Dementia Symptom Management at Home Program

NYU Langone Health (Other)
Overall Status
Recruiting ID

Study Details

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, most home healthcare 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 therefore utilize a cluster randomized controlled design at 3 study sites to examine the ability of a multi-component evidence-based practice primary palliative care quality improvement program for home healthcare registered nurses, occupational therapists and physical therapists to improve the quality of life and reduce healthcare utilization for persons with dementia and their informal caregiver.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: DSM-H
  • Behavioral: Standard of Care

Study Design

Study Type:
Anticipated Enrollment :
300 participants
Intervention Model:
Parallel Assignment
Single (Participant)
Primary Purpose:
Official Title:
A Multisite Cluster RCT of the Dementia Symptom Management at Home Program
Actual Study Start Date :
Aug 16, 2018
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: QI program care

DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program

Behavioral: DSM-H
Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC

Active Comparator: Control

provide usual carereceive usual care from a care team who has not received the performance improvement program

Behavioral: Standard of Care
Subjects receive care through usual home healthcare assignment process.

Outcome Measures

Primary Outcome Measures

  1. Quality of Life-Alzheimer's Disease [60 Days]

    The investigators will evaluate patient health-related quality of life (HRQOL) by proxy (caregiver) assessment using the 15-item Health Utilities Index (HUI2), a generic health state classification system with preference-based utility weights derived from the general population. The HUI is one of the more widely used utility measures and has been used in previous studies of elderly with dementia and their caregivers.

  2. Change in Caregiver-Targeted Quality of Life Measure [60 Days]

    The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia, incorporates non-health related issues as well as positive aspects of caregiving, and has demonstrated feasibility as a phone-based instrument in both English and Spanish. Eighty items are distributed across 10 scales: assistance with ADLs, assistance with IADLs, personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving.

Eligibility Criteria


Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • PWD over the age of 65

  • Admitted to one of the three HHC agencies

  • 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 or board and care homes

  • PWD solely receiving infusion or home health aide services.

Contacts and Locations


Site City State Country Postal Code
1 New York University School of Medicine New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health


  • Principal Investigator: Abraham Brody, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
NYU Langone Health Identifier:
Other Study ID Numbers:
  • 17-00810
First Posted:
Aug 21, 2017
Last Update Posted:
Feb 14, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 14, 2022