Trial record 12 of 16 for:    Recruiting, Not yet recruiting, Available Studies | "Home Care Services"

Dementia Symptom Management at Home Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03255967
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : September 14, 2018
Information provided by (Responsible Party):
New York University School of Medicine

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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 : May 21, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Quality of Life-Alzheimer's Disease [ Time Frame: 60 Days ]
    The investigators will evaluate patient health-related quality of life (HRQOL) by proxy (caregiver) assessment using the 15-item Health Utilities Index (HUI2), a generic health state classification system with preference-based utility weights derived from the general population. The HUI is one of the more widely used utility measures and has been used in previous studies of elderly with dementia and their caregivers.

  2. Change in Caregiver-Targeted Quality of Life Measure [ Time Frame: 60 Days ]
    The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia, incorporates non-health related issues as well as positive aspects of caregiving, and has demonstrated feasibility as a phone-based instrument in both English and Spanish. Eighty items are 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.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

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 identifier (NCT number): NCT03255967

Contact: Kimberly Convery 212 992 7341

United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Kimberly Convery    212-992-7341   
Principal Investigator: Abraham Brody, PhD         
Sponsors and Collaborators
New York University School of Medicine
Principal Investigator: Abraham Brody, MD New York University School of Medicine

Responsible Party: New York University School of Medicine Identifier: NCT03255967     History of Changes
Other Study ID Numbers: 17-00810
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders