Team-based Technology-enabled Integrated Patient/Caregiver-focused Dementia Study

Dementia Clinical Trial

— T2IP-DS  

Official title:

Team-based Technology-enabled Integrated Patient/Caregiver-focused Dementia Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04631120
• Other study ID #: 55555
• Status: Withdrawn
• Phase: N/A
• Start date: October 2021
• Est. completion date: October 2026

Study information

• Verified date: December 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2026
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria include:

• 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

Exclusion criteria include:

• 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

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• 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.
• Standard of Care
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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 months
Secondary	Number of Neurobehavioral Changes	Neurobehavioral changes measured by Neuro-Psychiatric Inventory, Cornell Scale for Depression in Dementia	24 months
Secondary	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)	24 months
Secondary	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	24 months
Secondary	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).	24 months
Secondary	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.	24 months
Secondary	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.	24 months