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DementiaNCT02388711

A Trial of the C-TraC Intervention for Dementia Patients

A study testing C-TraC Intervention in people with Dementia, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Dementia
What is being tested?
C-TraC Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
584 participants
Where
1 siteUnited States
Study dates
Mar 2015to 11 Oct 2019
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

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisconsin Hospital

    Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: A Randomized Control Trial of the Coordinated-Transitional Care (C-TraC) Intervention for Dementia Patients

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.

Read the 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.

Conditions
Dementia
Being tested
C-TraC Intervention
Keywords
Dementia, Transitional Care, Caregiver
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • C-TraC InterventionOther

    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.

Study groups in NCT02388711
Study groupRoleWhat they receive
Usual Care with C-TraC InterventionExperimentalPatients/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.
Receives: Other: C-TraC Intervention
Usual CareNo interventionUsual 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in rehospitalizations at 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.

    Measured: 14, 30 and 90-days

Secondary outcomes (4)

  1. Increase in patient delirium prevention/resolution

    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.

    Measured: 14, 30 and 90-days

  2. Patient functional maintenance/recovery

    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.

    Measured: 14, 30 and 90-days

  3. Patient falls prevention

    Caregivers will be asked to report the presence and dates of any patient falls since discharge.

    Measured: 14, 30 and 90-days

  4. Decrease caregiver stress

    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.

    Measured: 14, 30 and 90-days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completion11 Oct 2019
  4. Study completion11 Oct 2019

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
584 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02388711
Sponsor's protocol ID
2014-1221
Other IDs
2P50AG033514-06, A534255, SMPH\MEDICINE\GER-AD DEV, Protocol Version 8/21/2018
Status last verified
Feb 2021
First submitted
23 Feb 2015
Last updated
12 Feb 2021
Results posted
No
Data monitoring committee
No

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.

    PubMed 10029122

  • 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.

    PubMed 15086645

  • 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.

    PubMed 17000937

  • 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.

    PubMed 10960880

  • 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.

    PubMed 23902508

  • 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.

    PubMed 12927944

  • 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.

    PubMed 11522933

Questions about this trial

What is this clinical trial studying?

A study testing C-TraC Intervention in people with Dementia, run by University of Wisconsin, Madison 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?

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 12 Feb 2021. 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?

Change from baseline in rehospitalizations at 14, 30 and 90-days (time frame: 14, 30 and 90-days). 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 NCT02388711, which also lists 7 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 12 Feb 2021.

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