The Dementia Symptom Management at Home Program (DSM-H)

October 31, 2022 updated by: New York University

The Dementia Symptom Management at Home Program: A Bundled Interprofessional Intervention to Improve Dementia Patient-Caregiver Dyad Quality of Care and Quality of Life Through Home Healthcare.

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.

Study Overview

Status

Withdrawn

Conditions

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • DSM-H
No Intervention: Control
Dyads in this arm will receive usual care provided in the home healthcare setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Person With Dementia Quality of Life
Time Frame: 60 Days
Quality of Life in Alzheimer's Disease survey instrument
60 Days
Caregiver Quality of Life
Time Frame: 60 Days
Caregiver Targeted Quality of Life survey instrument
60 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Person with Dementia Pain
Time Frame: 60 days
Pain Assessment in Advanced Dementia or Brief Pain Inventory survey instrument
60 days
Person with Dementia Neuropsychiatric Symptom Burden
Time Frame: 60 days
Healthy Aging Brain Care Monitor survey instrument
60 days
Caregiver Depression
Time Frame: 60 days
Public Health Questionnaire-9 survey instrument
60 days
Person with Dementia ER Visits
Time Frame: 30, 60 days
Resource Utilization Inventory survey instrument
30, 60 days
Person with Dementia Hospital Admissions
Time Frame: 30, 60 days
Resource Utilization Inventory survey instrument
30, 60 days
Person with Dementia Functional Status
Time Frame: 60 days
Katz Activities of Daily Living and Lawton Instrumental Activities of Daily Living assessments
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Abraham A Brody, RN, PhD, GNP-BC, Assistant professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

June 23, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimate)

June 26, 2015

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

September 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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