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WithdrawnNCT02482623DSM-HUpdated Nov 2, 2022

The Dementia Symptom Management at Home Program

An interventional study of Dementia Symptom Management at Home Program in Dementia, sponsored by New York University. Withdrawn at 2 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-11-02.

Sponsored by New York University · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
Loss of study site
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

Persons with dementia and their caregivers are often cared for in the community through home healthcare (HHC). While these patients and their caregivers need significant help and often have difficulty maintaining their quality of life, home healthcare clinicians are often unprepared to care for this population. This study will therefore examine the ability of an integrated, multi-pronged evidence-based practice intervention for home healthcare registered nurses, occupational therapists and physical therapists, the DSM-H, to improve the quality of care and quality of life for persons with dementia and their family caregiver. The investigators will enroll persons with dementia and their family caregiver upon admission to the HHC agency and examine their quality of life over 60 days following admission, comparing those who receive the intervention to those who serve as controls.

Read the detailed description

The Dementia Symptom Management at Home (DSM-H) Program is an integrated bundled implementation science intervention to improve interprofessional care in home healthcare (HHC). It consists of training, assessment instruments, patient-caregiver centered care plans and workflow changes. The investigators will perform a cluster randomized controlled clinical trial at a single, urban, non-profit HHC agency, randomizing care teams to either be trained in performing the intervention or serve as controls. The aims of this program are to examine the efficacy of this program to:

Aim 1: Measure the effects of DSM-H on pain, neuropsychiatric symptoms, and caregiver rated QOL in the person with dementia receiving HHC.

Aim 2: Assess the effects of DSM-H on QOL, burden and depression for the informal caregiver of persons with dementia receiving HHC.

Aim 3: Assess the effects of DSM-H on the number of emergency room visits and hospital admissions.

02

Conditions studied

  • Dementia

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Keywords

  • Dementia
  • neuropsychiatric symptoms
  • implementation science
  • depression
  • pain
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

Browse Dementia studies →

Lead sponsor

New York University is the lead sponsor of 120 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patient-caregiver dyad admitted to the HHC agency
  • Patients must be 65 or older and speak English and/or Spanish.
  • Patient must have an informal caregiver who is at least 18 years old and spends at least 8 hours per week with the patient.
  • Patients must score greater than 4 on the cognitive subscale of the Healthy Aging Brain Care Monitor signifying at least mild impairment

Exclusion criteria

Exclusion Criteria:

  • Patients with concomitant axis I disorders other than dementia, depression, adjustment disorders, sleep disorders.
  • Patients being seen only in the behavioral health unit without another skilled need.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Intervention

    Dyads in this arm will receive care provided by an interprofessional team trained through the DSM-H to provide patient/caregiver-centered dementia care through home healthcare.

    Behavioral: Dementia Symptom Management at Home Program

  • No intervention
    Control

    Dyads in this arm will receive usual care provided in the home healthcare setting.

Interventions

  • BehavioralDementia Symptom Management at Home Program

    The DSM-H is a multi-modal interprofessional intervention that includes: 1. intensive training of clinician mentors; 2. disseminated online training for Registered Nurses, Physical Therapists, Occupational Therapists; 3. implementation of evidence-based care plans, assessment instruments, and teaching handouts.

    Also known as: DSM-H

06

What researchers measure

Primary outcomes

  1. Person With Dementia Quality of Life

    Quality of Life in Alzheimer's Disease survey instrument

    Time frame: 60 Days

  2. Caregiver Quality of Life

    Caregiver Targeted Quality of Life survey instrument

    Time frame: 60 Days

Secondary outcomes

  1. Person with Dementia Pain

    Pain Assessment in Advanced Dementia or Brief Pain Inventory survey instrument

    Time frame: 60 days

  2. Person with Dementia Neuropsychiatric Symptom Burden

    Healthy Aging Brain Care Monitor survey instrument

    Time frame: 60 days

  3. Caregiver Depression

    Public Health Questionnaire-9 survey instrument

    Time frame: 60 days

  4. Person with Dementia ER Visits

    Resource Utilization Inventory survey instrument

    Time frame: 30, 60 days

  5. Person with Dementia Hospital Admissions

    Resource Utilization Inventory survey instrument

    Time frame: 30, 60 days

  6. Person with Dementia Functional Status

    Katz Activities of Daily Living and Lawton Instrumental Activities of Daily Living assessments

    Time frame: 60 days

07

Study locations

2 sites
  • The New Jewish Home
    New York, New York 10001, United States
  • New York University College of Nursing
    New York, New York 10010, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02482623
Lead sponsor
New York University
Collaborators
Visiting Nurse Service of New York
Responsible party
Sponsor
First posted
Jun 26, 2015
Start date
Aug 1, 2017
Primary completion
Mar 1, 2018
Completion
Mar 1, 2018
Last update
Nov 2, 2022

Study contacts

Abraham A Brody, RN, PhD, GNP-BC
principal investigator · Assistant Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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