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Clinical Trials/NCT03352791
NCT03352791
Terminated
N/A

A Cluster Randomized Controlled Trial (RCT) of the Dementia Symptom Management (DSM) at Home Program Hospice Edition

NYU Langone Health1 site in 1 country2 target enrollmentAugust 1, 2018
ConditionsDementia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dementia
Sponsor
NYU Langone Health
Enrollment
2
Locations
1
Primary Endpoint
Reduction in Behavioral and Psychological Symptoms of Dementia (BPSD) using Neuropsychiatric Inventory Questionnaire (NPI-Q):
Status
Terminated
Last Updated
6 years ago

Overview

Brief Summary

Alzheimer's Disease and Related Disorders (dementia) poses a significant challenge to our public health. While many persons with dementia are cared for by friends and family in the community with the assistance of home healthcare and hospice, most clinicians and agencies are ill prepared to care for this population and therefore have difficulty assisting patients and caregivers in maintaining quality of life leading to adverse patient outcomes, increased caregiver stress and burnout, and healthcare utilization. This study will utilize a cluster randomized controlled design with 6 care teams at a single study site to examine the ability of a multi-component evidence-based practice hospice care quality improvement program for registered nurses, social workers and chaplains to improve the quality of life and reduce healthcare utilization for persons with dementia and their informal caregiver.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
October 5, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • PWD over the age of 65
  • Admitted to MJHS hospice agency
  • The patient and family caregiver speak English and/or Spanish.
  • The informal caregiver is ≥18 years of age and spends at least 8 hours per week with the patient.
  • Patients who score ≥6 on the Quick Dementia Rating Scale (at least mild impairment).

Exclusion Criteria

  • Patients with a separate Axis 1 diagnosis other than forms of dementia, depression or anxiety.
  • PWD residing in assisted living facilities, nursing homes or board and care homes
  • PWD solely receiving infusion or home health aide services.

Outcomes

Primary Outcomes

Reduction in Behavioral and Psychological Symptoms of Dementia (BPSD) using Neuropsychiatric Inventory Questionnaire (NPI-Q):

Time Frame: Day 0 and Day 30

13-item tool that measures caregiver perception of BPSD presence and severity in PWD

Reduction in pain (PAINAD)

Time Frame: Day 0 and Day 30

pain assessment tool for use in persons with moderate to severe dementia who cannot provide reliable report, and will be used if the QDRS\>12

Study Sites (1)

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