Dementia Management With Interactive Technology
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ClinicalTrials.gov Identifier: NCT03916588 |
Recruitment Status :
Enrolling by invitation
First Posted : April 16, 2019
Last Update Posted : March 10, 2020
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Sponsor:
Ochsner Health System
Information provided by (Responsible Party):
Ochsner Health System
Tracking Information | |||||
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First Submitted Date | April 10, 2019 | ||||
First Posted Date | April 16, 2019 | ||||
Last Update Posted Date | March 10, 2020 | ||||
Actual Study Start Date | August 16, 2018 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
Fitbit Charge HR activity and sleep data [ Time Frame: through study completion, an average of 1 year ] Average daily steps, minutes asleep
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Dementia Management With Interactive Technology | ||||
Official Title | Dementia Management With Interactive Technology | ||||
Brief Summary | 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. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Ecologic or Community Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Residents living on the memory care unit will have pre diagnosed advanced dementia or Alzheimer's disease. Subjects will have diminished or no capacity and will require a legally authorized representative. | ||||
Condition |
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Intervention | Behavioral: Individualized Care Plan
Medical, neuropsychological, and social assessment of patient's cognitive, behavioral, medical, and environmental needs with a focus on improving quality of life, reducing health care utilization, and improving staff/family caregiving burden along with a specific plan to address and monitor identified patient and staff/facility needs
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Study Groups/Cohorts | Memory Care Unit Residents
Residents on a locked memory care unit in southeastern Louisiana will be enrolled. Engaged family members and staff will also consent to provide qualitative information on the resident.
Intervention: Behavioral: Individualized Care Plan
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Enrolling by invitation | ||||
Estimated Enrollment |
56 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 31, 2020 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Not Provided | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03916588 | ||||
Other Study ID Numbers | 2018.078 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Ochsner Health System | ||||
Study Sponsor | Ochsner Health System | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Ochsner Health System | ||||
Verification Date | March 2020 |