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3D Team Care for Cognitively Vulnerable Older Adults

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ClinicalTrials.gov Identifier: NCT02945085
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : December 20, 2017
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
University of Connecticut
Information provided by (Responsible Party):
Fortinsky, Richard, UConn Health

Brief Summary:
This study addresses how to achieve better outcomes for cognitively vulnerable community-dwelling older adults and their families. Cognitive vulnerability means living with dementia, depression, and/or a recent episode of delirium (the 3Ds). The investigators will test the effectiveness of a team care model focused on the 3Ds (Home Based Care Team) guided by nurse practitioners with expertise in geriatrics and geriatric psychiatry. Specific aims are to determine Home Based Care Team effects on hospitalization or emergency department use, and other outcomes including depression, disability, and quality of life.

Condition or disease Intervention/treatment Phase
Dementia Depression Delirium Other: Home Based Care Team Other: Telephone Based Care Team Not Applicable

Detailed Description:
This study addresses how to achieve better outcomes for cognitively vulnerable community-dwelling older adults and their families. Cognitive vulnerability means living with dementia, depression, and/or a recent episode of delirium (the 3Ds). Cognitive vulnerability in older adults is often overlooked by primary care and hospital-based providers, and represents a marker for overall vulnerability or frailty often missed when disease-specific approaches are emphasized in the care for older adults. Such patients often cannot adequately self-manage their comorbidities. Many studies of older adults and their families have demonstrated the great burden of living with cognitive vulnerability. The investigators will test the effectiveness of a team care model focused on the 3Ds (Home Based Care Team) guided by nurse practitioners with geriatrics expertise. Other team member disciplines will include pharmacy, social work, occupational and physical therapy, nutrition, and community health worker. Long-term objectives are to determine whether this care model can become a widely available approach for improving healthcare systems for older adults with cognitive vulnerability and their families, while improving outcomes of importance to these patients and families. A project Steering Committee, including cognitively vulnerable patients and family caregivers, will provide extensive input into many aspects of the research process.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 3D Team Care for Cognitively Vulnerable Older Adults
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Home Based Care Team
Primarily in-home treatment provided by team led by nurse practitioner with geriatrics and geriatric psychiatry expertise.
Other: Home Based Care Team
Clinical team will conduct comprehensive clinical assessments focused on cognitive impairment and depression, conduct comprehensive medication review and reconciliation, offer Problem Solving Therapy, and offer brief occupational therapy, physical therapy, nutrition, and social support services.

Active Comparator: Telephone Based Care Team
Primarily telephone-based treatment provided by existing care management program offered by collaborating Medicare Advantage insurer.
Other: Telephone Based Care Team
Telephone contact will be made by nurses. Depending on level of need, follow up telephone and, in some cases, in home visits will be made by nurse or social worker from care management program.




Primary Outcome Measures :
  1. Proportion hospitalized or used emergency department without hospitalization [ Time Frame: 12 months ]
    Evidence of hospitalization or visit to emergency department without hospital admission will be based on data from the Medicare Advantage insurer's medical claims data warehouse.


Secondary Outcome Measures :
  1. GRID Hamilton Rating Scale for Depression (GRID-HAMD), 17-item version. [ Time Frame: 12 months ]
    This measure yields a score for each individual reflecting both frequency and intensity of all depression-related symptoms included in the structured interview. This outcome will be used for study participants with depression but not dementia or recent episode of delirium at baseline. Individual scores will be aggregated into group mean scores to compare intervention and active comparator groups on this outcome.

  2. Caregiver Assessment of Function and Upset (CAFU) [ Time Frame: 12 months ]
    This measure yields a score for each individual reflecting level of assistance required to conduct 7 self-care activities of daily living (ADLs) and 8 instrumental ADLs. In a structured interview format, family members report these items for their relatives with dementia and/or a recent history of delirium. Individual scores will be aggregated into group mean scores to compare intervention and active comparator groups on this outcome.

  3. Family caregiver perceived well-being [ Time Frame: 12 months ]
    Self-reported well-being among family caregivers who enroll in the study


Other Outcome Measures:
  1. World Health Organization (WHO) Disability Assessment Schedule, 12 item short form. [ Time Frame: 12 months ]
    This measure yields a score for each individual reflecting self-reported degree of difficulty performing physical activities in the home and community. Individual scores will be aggregated into group mean scores to compare intervention and active comparator groups on this outcome.

  2. Quality of Life-Alzheimer's Disease Scale (QOL-AD) [ Time Frame: 12 months ]
    This measure, used with individuals with dementia, yields a score for each individual reflecting self-ratings of poor, fair, good, or excellent on 13 items. Individual scores will be aggregated into group mean scores to compare intervention and active comparator groups on this outcome.

  3. Neuropsychiatric Inventory (NPI-C) [ Time Frame: 12 months ]
    This measure yields a single score that accounts for both frequency and severity of 14 neuropsychiatric symptoms. Family caregivers provide this information in a structured interview format. Individual scores will be aggregated into group mean scores to compare intervention and active comparator groups on this outcome.

  4. Center for Epidemiologic Studies-Depression Scale (CES-D) [ Time Frame: 12 months ]
    This measure will be used to determine severity of depression among family caregivers enrolled in the study.This measure yields a score for each individual reflecting frequency of 20 depression-related symptoms within the previous two weeks. Individual scores will be aggregated into group mean scores to compare intervention and active comparator groups on this outcome.

  5. Zarit Burden Scale, 12-item short form [ Time Frame: 12 months ]
    This measure will be used to determine severity of caregiving-related burden among family caregivers who enroll in the study.This measure yields a score for each individual based on self-reports by family caregivers on the degree of caregiving impact on emotional, physical, social, and financial aspects of life. Individual scores will be aggregated into group mean scores to compare intervention and active comparator groups on this outcome.



Information from the National Library of Medicine

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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:

  • Evidence of dementia, depression, and/or delirium, based on diagnostic codes found in medical claims data and based on screening at time of study screening.
  • Living in the community, including assisted living facility, at time of randomization
  • Plan to live in geographic area for 12 months
  • Speak or understand English
  • Willing to be randomly assigned to intervention or active comparator group

Exclusion Criteria:

  • Diagnosed schizophrenia or bipolar disorder
  • Bedbound and non-communicative
  • Life expectancy <12 months
  • Already enrolled in active comparator program
  • For individuals with dementia, family caregiver is unavailable or unwilling to enroll in study

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): NCT02945085


Contacts
Contact: Richard H Fortinsky, PhD 860-679-8069 fortinsky@uchc.edu
Contact: Kristen Annis, BA 860-679-3812 annis@uchc.edu

Locations
United States, Connecticut
UConn Center on Aging Recruiting
Farmington, Connecticut, United States, 06030-5215
Contact: Principal Investigator         
Contact: Study Coordinator         
Sponsors and Collaborators
UConn Health
Patient-Centered Outcomes Research Institute
University of Connecticut
Investigators
Principal Investigator: Richard H Fortinsky, PhD UConn Health

Responsible Party: Fortinsky, Richard, Professor, UConn Health
ClinicalTrials.gov Identifier: NCT02945085     History of Changes
Other Study ID Numbers: UConnHealth
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Fortinsky, Richard, UConn Health:
older adults
family caregivers
Medicare Advantage beneficiaries

Additional relevant MeSH terms:
Dementia
Delirium
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms