizations, emergency department visits, and observation stays without admission.
1 secondary outcome
Change in Number of Medications Pre/Post Intervention
Time frame: Data will be collected monthly for the 3 months prior to enrollment, the 3 months during enrollment, and one month post enrollment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27400744Olsen C, Pedersen I, Bergland A, Enders-Slegers MJ, Joranson N, Calogiuri G, Ihlebaek C. Differences in quality of life in home-dwelling persons and nursing home residents with dementia - a cross-sectional study. BMC Geriatr. 2016 Jul 11;16:137. doi: 10.1186/s12877-016-0312-4.
- Background: PubMed 24502822Samus 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.
- Background: PubMed 25260557Tanner JA, Black BS, Johnston D, Hess E, Leoutsakos JM, Gitlin LN, Rabins PV, Lyketsos CG, Samus QM. A randomized controlled trial of a community-based dementia care coordination intervention: effects of MIND at Home on caregiver outcomes. Am J Geriatr Psychiatry. 2015 Apr;23(4):391-402. doi: 10.1016/j.jagp.2014.08.002. Epub 2014 Aug 13.
- Background: PubMed 29783091Samus QM, Black BS, Reuland M, Leoutsakos JS, Pizzi L, Frick KD, Roth DL, Gitlin LN, Lyketsos CG, Johnston D. MIND at Home-Streamlined: Study protocol for a randomized trial of home-based care coordination for persons with dementia and their caregivers. Contemp Clin Trials. 2018 Aug;71:103-112. doi: 10.1016/j.cct.2018.05.009. Epub 2018 May 18.
- Background: PubMed 29607051Samus QM, Davis K, Willink A, Black BS, Reuland M, Leoutsakos J, Roth DL, Wolff J, Gitlin LN, Lyketsos CG, Johnston D. Comprehensive home-based care coordination for vulnerable elders with dementia: Maximizing Independence at Home-Plus-Study protocol. Int J Care Coord. 2017 Dec;20(4):123-134. doi: 10.1177/2053434517744071. Epub 2017 Dec 14.
- Background: PubMed 30714564Black BS, Johnston D, Leoutsakos J, Reuland M, Kelly J, Amjad H, Davis K, Willink A, Sloan D, Lyketsos C, Samus QM. Unmet needs in community-living persons with dementia are common, often non-medical and related to patient and caregiver characteristics. Int Psychogeriatr. 2019 Nov;31(11):1643-1654. doi: 10.1017/S1041610218002296. Epub 2019 Feb 4.
- Background: PubMed 24479141Black 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.
- Background: PubMed 25104063Hughes TB, Black BS, Albert M, Gitlin LN, Johnson DM, Lyketsos CG, Samus QM. Correlates of objective and subjective measures of caregiver burden among dementia caregivers: influence of unmet patient and caregiver dementia-related care needs. Int Psychogeriatr. 2014 Nov;26(11):1875-83. doi: 10.1017/S1041610214001240. Epub 2014 Aug 8.
- Background: PubMed 31911954Willink A, Davis K, Johnston DM, Black B, Reuland M, Stockwell I, Amjad H, Lyketsos CG, Samus QM. Cost-Effective Care Coordination for People With Dementia at Home. Innov Aging. 2020 Jan 1;4(2):igz051. doi: 10.1093/geroni/igz051. eCollection 2020.
- Background: PubMed 27253366Amjad H, Roth DL, Samus QM, Yasar S, Wolff JL. Potentially Unsafe Activities and Living Conditions of Older Adults with Dementia. J Am Geriatr Soc. 2016 Jun;64(6):1223-32. doi: 10.1111/jgs.14164. Epub 2016 Jun 2.
- Background: PubMed 12393082Taylor DH Jr, Fillenbaum GG, Ezell ME. The accuracy of medicare claims data in identifying Alzheimer's disease. J Clin Epidemiol. 2002 Sep;55(9):929-37. doi: 10.1016/s0895-4356(02)00452-3.
- Individual participant dataSharing planned: No
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Alzheimer Disease
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.
Elizabeth L Ciemins, PhD principal investigator
American Medical Group Association
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIND at Home in people with Dementia, run by American Medical Group Association at 2 sites 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 1 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 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 31 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Number of Hospital Transfers Pre/Post Intervention (time frame: Data will be collected monthly for the 3 months prior to enrollment, the 3 months during enrollment, and one month post enrollment.). 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 NCT05406921, which also lists 11 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 31 Jan 2025.