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van CCT (UK)

van CCT (UK)

Cardiac Care Bridge trial

- candidate number27058
- NTR NumberNTR6316
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-apr-2017
- Secondary IDsMETC2016_024 (AMC) NL55636.018.16 (CCMO)
- Public TitleCardiac Care Bridge trial
- Scientific TitleCardiac Care Bridge trial
- hypothesisWith the Cardiac Care Bridge trial, we hypothesize a 12.5% absolute risk reduction on the composite endpoint of first all-cause unplanned hospital readmission or mortality within six months after randomization.
- Healt Condition(s) or Problem(s) studiedAcute myocardial infarction , Geriatrics
- Inclusion criteria- 70 years and older
- Admitted patients to the departments of cardiology or cardiac surgery
- Admission > 48 hours
- High risk of functional decline according to the VMS screening-tool for frailty of the Dutch Safety Management Program (screening on ADL-functioning, fall risk, malnutrition and delirium): score >=2 in patients aged 70-79 years and score >= 1 in patients aged 80 years and older
- Mini-Mental State Examination Score (MMSE) >= 15
- Exclusion criteria- Congenital heart disease
- Terminal illness: defined as a life expectancy of less than three months, for example because of cancer or serious heart failure.
- Transferred from or planned discharge to a nursing home
- Planned discharge to another hospital not participating in this study
- Unable to communicate in Dutch
- Delirium as confirmed by the treating physician
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 6-jun-2017
- planned closingdate1-jul-2019
- Target number of participants500
- InterventionsPatients admitted to the department of cardiology or cardiac surgery of > 70 years, at high risk of functional loss and admitted > 48 hours are eligible for inclusion. The program combines case management, disease management and home-based cardiac rehabilitation. All participants will receive a comprehensive geriatric assessment (CGA), performed by a cardiac nuse. Participants in the intervention group will receive care based on identified problems from the CGA in three phases.
1.In the clinical phase, an integrated care plan will be established for all participants. The department of geriatrics will be consulted in case of at least 1 identified problem on the psychological domain or minimal 5 identified geriatric problems in general.
2. In the transitional phase, before discharge, a coordinating community care registered nurse (CCRN) visits the participant in the hospital to receive a face-to-face handover from the cardiac nurse.
3. The post-clinical phase consists of four home visits by the CCRN to continue care based on the integrated care plan, including cardiovascular risk management and evaluation of participants' health status. The CCRN works in close collaboration with the physiotherapist, who will perform nine home-based cardiac rehabilitation sessions to improve participants' functional status.
- Primary outcomeThe incidence of the composite end-point of first all-cause unplanned hospital readmission or mortality
- Secondary outcome- The incidence proportion of the composite end-point of first all-cause unplanned hospital readmission or mortality
- ADL-functioning and iADL-functioning
- Functional capacity
- Medication adherence
- Anxiety
- Depression
- Health-related quality of life
- Healthcare utilization
- Caregiver burden
- TimepointsThe primary outcome will be measured at six months. Secondary outcomes will be measured at three months (phone), six months (home visit) and twelve months (phone)
- Trial web
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIESProf. Dr. W.J.M. Scholte op Reimer
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Zon-MW 'From knowledge to Action II programí, grant number 520002002
- PublicationsNot applicable
- Brief summaryAfter a hospital admission for heart disease, older patients are at high risk of adverse outcomes such as readmission and death. The current treatment in older cardiac patients is focused on disease management while less attention is paid to general healthcare needs. In the Cardiac Care Bridge (CCB) program we aim to examine the effectiveness of a nurse-coordinated transitional intervention including case management, cardiovascular risk management and home-based rehabilitation for older cardiac patients at high risk of functional loss.
- Main changes (audit trail)Inclusion criterium NEW
Per 28 February 2018, patients with an unplanned hospital admission in the previous six months are also eligible for inclusion (independent of the score on the VMS screening tool for frailty)
- RECORD6-apr-2017 - 29-apr-2018

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