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Dementia Symptom Management at Home Program

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ClinicalTrials.gov Identifier: NCT03255967
Recruitment Status : Completed
First Posted : August 21, 2017
Last Update Posted : December 7, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dementia Behavioral: DSM-H Behavioral: Standard of Care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Multisite Cluster RCT of the Dementia Symptom Management at Home Program
Actual Study Start Date : August 16, 2018
Actual Primary Completion Date : March 31, 2022
Actual Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: QI program care
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
Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
Active Comparator: Control
provide usual carereceive usual care from a care team who has not received the performance improvement program
 Behavioral: Standard of Care
Subjects receive care through usual home healthcare assignment process.


Outcome Measures
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Primary Outcome Measures :
  1. 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; higher scores indicate greater HRQOL. An increase in scores indicates HRQOL increased during the observational period.

  2. Change in Caregiver-Targeted Quality of Life Measure Score [ 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 10 scales: assistance with ADLs, assistance with 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 ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life improved over the observational period.

  3. Number of 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.

  4. 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 Outcome Measures :
  1. Change in Pain Assessment In Advanced Dementia (PAINAD) Score [ Time Frame: Baseline, Day 60 ]
    5-item assessment of pain in individuals with advanced dementia. Items are ranked on a 3-point Likert scale from 0 to 2. The total score is the sum of responses and ranges from 0 (no pain) to 10 (severe pain). An increase in scores indicates pain increased during the observational period.

  2. Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score [ Time Frame: Baseline, Day 60 ]
    13-item tool that measures caregiver perceptions of Behavioral and Psychological Symptoms of Dementia (BPSD). For each item, The severity of the reported symptoms is assessed on a 3-point scale. The total severity score ranges from 0 to 36 with higher scores representing worse severity. An increase in score indicates severity of BPSD increased during the observational period.

  3. Number of PWD who Use Antipsychotics during Study Period [ Time Frame: Up to Day 60 ]
    Measured via patient medication record.

  4. Number of PWD who Use Analgesics during Study Period [ Time Frame: Up to Day 60 ]
    Measured via patient medication record.

  5. Number of PWD Outpatient Visits during Study Period [ Time Frame: Up to Day 60 ]
  6. Number of PWD Primary Care Provider Contacts during Study Period [ Time Frame: Up to Day 60 ]
  7. Change in Zarit Burden Inventory Score among Caregivers [ Time Frame: Baseline, Day 60 ]
    22-item self-assessment of burden experienced by caregivers. Items are ranked on a Likert scale from 0 (never) to 4 (nearly always). The total score is the sum of responses and ranges from 0 to 88, where: 0 - 21 = little or no burden; 21 - 40 = mild to moderate burden; 41 - 60 = moderate to severe burden; and 61 - 88 = severe burden. An increase in scores indicates burden increased during the observational period.

  8. Change in Public Health Questionnaire-9 (PHQ-9) Score among Caregivers [ Time Frame: Baseline, Day 60 ]
    9-item measurement of depression in which caregivers indicate how often they have been bothered by specific problems over the previous 2 weeks. Items are ranked on 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater severity of depression.

  9. Change in Short-Form-12 (SF-12) Score among Caregivers [ Time Frame: Baseline, Day 60 ]
    12-item tool that measures functional health and well-being. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255967


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Abraham Brody, MD NYU Langone Health
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03255967    
Other Study ID Numbers: 17-00810
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: December 7, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders