An interventional study of Care Ecosystem in Dementia and Alzheimer Disease, sponsored by Mclean Hospital. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-05.
Sponsored by Mclean Hospital · Not applicable, Interventional, and Supportive care
There is growing need for to provide high quality care for persons living with dementia (PLWD) and provide support for care partners in the primary care setting. The Care Ecosystem model is a telephone-based dementia care program that provides standardized, proactive, personalized, and scalable support and education for care partners. The Care Ecosystem model has demonstrated an improvement in patient quality of life, reduced unnecessary healthcare expenditures, and a decrease in care partner burden and depression.
In this pilot the investigators will assess the feasibility of implementing and measuring outcomes of an adapted Care Ecosystem training model for primary care nurse managers serving a diverse panel of PLWD and their care partners in primary care practices participating in the Mass General Brigham healthcare system's Integrated Care Management Program in Boston, MA. The study team will leverage the Mass General Brigham electronic medical record to determine the feasibility of collecting the primary clinical outcome defined as emergency department visits among the PLWD cared for by the primary care practices. The investigative team will also assess the feasibility of implementation, number of contacts between nurse care managers and care partners, and documented advance care planning.
2,172 studies on the registry are indexed under Dementia; 541 are open to participants now.
This study's enrollment of 524 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Mclean Hospital is the lead sponsor of 181 studies on the registry; 32 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
- Permanent resident of long-term care or deceased at the start of the study
Nurse care managers will be randomized to either early or delayed adapted Care Ecosystem training. The Early Training arm will be the first group to receive training and the first to have the opportunity to use the training in a clinical setting. We anticipate that each nurse care manager will manage 10 PWLD and we anticipate a 50% response rate/data availability, yielding 75 patients per arm.
Behavioral: Care Ecosystem
The Delayed Training arm will be the second group of nurse care managers to receive training.
Behavioral: Care Ecosystem
The Care Ecosystem model uses a telephone-based intervention to support persons with dementia and their care partners, screening for common dementia-related problems and providing modular standardized support protocols and caregiver education. Specially trained health care navigators systematically identify needs and address health status, advance care planning, medication management and management of challenging behaviors. Health care navigators receive backup support from a nurse, social worker, dementia specialist, and pharmacist, and maintain close communication with the primary care provider of the persons with dementia. This Care Ecosystem model will be adapted to augment the dementia care provided by experienced Integrated Care Management Program nurse care managers engaged in the care of high-risk, high-cost patients in a large health system.
ED Visits Per Member Per Month 6 Months Post Intervention
Time frame: 6 months
Caregiver Distress (NPI-Q) 6 Months Post
Mean Neuropsychiatric Inventory Questionnaire (NPI-Q) distress score at 6-month follow-up survey. The NPI-Q distress scale assesses caregiver distress. Scores can range from 0 to 60 and higher scores indicate greater distress.
Time frame: 6 months
| Milestone | Intervention- PWD | Control- PWD | Intervention - NCM | Control- NCM |
|---|---|---|---|---|
| Started | 206 | 187 | 15 | 15 |
| Mailed caregiver survey | 143 | 113 | 0 | 0 |
| Completed baseline survey | 57 | 43 | 0 | 0 |
| Completed 6-month follow-up survey | 35 | 26 | 0 | 0 |
| Completed | 126 | 105 | 14 | 15 |
| Not completed | 80 | 82 | 1 | 0 |
| Withdrew: Death | 0 | 5 | 0 | 0 |
| Withdrew: No caregiver | 43 | 53 | 0 | 0 |
| Withdrew: Ineligible, snf | 2 | 2 | 0 | 0 |
| Withdrew: Ineligible, health | 3 | 4 | 0 | 0 |
| Withdrew: Ineligible, language | 0 | 1 | 0 | 0 |
| Withdrew: Ineligible, no longer in care management | 0 | 2 | 1 | 0 |
| Withdrew: No dementia | 13 | 3 | 0 | 0 |
| Withdrew: Missing identifier | 2 | 4 | 0 | 0 |
| Withdrew: Did not have at least 1 member month in pre and post period | 17 | 8 | 0 | 0 |
| Visits per member per month | Intervention | Control |
|---|---|---|
| ED Visits Per Member Per Month 6 Months Post Intervention | 0.056 ± 0.129 | 0.075 ± 0.144 |
Mean Neuropsychiatric Inventory Questionnaire (NPI-Q) distress score at 6-month follow-up survey. The NPI-Q distress scale assesses caregiver distress. Scores can range from 0 to 60 and higher scores indicate greater distress.
| Score on a scale | Intervention | Control |
|---|---|---|
| Caregiver Distress (NPI-Q) 6 Months Post | 10.86 ± 8.79 | 11.68 ± 8.60 |
Collected over 6 months post period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention- PWD | 21/126 (16.7%) | 0/126 (0%) | 0/126 (0%) |
| Control-PWD | 14/105 (13.3%) | 0/105 (0%) | 0/105 (0%) |
| Intervention- NCM | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Control- NCM | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
The analysis population for the primary outcome of Emergency Department visits was restricted to only include those PWD who had at least 1 member month during pre-intervention and post-intervention. The analysis population for the outcome of NPI-Q Distress among caregivers for persons with dementia was further restricted only to those who completed the baseline and 6-month follow-up surveys (Intervention, N=35; Control, N=28).
| Age, Categorical(Participants) | Intervention- PWD | Control- PWD | Intervention- NCM | Control- NCM | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 5 | 14 | 15 | 34 |
| >=65 years | 126 | 100 | 0 | 0 | 226 |
| Age, Continuous(years) | Intervention- PWD | Control- PWD | Intervention- NCM | Control- NCM | Total |
|---|---|---|---|---|---|
| Mean | 84.83 ± 8.17 | 82.88 ± 9.37 | — | — | 83.94 ± 8.77 |
| Sex: Female, Male(Participants) | Intervention- PWD | Control- PWD | Intervention- NCM | Control- NCM | Total |
|---|---|---|---|---|---|
| Female | 82 | 68 | 12 | 13 | 175 |
| Male | 44 | 37 | 2 | 2 | 85 |
| Ethnicity (NIH/OMB)(Participants) | Intervention- PWD | Control- PWD | Intervention- NCM | Control- NCM | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 19 | 6 | 0 | 0 | 25 |
| Not Hispanic or Latino | 103 | 97 | 0 | 0 | 200 |
| Unknown or Not Reported | 4 | 2 | 14 | 15 | 35 |
| Race (NIH/OMB)(Participants) | Intervention- PWD | Control- PWD | Intervention- NCM | Control- NCM | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 9 | 3 | 0 | 0 | 12 |
| White | 93 | 94 | 0 | 0 | 187 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 24 | 8 | 14 | 15 | 61 |
| Region of Enrollment(participants) | Intervention- PWD | Control- PWD | Intervention- NCM | Control- NCM | Total |
|---|---|---|---|---|---|
| United States | 126 | 105 | 14 | 15 | 231 |
| ED Visits Per Member Per Month(Visits per member per month) | Intervention- PWD | Control- PWD | Intervention- NCM | Control- NCM | Total |
|---|---|---|---|---|---|
| Mean | 0.060 ± 0.158 | 0.052 ± 0.080 | — | — | 0.057 ± 0.128 |
| NPI-Q Distress Score(Score on a scale) | Intervention- PWD | Control- PWD | Intervention- NCM | Control- NCM | Total |
|---|---|---|---|---|---|
| Mean | 11.17 ± 9.27 | 9.29 ± 6.41 | — | — | 10.33 ± 8.12 |
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