Condition category
Circulatory System
Date applied
21/05/2020
Date assigned
23/05/2020
Last edited
22/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Older patients admitted to an cardiac care unit often experience functional decline and sustained disability. Geriatric co-management has demonstrated significant improvements on outcomes in older patients with a hip fracture, but has never been evaluated in the cardiac care setting.
This study introduced a new geriatric co-management programme on the cardiac care units of the University Hospitals Leuven. The aim was to evaluate whether this programme was acceptable and feasible to perform.

Who can participate?
Patients aged 75 years or older admitted for acute cadiovascular disease or transcatheter aortic valve implentation to the cardiac care units of the University Hospitals Leuven and healthcare professionals working on the acute cardiac care units of the University Hospitals Leuven.

What does the study involve?
On admission to the hospital, a comprehensive geriatric assessment was performed, care needs were determined, and an interdisciplinary care plan was drafted. A nurse from the geriatrics department provided daily follow-up until hospital discharge.

What are the possible benefits and risks of participating?
The programme was developed to benefit patients, including a better functional status and less complications. There are no direct risks.

Where is the study run from?
University Hospitals Leuven (Belgium)

When is the study starting and how long is it expected to run for?
January 2015 to May 2018

Who is funding the study?
Onderzoeksraad, KU Leuven (Research Council, KU Leuven), Belgium

Who is the main contact?
Dr Mieke Deschodt, mieke.deschodt@kuleuven.be
Prof. Koen Milisen, koen.milisen@kuleuven.be
Prof. Johan Flamaing, johan.flamaing@uzleuven.be

Trial website

https://gbiomed.kuleuven.be/english/research/50000625/50000630/researchprojects/gcoach

Contact information

Type

Scientific

Primary contact

Dr Mieke Deschodt

ORCID ID

http://orcid.org/0000-0003-1560-2277

Contact details

Gerontology and Geriatrics
UZ Herestraat 49 - box 7003 35
Leuven
3000
Belgium
+32 16 37 76 92
mieke.deschodt@kuleuven.be

Type

Scientific

Additional contact

Prof Koen Milisen

ORCID ID

http://orcid.org/0000-0001-9230-1246

Contact details

Academisch Centrum voor Verpleeg- en Vroedkunde
Kapucijnenvoer 35 blok d - bus 7001
Leuven
3000
Belgium
+32 16 37 79 79
koen.milisen@kuleuven.be

Type

Scientific

Additional contact

Prof Johan Flamaing

ORCID ID

Contact details

Gerontology and Geriatrics
UZ Herestraat 49 - box 7003 35
Leuven
3000
Belgium
+32 16 3 42647
johan.flamaing@uzleuven.be

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

REF 22/15/028

Study information

Scientific title

Implementation of the Geriatric CO-mAnagement for Cardiology patients in the Hospital (G-COACH) programme: a feasibility study

Acronym

G-COACH

Study hypothesis

Is a geriatric co-management programme implemented on the acute cardiac care units of the University Hospitals Leuven considered acceptable and feasible to perform?

Ethics approval

Approved 03/08/2017, The Medical Ethics Committee of the University Hospitals Leuven (Ethische commissie onderzoek UZ Leuven, Herestraat 49, 3000 Leuven, Belgium; +32 16 34 86 00; ec@uzleuven.be), ref: s59543

Study design

One-group experimental single centre feasibility study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Older patients with geriatric profile admitted to cardiac care units

Intervention

Nurse-led geriatric co-management programme, including a comprehensive geriatric assessment on hospital admission, risk stratification, daily follow-up by geriatrics team until hospital discharge, implementation of standardised and evidence-based protocols for geriatric syndromes, early rehabilitation, individual exercise programme, and early discharge planning.

Informed consent is obtained within three days of admission to the cardiac care unit (15 minutes). A nurse enrols the patient in the geriatric co-management programme (30 minutes). A researcher performs an interview and asks about the experiences with the programme (15 minutes). A researcher observes daily health status and whether there are any complications (10 minutes) until discharge from the cardiac care unit. The participation ends when discharged from the hospital.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Experiences with the programme, including self-perceived acceptability and self-perceived feasibility, measured using structured interviews with questionnaires during hospitalisation.

Secondary outcome measures

Measured during hospitalisation on the cardiac care unit. This is case dependent (some patients have a long length of stay, others short) and there is no one fixed timepoint:
1. Reach of the programme, measured using registrations in the electronic patient record
2. Fidelity, measured suing registrations in the electronic patient record
3. Dose, measured suing registrations in the electronic patient record
4. Determinants for implementation, measured using a questionnaire and interviews

Overall trial start date

28/01/2015

Overall trial end date

31/05/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients aged 75 years or older admitted for acute cadiovascular disease or transcatheter aortic valve implentation to the cardiac care units of the University Hospitals Leuven
2. Healthcare professionals working on the acute cardiac care units of the University Hospitals Leuven

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

3 sequential cohorts of 30 patients with follow-up in the geriatric co-management programme; All healthcare professionals with at least 4 weeks of exposure to the geriatric co-management programme

Total final enrolment

199

Participant exclusion criteria

1. Length of stay < 3 days
2. No baseline assessment (included transfers from other units or hospitals)
3. Unable to complete assessment
4. No inform consent
5. Receiving palliative care

Recruitment start date

07/11/2017

Recruitment end date

02/05/2018

Locations

Countries of recruitment

Belgium

Trial participating centre

University Hospitals Leuven
Herestraat 49
Leuven
3000
Belgium

Sponsor information

Organisation

KU Leuven

Sponsor details

Oude markt 13
Leuven
3000
Belgium
+32 16 3 24010
onderzoek@kuleuven.be

Sponsor type

University/education

Website

https://www.kuleuven.be/english/

Funders

Funder type

Research council

Funder name

Onderzoeksraad, KU Leuven

Alternative name(s)

Research Council, KU Leuven

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

Belgium

Results and Publications

Publication and dissemination plan

Presented at a conference (2019 Wintermeeting, Oostende, Belgium) and submitted for publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Koen Milisen (koen.milisen@kuleuven.be). Each request will be considered on a case basis. Reasonable requests include use of baseline data for epidemiological purposes.

Intention to publish date

30/06/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

2018 protocol in https://doi.org/10.1136/bmjopen-2018-023593 (added 22/05/2020)

Publication citations

Additional files

Editorial Notes

22/05/2020: Trial’s existence confirmed by UZ Leuven.