The Dementia Symptom Management at Home Program (DSM-H)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02482623|
Recruitment Status : Recruiting
First Posted : June 26, 2015
Last Update Posted : September 13, 2017
|Condition or disease||Intervention/treatment|
|Dementia||Behavioral: Dementia Symptom Management at Home Program|
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)|
|Estimated Enrollment :||150 participants|
|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|
|Estimated Primary Completion Date :||March 1, 2018|
|Estimated Study Completion Date :||May 31, 2018|
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.
- Person With Dementia Quality of Life [ Time Frame: 60 Days ]Quality of Life in Alzheimer's Disease survey instrument
- Caregiver Quality of Life [ Time Frame: 60 Days ]Caregiver Targeted Quality of Life survey instrument
- Person with Dementia Pain [ Time Frame: 60 days ]Pain Assessment in Advanced Dementia or Brief Pain Inventory survey instrument
- Person with Dementia Neuropsychiatric Symptom Burden [ Time Frame: 60 days ]Healthy Aging Brain Care Monitor survey instrument
- Caregiver Depression [ Time Frame: 60 days ]Public Health Questionnaire-9 survey instrument
- Person with Dementia ER Visits [ Time Frame: 30, 60 days ]Resource Utilization Inventory survey instrument
- Person with Dementia Hospital Admissions [ Time Frame: 30, 60 days ]Resource Utilization Inventory survey instrument
- Person with Dementia Functional Status [ Time Frame: 60 days ]Katz Activities of Daily Living and Lawton Instrumental Activities of Daily Living assessments
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
|Contact: Abraham A Brody, RN, PhD, GNP-BCfirstname.lastname@example.org|
|United States, New York|
|The New Jewish Home||Recruiting|
|New York, New York, United States, 10001|
|Contact: MaryLou Harren, RN 347-556-7855 email@example.com|
|New York University College of Nursing||Not yet recruiting|
|New York, New York, United States, 10010|
|Contact: Abraham Brody, RN, PhD, GNP-BC 212-992-7341 firstname.lastname@example.org|
|Sub-Investigator: Allison P Squires, PhD, RN|
|Sub-Investigator: James E Galvin, MD, MPH|
|Principal Investigator:||Abraham A Brody, RN, PhD, GNP-BC||Assistant Professor|