Dementia Management With Interactive Technology

• ClinicalTrials.gov Identifier: NCT03916588
• Recruitment Status: Enrolling by invitation
• First Posted: April 16, 2019
• Last Update Posted: March 10, 2020
• Sponsor: Ochsner Health System
• 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

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

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

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