Clinical trial NCT02482623: The Dementia Symptom Management at Home Program
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dementia
Keywords: Dementia
neuropsychiatric symptoms
implementation science
depression
pain
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: Visiting Nurse Service of New York
First posted: 2015-06-26
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Person With Dementia Quality of Life
timeFrame: 60 Days
measure: Caregiver Quality of Life
timeFrame: 60 Days
Secondary outcomes:
measure: Person with Dementia Pain
timeFrame: 60 days
measure: Person with Dementia Neuropsychiatric Symptom Burden
timeFrame: 60 days
measure: Caregiver Depression
timeFrame: 60 days
measure: Person with Dementia ER Visits
timeFrame: 30, 60 days
measure: Person with Dementia Hospital Admissions
timeFrame: 30, 60 days
measure: Person with Dementia Functional Status
timeFrame: 60 days
Other outcomes:
Locations:
city: New York
country: United States
facility: The New Jewish Home
state: New York
city: New York
country: United States
facility: New York University College of Nursing
state: New York
Study officials:
affiliation: Assistant Professor
name: Abraham A Brody, RN, PhD, GNP-BC
role: PRINCIPAL_INVESTIGATOR
References: