3D Team Care for Cognitively Vulnerable Older Adults
Primary Purpose
Dementia, Depression, Delirium
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Based Care Team
Telephone Based Care Team
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring older adults, family caregivers, Medicare Advantage beneficiaries
Eligibility 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
Sites / Locations
- UConn Center on AgingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Home Based Care Team
Telephone Based Care Team
Arm Description
Primarily in-home treatment provided by team led by nurse practitioner with geriatrics and geriatric psychiatry expertise.
Primarily telephone-based treatment provided by existing care management program offered by collaborating Medicare Advantage insurer.
Outcomes
Primary Outcome Measures
Proportion hospitalized or used emergency department without hospitalization
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
GRID Hamilton Rating Scale for Depression (GRID-HAMD), 17-item version.
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.
Caregiver Assessment of Function and Upset (CAFU)
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.
Family caregiver perceived well-being
Self-reported well-being among family caregivers who enroll in the study
Full Information
NCT ID
NCT02945085
First Posted
October 23, 2016
Last Updated
June 22, 2023
Sponsor
UConn Health
Collaborators
Patient-Centered Outcomes Research Institute, University of Connecticut
1. Study Identification
Unique Protocol Identification Number
NCT02945085
Brief Title
3D Team Care for Cognitively Vulnerable Older Adults
Official Title
3D Team Care for Cognitively Vulnerable Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
Patient-Centered Outcomes Research Institute, University of Connecticut
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Depression, Delirium
Keywords
older adults, family caregivers, Medicare Advantage beneficiaries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
576 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home Based Care Team
Arm Type
Experimental
Arm Description
Primarily in-home treatment provided by team led by nurse practitioner with geriatrics and geriatric psychiatry expertise.
Arm Title
Telephone Based Care Team
Arm Type
Active Comparator
Arm Description
Primarily telephone-based treatment provided by existing care management program offered by collaborating Medicare Advantage insurer.
Intervention Type
Other
Intervention Name(s)
Home Based Care Team
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Telephone Based Care Team
Intervention Description
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 Measure Information:
Title
Proportion hospitalized or used emergency department without hospitalization
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
GRID Hamilton Rating Scale for Depression (GRID-HAMD), 17-item version.
Description
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.
Time Frame
12 months
Title
Caregiver Assessment of Function and Upset (CAFU)
Description
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.
Time Frame
12 months
Title
Family caregiver perceived well-being
Description
Self-reported well-being among family caregivers who enroll in the study
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
World Health Organization (WHO) Disability Assessment Schedule, 12 item short form.
Description
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.
Time Frame
12 months
Title
Quality of Life-Alzheimer's Disease Scale (QOL-AD)
Description
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.
Time Frame
12 months
Title
Neuropsychiatric Inventory (NPI-C)
Description
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.
Time Frame
12 months
Title
Center for Epidemiologic Studies-Depression Scale (CES-D)
Description
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.
Time Frame
12 months
Title
Zarit Burden Scale, 12-item short form
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard H Fortinsky, PhD
Phone
860-679-8069
Email
fortinsky@uchc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Therence James, MPH
Phone
860-679-3812
Email
tjames@uchc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard H Fortinsky, PhD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Center on Aging
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-5215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Study Coordinator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33354755
Citation
Levine AMP, Emonds EE, Smith MA, Rickles NM, Kuchel GA, Steffens DC, Ohlheiser A, Fortinsky RH. Pharmacist Identification of Medication Therapy Problems Involving Cognition Among Older Adults Followed by a Home-Based Care Team. Drugs Aging. 2021 Feb;38(2):157-168. doi: 10.1007/s40266-020-00821-7. Epub 2020 Dec 23.
Results Reference
derived
PubMed Identifier
32194252
Citation
Fortinsky RH, Kuchel GA, Steffens DC, Grady J, Smith M, Robison JT. Clinical trial testing in-home multidisciplinary care management for older adults with cognitive vulnerability: Rationale and study design. Contemp Clin Trials. 2020 May;92:105992. doi: 10.1016/j.cct.2020.105992. Epub 2020 Mar 16.
Results Reference
derived
Learn more about this trial
3D Team Care for Cognitively Vulnerable Older Adults
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