N/A N=430 Randomized Single-blind Treatment

Dementia Symptom Management at Home Program

Dementia

Bottom Line

View on ClinicalTrials.gov: NCT03255967 ↗

Enrolled (actual)

430

Serious AEs

15.6%

Results posted

Jan 2024

Primary outcome: Primary: Change in Quality of Life-Alzheimer's Disease Score — 12.32; 15.88 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: DSM-H (Behavioral); Standard of Care (Behavioral)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Quality of Life-Alzheimer's Disease Score	12.32; 15.88	—
PRIMARY Change in Caregiver-Targeted Quality of Life Measure Score - IADL Scale	12.32; 15.88	—
PRIMARY Change in Caregiver-Targeted Quality of Life Measure Score - ADL Scale	47.45; 44.94	—
PRIMARY Change in Caregiver-Targeted Quality of Life Measure Score - Role Limitations Scale	46.33; 46.56	—
PRIMARY Change in Caregiver-Targeted Quality of Life Measure Score - Personal Time Scale	38.71; 40.34	—
PRIMARY Change in Caregiver-Targeted Quality of Life Measure Score - Family Interaction Scale	53.27; 52.11	—
PRIMARY Change in Caregiver-Targeted Quality of Life Measure Score - Demands of Caregiving Scale	56.6; 56.22	—
PRIMARY Change in Caregiver-Targeted Quality of Life Measure Score - Worry Scale	51.25; 52.56	—
PRIMARY Change in Caregiver-Targeted Quality of Life Measure Score - Spirituality Scale	79.25; 67.75	—
PRIMARY Change in Caregiver-Targeted Quality of Life Measure Score - Benefits of Caregiving Scale	81.38; 79.34	—
PRIMARY Change in Caregiver-Targeted Quality of Life Measure Score - Caregiver Feelings Scale	72.53; 76.49	—
PRIMARY Number of Emergency Room (ER) Visits by Patients With Dementia (PWD) During Study Period	0.08; 0.08	—
PRIMARY Number of PWD Inpatient Admissions During Study Period	0.08; 0.13	—
SECONDARY Change in Pain Assessment In Advanced Dementia (PAINAD) Score	0.14; 0.05	—
SECONDARY Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score	8.45; 7.96	—
SECONDARY Number of PWD Who Use Antipsychotics During Study Period	20; 11	—
SECONDARY Number of PWD Who Use Analgesics During Study Period	45; 39	—
SECONDARY Number of PWD Outpatient Visits During Study Period	4.5; 3.16	—
SECONDARY Number of PWD Primary Care Provider Contacts During Study Period	0.64; 0.68	—
SECONDARY Change in Zarit Burden Inventory Score Among Caregivers	29.65; 26.14	—
SECONDARY Change in Public Health Questionnaire-9 (PHQ-9) Score Among Caregivers	4.8; 4.27	—
SECONDARY Change in Short-Form-12 - Physical Subscale (PCS-12) Score Among Caregivers	47.15; 47.13	—
SECONDARY Change in Short-Form-12 - Mental Health Subscale (MCS-12) Score Among Caregivers	46.63; 47.59	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03255967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.