NCT02482623

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
2.1 years until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

November 2, 2022

Status Verified

September 1, 2018

Enrollment Period

7 months

First QC Date

June 23, 2015

Last Update Submit

October 31, 2022

Conditions

Keywords

Dementianeuropsychiatric symptomsimplementation sciencedepressionpain

Outcome Measures

Primary Outcomes (2)

  • Person With Dementia Quality of Life

    Quality of Life in Alzheimer's Disease survey instrument

    60 Days

  • Caregiver Quality of Life

    Caregiver Targeted Quality of Life survey instrument

    60 Days

Secondary Outcomes (6)

  • Person with Dementia Pain

    60 days

  • Person with Dementia Neuropsychiatric Symptom Burden

    60 days

  • Caregiver Depression

    60 days

  • Person with Dementia ER Visits

    30, 60 days

  • Person with Dementia Hospital Admissions

    30, 60 days

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

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.

Also known as: DSM-H
Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The New Jewish Home

New York, New York, 10001, United States

Location

New York University College of Nursing

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

DementiaDepressionPain

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavioral SymptomsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Abraham A Brody, RN, PhD, GNP-BC

    Assistant Professor

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2015

First Posted

June 26, 2015

Study Start

August 1, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

November 2, 2022

Record last verified: 2018-09

Locations