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The Dementia Symptom Management at Home Program Hospice Edition

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03352791
Recruitment Status : Not yet recruiting
First Posted : November 24, 2017
Last Update Posted : December 6, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Dementia Behavioral: DSM-H Hospice Edition performance improvement program Behavioral: Usual Care

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Cluster Randomized Controlled Trial (RCT) of the Dementia Symptom Management (DSM) at Home Program Hospice Edition
Anticipated Study Start Date : January 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: DSM-H Hospice Edition
training, assigning of champions to serve as mentors and performance improvement leads, and workflow changes including caregiver education pamphlets, interdisciplinary care plans, treatment algorithms, and assessment instruments.
Behavioral: DSM-H Hospice Edition performance improvement program
Patients in the performance improvement group will receive care from a care team who has received the DSM-H Hospice Edition performance improvement program
Active Comparator: Control Arm
Usual Care
Behavioral: Usual Care
control will receive usual care from a care team who has not received the performance improvement program.

Outcome Measures

Primary Outcome Measures :
  1. 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

  2. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352791

Contact: Tessa Manwaring Jones (917) 951 -5588 tessajonesis@gmail.com

Sponsors and Collaborators
New York University School of Medicine
Principal Investigator: Abraham Brody, MD New York University School of Medicine
More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03352791     History of Changes
Other Study ID Numbers: 17-01080
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders