Dementia Symptom Management at Home Program

NCT ID: NCT03255967

Last Updated: 2024-01-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-16

Study Completion Date

2022-05-31

Brief Summary

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Alzheimer's Disease and Related Disorders (dementia) poses a significant challenge to our public health. While many persons with dementia are cared for by friends and family in the community with the assistance of home healthcare, most home healthcare clinicians and agencies are ill prepared to care for this population and therefore have difficulty assisting patients and caregivers in maintaining quality of life leading to adverse patient outcomes, increased caregiver stress and burnout, and healthcare utilization. This study will therefore utilize a cluster randomized controlled design at 3 study sites to examine the ability of a multi-component evidence-based practice primary palliative care quality improvement program for home healthcare registered nurses, occupational therapists and physical therapists to improve the quality of life and reduce healthcare utilization for persons with dementia and their informal caregiver.

Detailed Description

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Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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QI program care

DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program

Group Type EXPERIMENTAL

DSM-H

Intervention Type BEHAVIORAL

Multi-modal quality improvement program for improving the quality of care provided to person with dementia (PWD)-informal caregiver dyads through HHC

Control

Receive usual care from a care team who has not received the performance improvement program

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type BEHAVIORAL

Subjects receive care through usual home healthcare assignment process.

Interventions

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DSM-H

Multi-modal quality improvement program for improving the quality of care provided to person with dementia (PWD)-informal caregiver dyads through HHC

Intervention Type BEHAVIORAL

Standard of Care

Subjects receive care through usual home healthcare assignment process.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* PWD over the age of 65
* Admitted to one of the three HHC agencies
* The patient and family caregiver speak English and/or Spanish.
* The informal caregiver is ≥18 years of age and spends at least 8 hours per week with the patient.
* Patients who score ≥6 on the Quick Dementia Rating Scale (at least mild impairment).

Exclusion Criteria

* Patients with a separate Axis 1 diagnosis other than forms of dementia, depression or anxiety.
* PWD residing in assisted living facilities or board and care homes
* PWD solely receiving infusion or home health aide services.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abraham Brody, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

References

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Bristol AA, Convery KA, Sotelo V, Schneider CE, Lin SY, Fletcher J, Rupper R, Galvin JE, Brody AA. Protocol for an embedded pragmatic clinical trial to test the effectiveness of Aliviado Dementia Care in improving quality of life for persons living with dementia and their informal caregivers. Contemp Clin Trials. 2020 Jun;93:106005. doi: 10.1016/j.cct.2020.106005. Epub 2020 Apr 19.

Reference Type DERIVED
PMID: 32320844 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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17-00810

Identifier Type: -

Identifier Source: org_study_id

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