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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02482623
Other study ID # i14-01960
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date March 1, 2018

Study information

Verified date September 2018
Source New York University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 1, 2018
Est. primary completion date March 1, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States New York University College of Nursing New York New York
United States The New Jewish Home New York New York

Sponsors (2)

Lead Sponsor Collaborator
New York University Visiting Nurse Service of New York

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Person With Dementia Quality of Life Quality of Life in Alzheimer's Disease survey instrument 60 Days
Primary Caregiver Quality of Life Caregiver Targeted Quality of Life survey instrument 60 Days
Secondary Person with Dementia Pain Pain Assessment in Advanced Dementia or Brief Pain Inventory survey instrument 60 days
Secondary Person with Dementia Neuropsychiatric Symptom Burden Healthy Aging Brain Care Monitor survey instrument 60 days
Secondary Caregiver Depression Public Health Questionnaire-9 survey instrument 60 days
Secondary Person with Dementia ER Visits Resource Utilization Inventory survey instrument 30, 60 days
Secondary Person with Dementia Hospital Admissions Resource Utilization Inventory survey instrument 30, 60 days
Secondary Person with Dementia Functional Status Katz Activities of Daily Living and Lawton Instrumental Activities of Daily Living assessments 60 days
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