DSM-H: The Dementia Symptom Management at Home Program

Sponsor
New York University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02482623
Collaborator
Visiting Nurse Service of New York (Other)
0
2
2
7
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dementia Symptom Management at Home Program
N/A

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 Design

Study Type:
Interventional
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 :
Aug 1, 2017
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Mar 1, 2018

Arms and Interventions

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 Names:
  • DSM-H
  • No Intervention: Control

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

    Outcome Measures

    Primary Outcome Measures

    1. Person With Dementia Quality of Life [60 Days]

      Quality of Life in Alzheimer's Disease survey instrument

    2. Caregiver Quality of Life [60 Days]

      Caregiver Targeted Quality of Life survey instrument

    Secondary Outcome Measures

    1. Person with Dementia Pain [60 days]

      Pain Assessment in Advanced Dementia or Brief Pain Inventory survey instrument

    2. Person with Dementia Neuropsychiatric Symptom Burden [60 days]

      Healthy Aging Brain Care Monitor survey instrument

    3. Caregiver Depression [60 days]

      Public Health Questionnaire-9 survey instrument

    4. Person with Dementia ER Visits [30, 60 days]

      Resource Utilization Inventory survey instrument

    5. Person with Dementia Hospital Admissions [30, 60 days]

      Resource Utilization Inventory survey instrument

    6. Person with Dementia Functional Status [60 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    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:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The New Jewish Home New York New York United States 10001
    2 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abraham A Brody, Assistant Professor, New York University
    ClinicalTrials.gov Identifier:
    NCT02482623
    Other Study ID Numbers:
    • i14-01960
    First Posted:
    Jun 26, 2015
    Last Update Posted:
    Sep 14, 2018
    Last Verified:
    Sep 1, 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, Assistant Professor, New York University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 14, 2018