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Completed

NCT Number: NCT02945085

3D Team Care for Cognitively Vulnerable Older Adults

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.

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Key information

Conditions

Dementia Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Confusion Delirium Depression Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UConn Center on Aging

Farmington, Connecticut, 06030-5215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home Based Care Team

Other

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.

Telephone Based Care Team

Other

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 outcomes

  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 outcomes

  1. Patient Health Questionnaire (PHQ9)

    Time frame: 12 months

    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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • Patient-Centered Outcomes Research Institute
  • University of Connecticut

Registry information

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2016
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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