---
title: Dementia Symptom Management at Home Program
nct_id: NCT03255967
overall_status: COMPLETED
phase: NA
sponsor: NYU Langone Health
study_type: INTERVENTIONAL
primary_condition: Dementia
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03255967.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03255967"
ct_last_update_post_date: 2024-01-30
last_seen_at: "2026-05-12T06:31:57.832Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Dementia Symptom Management at Home Program

**Official Title:** A Multisite Cluster RCT of the Dementia Symptom Management at Home Program

**NCT ID:** [NCT03255967](https://clinicaltrials.gov/study/NCT03255967)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 217
- **Lead Sponsor:** NYU Langone Health
- **Conditions:** Dementia
- **Start Date:** 2018-08-16
- **Completion Date:** 2022-05-31
- **CT.gov Last Update:** 2024-01-30

## 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

- **Minimum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **QI program care** (EXPERIMENTAL) — 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
- **Control** (ACTIVE_COMPARATOR) — Receive usual care from a care team who has not received the performance improvement program

## Interventions

- **DSM-H** (BEHAVIORAL) — Multi-modal quality improvement program for improving the quality of care provided to person with dementia (PWD)-informal caregiver dyads through HHC
- **Standard of Care** (BEHAVIORAL) — Subjects receive care through usual home healthcare assignment process.

## Primary Outcomes

- **Change in Quality of Life-Alzheimer's Disease Score** _(time frame: Baseline, Day 60)_ — 13-item measurement of Alzheimer's disease patients' health-related quality of life (HRQOL) by proxy (caregiver) assessment. Each item is rated on a 4-point Likert scale ranging from 1 (poor) to 4 (excellent). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate greater HRQOL. An increase in scores indicates HRQOL increased during the observational period.
- **Change in Caregiver-Targeted Quality of Life Measure Score - IADL Scale** _(time frame: Baseline, Day 60)_ — The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the IADL scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to assistance with IADLs improved during the observational period.
- **Change in Caregiver-Targeted Quality of Life Measure Score - ADL Scale** _(time frame: Baseline, Day 60)_ — The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the ADL scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to assistance with ADLs improved during the observational period.
- **Change in Caregiver-Targeted Quality of Life Measure Score - Role Limitations Scale** _(time frame: Baseline, Day 60)_ — The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the role limitations scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to role limitation due to caregiving improved during the observational period.
- **Change in Caregiver-Targeted Quality of Life Measure Score - Personal Time Scale** _(time frame: Baseline, Day 60)_ — The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the personal time scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to personal care improved during the observational period.
- **Change in Caregiver-Targeted Quality of Life Measure Score - Family Interaction Scale** _(time frame: Baseline, Day 60)_ — The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the family interaction scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to family interaction improved during the observational period.
- **Change in Caregiver-Targeted Quality of Life Measure Score - Demands of Caregiving Scale** _(time frame: Baseline, Day 60)_ — The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the demands of caregiving scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to demands of caregiving improved during the observational period.
- **Change in Caregiver-Targeted Quality of Life Measure Score - Worry Scale** _(time frame: Baseline, Day 60)_ — The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the worry scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to worry improved during the observational period.
- **Change in Caregiver-Targeted Quality of Life Measure Score - Spirituality Scale** _(time frame: Baseline, Day 60)_ — The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the spirituality scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to spirituality improved during the observational period.
- **Change in Caregiver-Targeted Quality of Life Measure Score - Benefits of Caregiving Scale** _(time frame: Baseline, Day 60)_ — The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the benefits of caregiving scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to benefits of caregiving improved during the observational period.
- **Change in Caregiver-Targeted Quality of Life Measure Score - Caregiver Feelings Scale** _(time frame: Baseline, Day 60)_ — The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across the following scales: assistance with activities of daily living (ADLs), assistance with instrumental ADLs (IADLs), personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score for the caregiver feelings scale ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life with respect to caregiver feelings improved during the observational period.
- **Number of Emergency Room (ER) Visits by Patients With Dementia (PWD) During Study Period** _(time frame: Up to Day 60)_ — Measured through interviews with the informal caregiver using the Resource Utilization Inventory.
- **Number of PWD Inpatient Admissions During Study Period** _(time frame: Up to Day 60)_ — Measured through interviews with the informal caregiver using the Resource Utilization Inventory.

## Secondary Outcomes

- **Change in Pain Assessment In Advanced Dementia (PAINAD) Score** _(time frame: Baseline, Day 60)_
- **Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score** _(time frame: Baseline, Day 60)_
- **Number of PWD Who Use Antipsychotics During Study Period** _(time frame: Up to Day 60)_
- **Number of PWD Who Use Analgesics During Study Period** _(time frame: Up to Day 60)_
- **Number of PWD Outpatient Visits During Study Period** _(time frame: Up to Day 60)_
- **Number of PWD Primary Care Provider Contacts During Study Period** _(time frame: Up to Day 60)_
- **Change in Zarit Burden Inventory Score Among Caregivers** _(time frame: Baseline, Day 60)_
- **Change in Public Health Questionnaire-9 (PHQ-9) Score Among Caregivers** _(time frame: Baseline, Day 60)_
- **Change in Short-Form-12 - Physical Subscale (PCS-12) Score Among Caregivers** _(time frame: Baseline, Day 60)_
- **Change in Short-Form-12 - Mental Health Subscale (MCS-12) Score Among Caregivers** _(time frame: Baseline, Day 60)_

## Locations (1)

- New York University School of Medicine, New York, New York, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.new york university school of medicine|new york|new york|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03255967*  
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