DementiaNCT02945085
3D Team Care for Cognitively Vulnerable Older Adults
A study testing Home Based Care Team and Telephone Based Care Team in people with Dementia and Depression, run by UConn Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Depression, Delirium
- What is being tested?
- Home Based Care Team and Telephone Based Care Team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 506 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2017to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UConn Center on Aging
Farmington, Connecticut, 06030-5215
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). 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.
Read the 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.
- Conditions
- Dementia, Depression, Delirium
- Being tested
- Home Based Care Team, Telephone Based Care Team
- Keywords
- older adults, family caregivers, Medicare Advantage beneficiaries
- Medical subject headings
- Dementia, Depression, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Based Care TeamOther
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 TeamOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Home Based Care Team | Experimental | Primarily in-home treatment provided by team led by nurse practitioner with geriatrics and geriatric psychiatry expertise. Receives: Other: Home Based Care Team |
| Telephone Based Care Team | Active comparator | Primarily telephone-based treatment provided by existing care management program offered by collaborating Medicare Advantage insurer. Receives: Other: Telephone Based Care Team |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Patient Health Questionnaire (PHQ9)
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.
Measured: 12 months
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.
Measured: 12 months
Family caregiver perceived well-being
Self-reported well-being among family caregivers who enroll in the study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start6 Mar 2017
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Connecticut
- Responsible party
- Principal investigator, Fortinsky, Richard, UConn Health
- Investigators
- Richard H Fortinsky, PhD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945085
- Sponsor's protocol ID
- 17-021-1
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2016
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33354755Fortinsky 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.
PubMed 32194252
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Team Care for Cognitively Vulnerable Older Adults
- ClinicalTrials.gov ID
- NCT02945085
- Acronym / sponsor ID
- 17-021-1
- Conditions
- Dementia, Depression, Delirium
- Keywords
- older adults, family caregivers, Medicare Advantage beneficiaries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Connecticut
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Based Care Team | Experimental | Other: Home Based Care TeamPrimarily in-home treatment provided by team led by nurse practitioner with geriatrics and geriatric psychiatry expertise. |
| Telephone Based Care Team | Active comparator | Other: Telephone Based Care TeamPrimarily telephone-based treatment provided by existing care management program offered by collaborating Medicare Advantage insurer. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Based Care TeamClinical 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. | Other | Home Based Care Team |
| Telephone Based Care TeamTelephone 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. | Other | Telephone Based Care Team |
Primary outcome
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.
3 secondary outcomes
Patient Health Questionnaire (PHQ9)
Time frame: 12 months
Caregiver Assessment of Function and Upset (CAFU)
Time frame: 12 months
Family caregiver perceived well-being
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Derived from this study: PubMed 33354755Levine 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.
- Derived from this study: PubMed 32194252Fortinsky 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.
- Individual participant dataSharing planned: No
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard H Fortinsky, PhD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Based Care Team and Telephone Based Care Team in people with Dementia and Depression, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion hospitalized or used emergency department without hospitalization (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02945085, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.