Dementia Symptom Management at Home Program

NCT03255967 | Completed Results

• 1 other identifier: 17-00810
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (13)

• Change in Quality of Life-Alzheimer's Disease Score

  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.

  Baseline, Day 60

• Change in Caregiver-Targeted Quality of Life Measure Score - IADL Scale

  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.

  Baseline, Day 60

• Change in Caregiver-Targeted Quality of Life Measure Score - ADL Scale

  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.

  Baseline, Day 60

• Change in Caregiver-Targeted Quality of Life Measure Score - Role Limitations Scale

  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.

  Baseline, Day 60

• Change in Caregiver-Targeted Quality of Life Measure Score - Personal Time Scale

  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.

  Baseline, Day 60

• Change in Caregiver-Targeted Quality of Life Measure Score - Family Interaction Scale

  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.

  Baseline, Day 60

• Change in Caregiver-Targeted Quality of Life Measure Score - Demands of Caregiving Scale

  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.

  Baseline, Day 60

• Change in Caregiver-Targeted Quality of Life Measure Score - Worry Scale

  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.

  Baseline, Day 60

• Change in Caregiver-Targeted Quality of Life Measure Score - Spirituality Scale

  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.

  Baseline, Day 60

• Change in Caregiver-Targeted Quality of Life Measure Score - Benefits of Caregiving Scale

  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.

  Baseline, Day 60

• Change in Caregiver-Targeted Quality of Life Measure Score - Caregiver Feelings Scale

  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.

  Baseline, Day 60

• Number of Emergency Room (ER) Visits by Patients With Dementia (PWD) During Study Period

  Measured through interviews with the informal caregiver using the Resource Utilization Inventory.

  Up to Day 60

• Number of PWD Inpatient Admissions During Study Period

  Measured through interviews with the informal caregiver using the Resource Utilization Inventory.

  Up to Day 60

Secondary Outcomes (10)

• Change in Pain Assessment In Advanced Dementia (PAINAD) Score

  Baseline, Day 60

• Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score

  Baseline, Day 60

• Number of PWD Who Use Antipsychotics During Study Period

  Up to Day 60

• Number of PWD Who Use Analgesics During Study Period

  Up to Day 60

• Number of PWD Outpatient Visits During Study Period

  Up to Day 60

Study Arms (2)

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

Behavioral: DSM-H

Control

ACTIVE COMPARATOR

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

Behavioral: Standard of Care

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

QI program care

Standard of Care BEHAVIORAL

Subjects receive care through usual home healthcare assignment process.

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 32320844 DERIVED

MeSH Terms

Conditions

Dementia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Abraham Brody
• Organization: NYU Langone Health

Abraham.Brody@nyulangone.org

2129927341

Study Officials

• Abraham Brody, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 21, 2017
• Study Start: August 16, 2018
• Primary Completion: March 31, 2022
• Study Completion: May 31, 2022
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Locations

US (1)