- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02482623
The Dementia Symptom Management at Home Program (DSM-H)
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 Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10001
- The New Jewish Home
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New York, New York, United States, 10010
- New York University College of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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:
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No Intervention: Control
Dyads in this arm will receive usual care provided in the home healthcare setting.
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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
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60 Days
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Caregiver Quality of Life
Time Frame: 60 Days
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Caregiver Targeted Quality of Life survey instrument
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60 Days
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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
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Healthy Aging Brain Care Monitor survey instrument
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60 days
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Caregiver Depression
Time Frame: 60 days
|
Public Health Questionnaire-9 survey instrument
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60 days
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Person with Dementia ER Visits
Time Frame: 30, 60 days
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Resource Utilization Inventory survey instrument
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30, 60 days
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Person with Dementia Hospital Admissions
Time Frame: 30, 60 days
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Resource Utilization Inventory survey instrument
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30, 60 days
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Person with Dementia Functional Status
Time Frame: 60 days
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Katz Activities of Daily Living and Lawton Instrumental Activities of Daily Living assessments
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60 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Abraham A Brody, RN, PhD, GNP-BC, Assistant professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- i14-01960
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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