University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
NCT Number: NCT02890927
The primary objective of the evaluation study is to determine if geriatric co-management is superior to standard of care in preventing functional decline in older patients admitted for acute heart disease or Transcatheter Aortic Valve Implementation (TAVI) to the cardiology units of the University Hospitals Leuven.
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Notify Me75 year and older
All sexes
Interventional
Not applicable
Leuven, Vlaams-Brabant, 3000, Belgium
This study aims to implement and evaluate a geriatric co-management intervention in older patients admitted for acute heart disease or Transcatheter Aortic Valve Implementation (TAVI) to the cardiology units of the University Hospitals Leuven. The study uses a mixed-methods methodology aiming to 1) assess the feasibility and evaluate the effectiveness of geriatric co-management, 2) describe the experiences of intervention participants, and 3) perform a process evaluation. We will first consecutively recruit patients on the cardiology units to measure the standard of care in the control group. The geriatric co-management intervention will then be implemented and piloted on the participating units. Once fully implemented, we will consecutively recruit patients for the intervention group who will receive the geriatric co-management intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients will be included if they:
Exclusion criteria
Patients will be excluded if they:
A comprehensive geriatric assessment on admission will stratify patients in groups:
Time frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
A difference of 1 point on the Katz Index will be considered clinically relevant.
Time frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
A decline of 1 point between admission and discharge on the Katz Index will be considered clinically relevant.
Time frame: Hospital admission (baseline), hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Time frame: Hospital admission (baseline), and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Time frame: Hospital admission (baseline), up to at hospital discharge around an average of 12 days.
The SPPB consist of gait speed, balance test, and chair stand test.
Time frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Isometric handgrip force will be measured with a hydraulic hand dynamometer (Jamar dynamometer; JA Preston Corporation; Jackson, MI).
Time frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Time frame: Hospital admission (baseline) and on day 3, 5, 7 and 9 (or every day when a patient is delirious).
Time frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Time frame: Hospital admission (baseline), hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
A fall incident is defined as an unexpected event in which the patient comes to rest on the ground, floor or lower level. Fall related injuries will be divided in two groups: minor and major.
Time frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Obstipation is defined as not having passed stool in five days or more.
Time frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Time frame: hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
New admission to nursing home or skilled nursing facility
Time frame: 30 days follow-up after hospital discharge.
Time frame: Hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Time to death
Time frame: Hospital admission (baseline), hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Time frame: Hospital admission (baseline), hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Time frame: At 30 days, 3 months and 6 months follow-up after hospital discharge.
Functional status will be measured using the Katz Index of Activities of Daily Living.
Time frame: up to 6 months follow-up after hospital discharge
Time to the first unplanned hospital readmission
Time frame: Between hospital admission and discharge, an average of 12 days
Costs registered for to the treatment, care, logistics and stay in the hospital
Time frame: Through study completion, an average of 1 year.
The interviews will focus on implementation determinants and the interaction of the intervention with the context in which it was implemented.
Time frame: Through study completion, an average of 1 year.
Reach is defined as the number of eligible patients receiving the intervention.
Time frame: Through study completion, an average of 1 year.
Fidelity is defined as the extent to which the intervention was implemented as defined in the protocol.
Time frame: Through study completion, an average of 1 year.
Dose is defined as the number of intervention components delivered as defined in the protocol.
Universitaire Ziekenhuizen KU Leuven
Other
Quasi-experimental Before-and-after Study to Compare the Effectiveness of Geriatric Co-management on Preventing Functional Decline as Compared to Standard of Care in Older Cardiology Patients
Acronym: G-COACH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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