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Dementia Management With Interactive Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916588
Recruitment Status : Enrolling by invitation
First Posted : April 16, 2019
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Ochsner Health System

Tracking Information
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
 (submitted: April 12, 2019)
  • Mortality/Survival Rate [ Time Frame: through study completion, an average of 1 year ]
  • Quality of Life Scale (QoL) [ Time Frame: through study completion, an average of 1 year ]
    Neuropsychiatric/behavioral symptoms
  • Fall Incidence [ Time Frame: through study completion, an average of 1 year ]
    Neuropsychiatric/behavioral symptoms
  • Zarit Caregiver Burden [ Time Frame: through study completion, an average of 1 year ]
    Family burden
  • Patient Care Team Burden Scale (PCTB) [ Time Frame: through study completion, an average of 1 year ]
    staff caregiver burden
  • Healthcare Utilization [ Time Frame: through study completion, an average of 1 year ]
    Number of visits to hospital or clinic
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 12, 2019)
Fitbit Charge HR activity and sleep data [ Time Frame: through study completion, an average of 1 year ]
Average daily steps, minutes asleep
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
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
  • Dementia
  • Memory Disorders in Old Age
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
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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: April 12, 2019)
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:

  • 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
Sex/Gender
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ochsner Health System
Study Sponsor Ochsner Health System
Collaborators Not Provided
Investigators
Principal Investigator: R. John Sawyer, PhD Ochsner Health System
PRS Account Ochsner Health System
Verification Date March 2020