Dementia Clinical Trial
Official title:
Dementia Management With Interactive Technology
| NCT number | NCT03916588 |
| Other study ID # | 2018.078 |
| Secondary ID | |
| Status | Terminated |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 16, 2018 |
| Est. completion date | December 31, 2020 |
| Verified date | September 2021 |
| Source | Ochsner Health System |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
To investigate the efficacy of an individualized treatment plan delivered through remote technology along with enhanced staff training within a supervised memory unit on patient outcome, care quality, health care utilization/cost, and staff burden. Remote monitoring of activity data will also be explored.
| Status | Terminated |
| Enrollment | 89 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | July 31, 2020 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Residents living in a specific locked memory care unit in Southeastern Louisiana or - Family or staff identified as part of the care team of the resident |
| Country | Name | City | State |
|---|---|---|---|
| United States | Ochsner Health System | New Orleans | Louisiana |
| Lead Sponsor | Collaborator |
|---|---|
| Ochsner Health System |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mortality/Survival Rate | through study completion, an average of 1 year | ||
| Primary | Quality of Life Scale (QoL) | Neuropsychiatric/behavioral symptoms | through study completion, an average of 1 year | |
| Primary | Fall Incidence | Neuropsychiatric/behavioral symptoms | through study completion, an average of 1 year | |
| Primary | Zarit Caregiver Burden | Family burden | through study completion, an average of 1 year | |
| Primary | Patient Care Team Burden Scale (PCTB) | staff caregiver burden | through study completion, an average of 1 year | |
| Primary | Healthcare Utilization | Number of visits to hospital or clinic | through study completion, an average of 1 year | |
| Secondary | Fitbit Charge HR activity and sleep data | Average daily steps, minutes asleep | through study completion, an average of 1 year |
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