The Dementia Symptom Management at Home Program (DSM-H)
Primary Purpose
Dementia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dementia Symptom Management at Home Program
Sponsored by

About this trial
This is an interventional supportive care trial for Dementia focused on measuring Dementia, neuropsychiatric symptoms, implementation science, depression, pain
Eligibility Criteria
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.
Sites / Locations
- The New Jewish Home
- New York University College of Nursing
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
Dyads in this arm will receive usual care provided in the home healthcare setting.
Outcomes
Primary Outcome Measures
Person With Dementia Quality of Life
Quality of Life in Alzheimer's Disease survey instrument
Caregiver Quality of Life
Caregiver Targeted Quality of Life survey instrument
Secondary Outcome Measures
Person with Dementia Pain
Pain Assessment in Advanced Dementia or Brief Pain Inventory survey instrument
Person with Dementia Neuropsychiatric Symptom Burden
Healthy Aging Brain Care Monitor survey instrument
Caregiver Depression
Public Health Questionnaire-9 survey instrument
Person with Dementia ER Visits
Resource Utilization Inventory survey instrument
Person with Dementia Hospital Admissions
Resource Utilization Inventory survey instrument
Person with Dementia Functional Status
Katz Activities of Daily Living and Lawton Instrumental Activities of Daily Living assessments
Full Information
NCT ID
NCT02482623
First Posted
June 23, 2015
Last Updated
October 31, 2022
Sponsor
New York University
Collaborators
Visiting Nurse Service of New York
1. Study Identification
Unique Protocol Identification Number
NCT02482623
Brief Title
The Dementia Symptom Management at Home Program
Acronym
DSM-H
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Loss of study site
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
Collaborators
Visiting Nurse Service of New York
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Dementia, neuropsychiatric symptoms, implementation science, depression, pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Dyads in this arm will receive usual care provided in the home healthcare setting.
Intervention Type
Behavioral
Intervention Name(s)
Dementia Symptom Management at Home Program
Other Intervention Name(s)
DSM-H
Intervention Description
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.
Primary Outcome Measure Information:
Title
Person With Dementia Quality of Life
Description
Quality of Life in Alzheimer's Disease survey instrument
Time Frame
60 Days
Title
Caregiver Quality of Life
Description
Caregiver Targeted Quality of Life survey instrument
Time Frame
60 Days
Secondary Outcome Measure Information:
Title
Person with Dementia Pain
Description
Pain Assessment in Advanced Dementia or Brief Pain Inventory survey instrument
Time Frame
60 days
Title
Person with Dementia Neuropsychiatric Symptom Burden
Description
Healthy Aging Brain Care Monitor survey instrument
Time Frame
60 days
Title
Caregiver Depression
Description
Public Health Questionnaire-9 survey instrument
Time Frame
60 days
Title
Person with Dementia ER Visits
Description
Resource Utilization Inventory survey instrument
Time Frame
30, 60 days
Title
Person with Dementia Hospital Admissions
Description
Resource Utilization Inventory survey instrument
Time Frame
30, 60 days
Title
Person with Dementia Functional Status
Description
Katz Activities of Daily Living and Lawton Instrumental Activities of Daily Living assessments
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abraham A Brody, RN, PhD, GNP-BC
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
The New Jewish Home
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
New York University College of Nursing
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Dementia Symptom Management at Home Program
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