Last reviewed · How we verify
Implementation of MIND at Home Into Primary Care for People Living With Dementia
NA trial testing MIND at Home in Dementia in 410 participants. Completed in 21 June 2024.
| Lead sponsor | American Medical Group Association |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 410 |
| Start date | 18 July 2022 |
| Primary completion | 5 April 2024 |
| Estimated completion | 21 June 2024 |
| Sites | 2 locations across United States |
American Medical Group Association
18 and older, any sex, with Dementia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Hospital transfers include hospitalizations, emergency department visits, and observation stays without admission.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Arm: PLWD | 0.97 | ± 7.94 |
| Data Validation Arm | 0.65 | ± 7.10 |
| Intervention Arm: PLWD CPs | NA | ± NA |
The secondary outcomes are number of total medications, number of anti-psychotics, acetylcholinesterase inhibitors, and memantine medications.
| Group | Value | 95% CI |
|---|---|---|
| Intervention Arm: PLWD | -0.43 | ± 3.99 |
| Data Validation Arm | 0.33 | ± 2.44 |
| Intervention Arm: PLWD CPs | NA | ± NA |
Time frame: Adverse event data were collected on each intervention patient from date of study enrollment through the conclusion of the 3-month study period.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Intervention Arm: PLWD | Data Validation Arm | Intervention Arm: PLWD CPs |
|---|---|---|---|---|
| Hospitalization | Injury, poisoning and procedural complications | — | — | — |
| Hospitalization | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Change in level of care | Nervous system disorders | — | — | — |
| ED Visit | Nervous system disorders | — | — | — |
| ED Visit | Injury, poisoning and procedural complications | — | — | — |
| ED Visit | Gastrointestinal disorders | — | — | — |
| Hospitalization | Cardiac disorders | — | — | — |
| Hospitalization | Investigations | — | — | — |
| Changed Level of Care | Social circumstances | — | — | — |
Most-reported serious reactions: Hospitalization, Hospitalization, Change in level of care, ED Visit, ED Visit, ED Visit, Hospitalization, Hospitalization.
Data from ClinicalTrials.gov NCT05406921 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05406921.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing