Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial of the C-TraC Intervention for Dementia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02388711
Recruitment Status : Recruiting
First Posted : March 17, 2015
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The goal of the project is to conduct a prospective, randomized-controlled clinical trial to determine the extent to which the Coordinated-Transitional Care (C-TraC) program impacts transitional care quality, patient cognition/function, caregiver stress and 30-day rehospitalizations in patients with documented diagnoses of dementia discharged from the hospital to the community.

Condition or disease Intervention/treatment Phase
Dementia Other: C-TraC Intervention Not Applicable

Detailed Description:

Patients with dementia often experience poor quality transitions from the hospital to the community. In response, the investigators developed and piloted the Coordinated-Transitional Care (C-TraC) program--a low-cost, telephone-based intervention designed to improve care coordination and outcomes in hospitalized patients with dementia or other high-risk conditions discharged to community settings.

A single-blind, prospective, randomized-controlled trial will be used with participants being randomly assigned to receive usual (i.e. standard) care, or usual care plus the C-TraC intervention. Outcomes will be assessed via scheduled phone-calls at 14, 30, and 90 days post-hospitalization. A 45-day phone call will also be conducted to complete a brief satisfaction survey with the caregiver about their post-hospital experience.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Control Trial of the Coordinated-Transitional Care (C-TraC) Intervention for Dementia Patients
Study Start Date : March 2015
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: Usual Care with C-TraC Intervention
Patients/caregivers randomized to this group will receive all routine hospital discharge education/materials (same as usual care group), but will also be enrolled in the C-TraC Program. C-TraC is a low-resource, telephone-based, protocol-driven program designed to reduce 30-day rehospitalizations and to improve care transitions during the early post-hospital period.
Other: C-TraC Intervention
C-TraC utilizes a nurse case manager to coordinate the patient's transitional care through active participation in inpatient multidisciplinary discharge rounds, a single brief protocol-driven inpatient encounter, and 1-4 protocol-driven post-hospital telephone calls with the patient/caregiver using spaced retrieval techniques.

No Intervention: Usual Care
Usual care group patients will receive all routine University of Wisconsin Hospital and Clinics (UWHC) discharge education/materials. This includes pharmacy-led medication teaching, physician discussions and routine nursing education. No post hospital education/contact is performed by these providers. Caregivers are sometimes, but not always, involved. Patients may receive home health services, depending on their physician's discharge plan.



Primary Outcome Measures :
  1. Change from baseline in rehospitalizations at 14, 30 and 90-days [ Time Frame: 14, 30 and 90-days ]
    The presence of any rehospitalization will be assessed through a combination of 14, 30 and 90 day structured phone calls directly to patients/caregivers, a detailed review of medical records associated with any of these caregiver/patient reported rehospitalizations, and a detailed review of the patient's UWHC medical records after all phone calls are completed.


Secondary Outcome Measures :
  1. Increase in patient delirium prevention/resolution [ Time Frame: 14, 30 and 90-days ]
    To assess for delirium, the Family Confusion Assessment Method (FAM-CAM) will be used - an 11-item tool designed to detect delirium from the observations of family caregivers.

  2. Patient functional maintenance/recovery [ Time Frame: 14, 30 and 90-days ]
    To assess function, the investigators will use the Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory (ADCS-ADL). ADCS-ADL is a 23 item tool which offers detailed descriptions of each functional activity and asks caregivers to describe the patient's observed actions or behaviors.

  3. Patient falls prevention [ Time Frame: 14, 30 and 90-days ]
    Caregivers will be asked to report the presence and dates of any patient falls since discharge.

  4. Decrease caregiver stress [ Time Frame: 14, 30 and 90-days ]

    To measure caregiver stress the 22-item Zarit Caregiver Burden Scale and the 6-item Caregiver Activation Survey (CAS) will be used. The Zarit Caregiver Burden Scale is used as a measure of caregiver psychological stress and the CAS is used as a measure of time spent caregiving.

    The investigators will also assess caregiver stress using the 9-item Patient Health Questionnaire (PHQ-9) and the 3-item Care Transitions Measure (CTM-3). The PHQ-9 is used to establish provisional depressive disorder diagnoses as well as grade the severity of depressive symptoms. The CTM-3 has been modified to be given to caregivers discussing their experience with coordinating their loved ones care after hospital discharge. The statements ask about when the loved one was in the hospital, when they were preparing to leave the hospital and about their medications.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patient Inclusion Criteria:

  • English-speaking
  • Have a working telephone
  • Hospitalized on medical inpatient wards at UWHC
  • A documented pre-hospitalization diagnosis of dementia.
  • Alzheimer's Disease Cooperative Study - Clinical Dementia Rating (ADCS-CDR) score of > 0
  • Have a family member/informal caregiver who has regular contact with them in the community setting

Caregiver Inclusion Criteria:

  • English-speaking
  • Have a working telephone
  • Have contact with patient a minimum of once per week

Patient Exclusion Criteria:

  • Discharged to institutional settings
  • No identified caregiver
  • Discharged to hospice
  • Followed by complex case management or any form of intensive case management (e.g. transplant, congestive heart failure, dialysis)
  • Score moderate-high on modified ASSIST tool for alcohol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388711


Contacts
Layout table for location contacts
Contact: Amy J Kind, MD, PhD (608) 280-7000 ajk@medicine.wisc.edu

Locations
Layout table for location information
United States, Wisconsin
University of Wisconsin Hospital Recruiting
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Amy J Kind, MD, PhD University of Wisconsin - Madison, School of Medicine and Public Health, Department of Medicine

Publications:

Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02388711     History of Changes
Other Study ID Numbers: 2014-1221
2P50AG033514-06 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

Keywords provided by University of Wisconsin, Madison:
Dementia
Transitional Care
Caregiver

Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders