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

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ClinicalTrials.gov Identifier: NCT02482623
Recruitment Status : Withdrawn (Loss of study site)
First Posted : June 26, 2015
Last Update Posted : September 14, 2018
Sponsor:
Collaborator:
Visiting Nurse Service of New York
Information provided by (Responsible Party):
Abraham A Brody, New York University

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.

Condition or disease Intervention/treatment Phase
Dementia Behavioral: Dementia Symptom Management at Home Program Not Applicable

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
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.
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine


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.
Behavioral: Dementia 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.
Other Name: DSM-H

No Intervention: Control
Dyads in this arm will receive usual care provided in the home healthcare setting.



Primary Outcome Measures :
  1. Person With Dementia Quality of Life [ Time Frame: 60 Days ]
    Quality of Life in Alzheimer's Disease survey instrument

  2. Caregiver Quality of Life [ Time Frame: 60 Days ]
    Caregiver Targeted Quality of Life survey instrument


Secondary Outcome Measures :
  1. Person with Dementia Pain [ Time Frame: 60 days ]
    Pain Assessment in Advanced Dementia or Brief Pain Inventory survey instrument

  2. Person with Dementia Neuropsychiatric Symptom Burden [ Time Frame: 60 days ]
    Healthy Aging Brain Care Monitor survey instrument

  3. Caregiver Depression [ Time Frame: 60 days ]
    Public Health Questionnaire-9 survey instrument

  4. Person with Dementia ER Visits [ Time Frame: 30, 60 days ]
    Resource Utilization Inventory survey instrument

  5. Person with Dementia Hospital Admissions [ Time Frame: 30, 60 days ]
    Resource Utilization Inventory survey instrument

  6. Person with Dementia Functional Status [ Time Frame: 60 days ]
    Katz Activities of Daily Living and Lawton Instrumental Activities of Daily Living assessments



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482623


Locations
United States, New York
The New Jewish Home
New York, New York, United States, 10001
New York University College of Nursing
New York, New York, United States, 10010
Sponsors and Collaborators
New York University
Visiting Nurse Service of New York
Investigators
Principal Investigator: Abraham A Brody, RN, PhD, GNP-BC Assistant Professor

Responsible Party: Abraham A Brody, Assistant Professor, New York University
ClinicalTrials.gov Identifier: NCT02482623     History of Changes
Other Study ID Numbers: i14-01960
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Abraham A Brody, New York University:
Dementia
neuropsychiatric symptoms
implementation science
depression
pain

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders