The Dementia Symptom Management at Home Program

NCT ID: NCT02482623

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Dementia Symptom Management at Home Program

Intervention Type BEHAVIORAL

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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DSM-H

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Visiting Nurse Service of New York

OTHER

Sponsor Role collaborator

New York University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Abraham A Brody, RN, PhD, GNP-BC

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The New Jewish Home

New York, New York, United States

Site Status

New York University College of Nursing

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

i14-01960

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Care for America's Aging Study
NCT06021704 NOT_YET_RECRUITING NA
Telephone Support for Dementia Caregivers
NCT00735800 COMPLETED PHASE2