Clinical trial NCT03255967: Dementia Symptom Management at Home Program
Official title: A Multisite Cluster RCT of the Dementia Symptom Management at Home Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 217
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Quality of Life-Alzheimer's Disease Score
timeFrame: Baseline, Day 60
measure: Change in Caregiver-Targeted Quality of Life Measure Score - IADL Scale
timeFrame: Baseline, Day 60
measure: Change in Caregiver-Targeted Quality of Life Measure Score - ADL Scale
timeFrame: Baseline, Day 60
measure: Change in Caregiver-Targeted Quality of Life Measure Score - Role Limitations Scale
timeFrame: Baseline, Day 60
measure: Change in Caregiver-Targeted Quality of Life Measure Score - Personal Time Scale
timeFrame: Baseline, Day 60
measure: Change in Caregiver-Targeted Quality of Life Measure Score - Family Interaction Scale
timeFrame: Baseline, Day 60
measure: Change in Caregiver-Targeted Quality of Life Measure Score - Demands of Caregiving Scale
timeFrame: Baseline, Day 60
measure: Change in Caregiver-Targeted Quality of Life Measure Score - Worry Scale
timeFrame: Baseline, Day 60
measure: Change in Caregiver-Targeted Quality of Life Measure Score - Spirituality Scale
timeFrame: Baseline, Day 60
measure: Change in Caregiver-Targeted Quality of Life Measure Score - Benefits of Caregiving Scale
timeFrame: Baseline, Day 60
measure: Change in Caregiver-Targeted Quality of Life Measure Score - Caregiver Feelings Scale
timeFrame: Baseline, Day 60
measure: Number of Emergency Room (ER) Visits by Patients With Dementia (PWD) During Study Period
timeFrame: Up to Day 60
measure: Number of PWD Inpatient Admissions During Study Period
timeFrame: Up to Day 60
Secondary outcomes:
measure: Change in Pain Assessment In Advanced Dementia (PAINAD) Score
timeFrame: Baseline, Day 60
measure: Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score
timeFrame: Baseline, Day 60
measure: Number of PWD Who Use Antipsychotics During Study Period
timeFrame: Up to Day 60
measure: Number of PWD Who Use Analgesics During Study Period
timeFrame: Up to Day 60
measure: Number of PWD Outpatient Visits During Study Period
timeFrame: Up to Day 60
measure: Number of PWD Primary Care Provider Contacts During Study Period
timeFrame: Up to Day 60
measure: Change in Zarit Burden Inventory Score Among Caregivers
timeFrame: Baseline, Day 60
measure: Change in Public Health Questionnaire-9 (PHQ-9) Score Among Caregivers
timeFrame: Baseline, Day 60
measure: Change in Short-Form-12 - Physical Subscale (PCS-12) Score Among Caregivers
timeFrame: Baseline, Day 60
measure: Change in Short-Form-12 - Mental Health Subscale (MCS-12) Score Among Caregivers
timeFrame: Baseline, Day 60
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Abraham Brody, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.