- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02388711
A Trial of the C-TraC Intervention for Dementia Patients
A Randomized Control Trial of the Coordinated-Transitional Care (C-TraC) Intervention for Dementia Patients
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
14, 30 and 90-days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
14, 30 and 90-days
|
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.
|
14, 30 and 90-days
|
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.
|
14, 30 and 90-days
|
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. |
14, 30 and 90-days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Amy J Kind, MD, PhD, University of Wisconsin - Madison, School of Medicine and Public Health, Department of Medicine
Publications and helpful links
General Publications
- Naylor MD, Brooten D, Campbell R, Jacobsen BS, Mezey MD, Pauly MV, Schwartz JS. Comprehensive discharge planning and home follow-up of hospitalized elders: a randomized clinical trial. JAMA. 1999 Feb 17;281(7):613-20. doi: 10.1001/jama.281.7.613.
- Naylor MD, Brooten DA, Campbell RL, Maislin G, McCauley KM, Schwartz JS. Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial. J Am Geriatr Soc. 2004 May;52(5):675-84. doi: 10.1111/j.1532-5415.2004.52202.x. Erratum In: J Am Geriatr Soc. 2004 Jul;52(7):1228.
- Coleman EA, Parry C, Chalmers S, Min SJ. The care transitions intervention: results of a randomized controlled trial. Arch Intern Med. 2006 Sep 25;166(17):1822-8. doi: 10.1001/archinte.166.17.1822.
- Marin DB, Dugue M, Schmeidler J, Santoro J, Neugroschl J, Zaklad G, Brickman A, Schnur E, Hoblyn J, Davis KL. The Caregiver Activity Survey (CAS): longitudinal validation of an instrument that measures time spent caregiving for individuals with Alzheimer's disease. Int J Geriatr Psychiatry. 2000 Aug;15(8):680-6. doi: 10.1002/1099-1166(200008)15:83.0.co;2-7.
- Hurd MD, Martorell P, Langa KM. Monetary costs of dementia in the United States. N Engl J Med. 2013 Aug 1;369(5):489-90. doi: 10.1056/NEJMc1305541. No abstract available.
- Bourgeois MS, Camp C, Rose M, White B, Malone M, Carr J, Rovine M. A comparison of training strategies to enhance use of external aids by persons with dementia. J Commun Disord. 2003 Sep-Oct;36(5):361-78. doi: 10.1016/s0021-9924(03)00051-0.
- Tractenberg RE, Schafer K, Morris JC. Interobserver disagreements on clinical dementia rating assessment: interpretation and implications for training. Alzheimer Dis Assoc Disord. 2001 Jul-Sep;15(3):155-61. doi: 10.1097/00002093-200107000-00007.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-1221
- A534255 (Other Identifier: UW Madison)
- SMPH\MEDICINE\GER-AD DEV (Other Identifier: UW Madison)
- 2P50AG033514-06 (NIH)
- Protocol Version 8/21/2018 (OTHER: UW Madison)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dementia
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedAlzheimer Dementia | Dementia Alzheimers | CaregiverUnited States
-
Temple UniversityRecruitingDementia | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Hebrew SeniorLifeRecruitingAging | Alzheimer Dementia | Presenile Alzheimer DementiaUnited States
-
Temple UniversityRecruitingDementia | Alzheimer Disease | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
National Tainan Junior College of NursingCompletedCognitive Impairment | Dementia, Mild | Dementia ModerateTaiwan
-
Karen RobertoNational Institute on Aging (NIA)RecruitingDementia | Dementia Alzheimers | Neuro-Degenerative Disease | Dementia of Alzheimer Type | Dementia SevereUnited States
-
Cognito Therapeutics, Inc.Enrolling by invitationExtension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)Cognitive Impairment | Alzheimer Disease | Mild Cognitive Impairment | Dementia Alzheimers | Dementia of Alzheimer Type | AD | Dementia, Mild | Dementia ModerateUnited States
-
University College, LondonNot yet recruitingDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal | DEM
-
University College, LondonThe University of Hong KongUnknownDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal
-
Karolinska InstitutetRegion Stockholm; KTH Royal Institute of TechnologyActive, not recruitingAlzheimer Dementia | Dementia DisordersSweden
Clinical Trials on C-TraC Intervention
-
Rhode Island HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedRisk Behavior | Risk Reduction | Emotion RegulationUnited States
-
University of Wisconsin, MadisonNational Institute on Drug Abuse (NIDA)Enrolling by invitationHepatitis C | HIV | Substance Use DisordersUnited States
-
Harvard UniversityCompletedDepression | Anxiety | Trauma | Behavior ProblemsUnited States
-
Memorial Sloan Kettering Cancer CenterTakedaRecruitingB-Cell Lymphoma | Large B-cell Lymphoma | DLBCL, Nos Genetic Subtypes | Mediastinal Large B-cell Lymphoma | High-grade B Cell LymphomaUnited States
-
University Medical Center GroningenRecruiting
-
U.S. Army Medical Research and Development CommandPPD; Idorsia Pharmaceuticals Ltd.; Berry Consultants; Cambridge Cognition Ltd; Ci...RecruitingPost Traumatic Stress DisorderUnited States
-
Transplant Genomics, Inc.University of British Columbia; University of California, Los Angeles; University...Recruiting
-
Transplant Genomics, Inc.Recruiting
-
University of AlbertaCompletedCongenital Heart Disease | Heart; Surgery, Heart, Functional Disturbance as ResultCanada
-
Carolyn LaucknerNational Cancer Institute (NCI)RecruitingCancer | Alcohol UseUnited States