DementiaT2IP-DSNCT04631120
Team-based Technology-enabled Integrated Patient/Caregiver-focused Dementia Study
A study testing Integrated Dementia Practice Unit Design in people with Dementia, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Dementia patients experience memory and other cognitive function deterioration leading to loss of independent function. Care required for dementia is multifactorial, spanning cognitive, behavioral, emotional, and physical symptoms, and complicates aspects of daily living. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Integrated Dementia Practice Unit Design
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2021to Oct 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alzheimer's Disease or Vascular Dementia diagnosis provided by a study investigator
- 2 or 3 on the Clinical Dementia Rating Scale at time of enrollment
- Mini Mental Status Examination score of >10 or <25 administered at the time of enrollment
- Willingness and ability to provide patient or surrogate consent, and since caregiver cooperation will be an integral part of this study, an ability to provide caregiver consent to participate
Who cannot join
- Individuals with Mild Cognitive Impairment
- Institutionalized individuals (extended care facility, nursing home, group home, or similar institutional setting)
- Individuals who in the opinion of the investigator cannot be enrolled or followed due to geographic or other constraints
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Dementia patients experience memory and other cognitive function deterioration leading to loss of independent function. Care required for dementia is multifactorial, spanning cognitive, behavioral, emotional, and physical symptoms, and complicates aspects of daily living. This places tremendous strain on caregivers who, in turn, experience their own increased physical and mental health needs. The current care model focuses primarily on patient pharmacological management but misses the mark on caregiver focus and collaboration. Building on systematic reviews and existing evidence gaps in information and support for patient/caregiver dyads, dealing with behavioral symptoms, referrals to available community resources, and multidisciplinary team care with improved coordination and communication17, the study investigators propose a patient- and caregiver-targeted Integrated Dementia Practice Unit (IDPU) model of care. IDPU integrates disconnected care under a centralized specialty team, providing monitoring, education, individualized support, and proactive, ongoing collaboration and coaching using technology and home/virtual visits for maximal impact. Days alive at home (DAAH) best captures quality of life (QOL) for the index dementia patient, from the perspective of both the healthcare system and the caregiver, and degree of support for the caregiver and is often an outcome in assessing health delivery. The study investigators hypothesize IDPU will increase DAAH and improve patient-level (behavioral; depressive symptoms; chronic disease management) and caregiver-level (strain, depressive symptoms, social support) outcomes relative to an Educational+ model, merging a standard care design with additional education support for patients/caregivers and their Primary Care Providers (PCP). This study seeks to (a) improve and establish IDPU feasibility of the in the feasibility phase, (b) determine if IDPU is more effective than Education+ in increasing DAAH and patient- and caregiver-level outcomes, and (c) determine if benefits of IDPU are more or less pronounced in vulnerable subgroups in the full-scale study.
- Conditions
- Dementia
- Being tested
- Integrated Dementia Practice Unit Design, Standard of Care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Dementia Practice Unit DesignOther
- Dementia Central: monthly review of participant progress
- Dementia Mobile: monthly nurse/lay health educator visits for assessments, education and coaching
- Dementia Link: communication between Dementia Central and Dementia Mobile using the eTransX mHealth platform and HealthStream educational interface for care providers and the patient/caregiver dyad.
Standard of CareOther
Standard clinical practices of the physician and institution including an initial assessment, Zarit Burden Interview (ZBI) for caregiver, followed by provision of standard patient- and caregiver-centered educational material. Two phone sessions with a study nurse post-enrollment in months 1 and 6 to discuss the educational material and perform a needs assessment.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | The proposed arm will involve an initial assessment using the Clinical Dementia Rating (CDR) Scale and Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score for patients and Zarit Burden Interview (ZBI) for caregiver, followed by provision of standard educational material from the AA and Association for the Advancement of Retired Persons (AARP). Two phone sessions with a study nurse will occur post-enrollment in months 1 and 6 to discuss the educational material and perform a needs assessment; a summary of these and professional education on national evidence-based guidelines will be mailed to the patient's PCP of record. Education provided in this arm will be both patient- and caregiver-centered. Receives: Other: Standard of Care |
| Integrated Dementia Practice Unit Arm | Experimental | The integrated practice unit design is a coordinated, team-based, comprehensive, technology enabled, family focused care delivery design comprised of:
* Dementia Central: Nurses, physicians, psychologists, social workers, and other relevant healthcare providers that will meet monthly to review participants progress and issues. Telehealth visits would facilitate home care.
* Dementia Mobile: A nurse and lay health educator team will perform monthly visits, conduct assessments of subjects and provide education/coaching.
* Dementia Link: Technologies that facilitate communication between Dementia Central and Dementia Mobile and foster proactive collaboration/coaching for study subjects include an mHealth software that allows for real time intervention/communication between professional teams and dyads, combined with management of dyads for multiple parameters like health metrics, behavioral measures and stress management and a portal tailored to specific clinical needs. Receives: Other: Integrated Dementia Practice Unit Design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days Alive and At Home
Our primary outcome is days alive at home (DAAH) for an index dementia patient within 1-year of enrollment (defined as days NOT in a hospital, extended care facility, in-patient rehabilitation, hospice, or respite care facility since enrollment).
Measured: 12 months
Secondary outcomes (6)
Number of Neurobehavioral Changes
Neurobehavioral changes measured by Neuro-Psychiatric Inventory, Cornell Scale for Depression in Dementia
Measured: 24 months
Number of Health Resources Utilized
health resource contact-related outcomes (ER visits, office visits, urgent care or urgent office visits, respite care, hospitalizations for dementia-related illness)
Measured: 24 months
Percent of Participants Achieving Chronic Disease Control Based on Risk Factor Averages
Chronic disease control at target for blood pressure, LDL-C (if hyperlipidemic), HbgA1c (if diabetic), exercise levels, BMI, diet
Measured: 24 months
Perceived Social Support of Caregivers
Perceived social support using Multidimensional Scale of Perceived Social Support (Caregivers). 12-item measure of perceived adequacy of social support from three sources: family, friends, \& significant other; using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree).
Measured: 24 months
Assessment of Perceived Strain in Caregivers
Measurement of change in perceived strain in caregivers using Zarit Burden Interview. The ZBI uses a 4-point ordinal scale which describes the degree of burden being experienced from 0 = never to 4 = almost always. Maximum score is 88 and higher scores indicate more burden.
Measured: 24 months
Assessment of Caregiver Stress
Measurement of change in caregiver stress using NPI Caregiver Distress Scale. Caregiver distress associated with the symptom is rated on an anchored 0- to 5-point scale identical to that used in the NPI. 12 The total NPI-Q distress score represents the sum of individual symptom scores and ranges from 0 to 60.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study startOct 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2026 (estimated)
Why it stopped: The study was never started and the PI is retiring.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howard Kirshner, Vanderbilt University Medical Center
- Investigators
- Howard Kirshner, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631120
- Sponsor's protocol ID
- 55555
- Acronym
- T2IP-DS
- Status last verified
- Dec 2021
- First submitted
- 10 Nov 2020
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Team-based Technology-enabled Integrated Patient/Caregiver-focused Dementia Study
- ClinicalTrials.gov ID
- NCT04631120
- Acronym / sponsor ID
- T2IP-DS / 55555
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never started and the PI is retiring.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 17 Nov 2020 (actual)
- 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.
Dementia patients experience memory and other cognitive function deterioration leading to loss of independent function. Care required for dementia is multifactorial, spanning cognitive, behavioral, emotional, and physical symptoms, and complicates aspects of daily living. This places tremendous strain on caregivers who, in turn, experience their own increased physical and mental health needs. The current care model focuses primarily on patient pharmacological management but misses the mark on caregiver focus and collaboration. Building on systematic reviews and existing evidence gaps in information and support for patient/caregiver dyads, dealing with behavioral symptoms, referrals to available community resources, and multidisciplinary team care with improved coordination and communication17, the study investigators propose a patient- and caregiver-targeted Integrated Dementia Practice Unit (IDPU) model of care. IDPU integrates disconnected care under a centralized specialty team, providing monitoring, education, individualized support, and proactive, ongoing collaboration and coaching using technology and home/virtual visits for maximal impact. Days alive at home (DAAH) best captures quality of life (QOL) for the index dementia patient, from the perspective of both the healthcare system and the caregiver, and degree of support for the caregiver and is often an outcome in assessing health delivery. The study investigators hypothesize IDPU will increase DAAH and improve patient-level (behavioral; depressive symptoms; chronic disease management) and caregiver-level (strain, depressive symptoms, social support) outcomes relative to an Educational+ model, merging a standard care design with additional education support for patients/caregivers and their Primary Care Providers (PCP). This study seeks to (a) improve and establish IDPU feasibility of the in the feasibility phase, (b) determine if IDPU is more effective than Education+ in increasing DAAH and patient- and caregiver-level outcomes, and (c) determine if benefits of IDPU are more or less pronounced in vulnerable subgroups in the full-scale study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CareThe proposed arm will involve an initial assessment using the Clinical Dementia Rating (CDR) Scale and Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score for patients and Zarit Burden Interview (ZBI) for caregiver, followed by provision of standard educational material from the AA and Association for the Advancement of Retired Persons (AARP). Two phone sessions with a study nurse will occur post-enrollment in months 1 and 6 to discuss the educational material and perform a needs assessment; a summary of these and professional education on national evidence-based guidelines will be mailed to the patient's PCP of record. Education provided in this arm will be both patient- and caregiver-centered. |
| Integrated Dementia Practice Unit Arm | Experimental | Other: Integrated Dementia Practice Unit DesignThe integrated practice unit design is a coordinated, team-based, comprehensive, technology enabled, family focused care delivery design comprised of: * Dementia Central: Nurses, physicians, psychologists, social workers, and other relevant healthcare providers that will meet monthly to review participants progress and issues. Telehealth visits would facilitate home care. * Dementia Mobile: A nurse and lay health educator team will perform monthly visits, conduct assessments of subjects and provide education/coaching. * Dementia Link: Technologies that facilitate communication between Dementia Central and Dementia Mobile and foster proactive collaboration/coaching for study subjects include an mHealth software that allows for real time intervention/communication between professional teams and dyads, combined with management of dyads for multiple parameters like health metrics, behavioral measures and stress management and a portal tailored to specific clinical needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Alzheimer's Disease or Vascular Dementia diagnosis provided by a study investigator
- 2 or 3 on the Clinical Dementia Rating Scale at time of enrollment
- Mini Mental Status Examination score of >10 or <25 administered at the time of enrollment
- Willingness and ability to provide patient or surrogate consent, and since caregiver cooperation will be an integral part of this study, an ability to provide caregiver consent to participate
Key exclusion criteria (3 listed)
- Individuals with Mild Cognitive Impairment
- Institutionalized individuals (extended care facility, nursing home, group home, or similar institutional setting)
- Individuals who in the opinion of the investigator cannot be enrolled or followed due to geographic or other constraints
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 |
|---|---|---|
| Integrated Dementia Practice Unit Design* Dementia Central: monthly review of participant progress * Dementia Mobile: monthly nurse/lay health educator visits for assessments, education and coaching * Dementia Link: communication between Dementia Central and Dementia Mobile using the eTransX mHealth platform and HealthStream educational interface for care providers and the patient/caregiver dyad. | Other | Integrated Dementia Practice Unit Arm |
| Standard of CareStandard clinical practices of the physician and institution including an initial assessment, Zarit Burden Interview (ZBI) for caregiver, followed by provision of standard patient- and caregiver-centered educational material. Two phone sessions with a study nurse post-enrollment in months 1 and 6 to discuss the educational material and perform a needs assessment. | Other | Standard of Care |
Primary outcome
Days Alive and At Home
Time frame: 12 months
Our primary outcome is days alive at home (DAAH) for an index dementia patient within 1-year of enrollment (defined as days NOT in a hospital, extended care facility, in-patient rehabilitation, hospice, or respite care facility since enrollment).
6 secondary outcomes
Number of Neurobehavioral Changes
Time frame: 24 months
Number of Health Resources Utilized
Time frame: 24 months
Percent of Participants Achieving Chronic Disease Control Based on Risk Factor Averages
Time frame: 24 months
Perceived Social Support of Caregivers
Time frame: 24 months
Assessment of Perceived Strain in Caregivers
Time frame: 24 months
Assessment of Caregiver Stress
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Howard Kirshner, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Dementia Practice Unit Design in people with Dementia, run by Vanderbilt University Medical Center 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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 11 Jan 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Days Alive and At Home (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2022.