An interventional study of Hybrid care in Diabetes Type 2 and Heart Failure, sponsored by Radboud University Medical Center. Not yet recruiting at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Health services research
Rationale: During cross-border health emergencies, such as seen with the COVID-19 pandemic, health and care services are rapidly being overwhelmed by high numbers of patients requiring care, leading to stretches in the whole healthcare system. Delays and backlogs in regular care, as the result of the stretched health care services, leave millions of patients with regular care needs unattended, resulting in disastrous healthcare outcomes. If disastrous healthcare outcomes across the population are to be avoided, healthcare systems must become more robust, resilient, and flexible in the face of future health emergencies and allow for rapid changes in the care delivery services.
Objective: To evaluate the feasibility of delivering a hybrid care model alongside care as usual through observations, and questionnaires and interviews on patient reported views, opinions, and experiences. This hybrid care model aims to reduce the burden on health and care systems during a health emergency, decrease the need to scale down regular care, and ensure patient safety and quality of care.
Study design: One year cohort study, using observations, questionnaires, and interviews.
Study population: Patients with type 2 diabetes and/or chronic heart failure with comorbidities and/or having a high care consumption according to the treating general practitioner.
Intervention: The hybrid care model will consist of a combination of digital tools and/or task shifting of certain healthcare providers. Examples are:
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Evaluating the feasibility of this hybrid care model will only be done through observations, questionnaires, and interviews at home (during three home visits at baseline, after six months, and after one year). No invasive (physical) procedures will be performed.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 180 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Patients with type 2 diabetes mellitus, WITH:
Patients with chronic heart failure, WITH:
Exclusion Criteria:
Other: Hybrid care
The hybrid care model will consist of a combination of digital tools and/or task shifting of certain healthcare providers. Examples are: * Telemonitoring: patients perform self-measurements through e.g. sensors, wearables, or (mobile) applications to get insight in their health status (supporting self-management) and report this to their healthcare provider(s), when relevant * Teleconsultation: patients communicate with their healthcare provider(s) remotely * Personal health portals and self-management applications * Online prescription requests: patients request prescription online
The impact of the hybrid care model on patient reported experiences (PREMs) and patient reported outcomes (PROMs), using the PaRIS questionnaire.
Time frame: At enrolment, at six months after enrolment, and at twelve months after enrolment.
Episodes of care consumption, using patient chart reviews
Time frame: At baseline and 12 months after enrolment
Acceptability and feasibility from the perspective of patients, informal caregivers, and healthcare professionals, using observations and interviews
Through observations and interviews, the investigators will evaluate the extent to which the hybrid care model is acceptable and feasible for patients, informal care givers, and healthcare professionals.
Time frame: Six and twelve months after enrolment.
Implementation feasibility, using observations and interviews
Through observations and interviews, the investigators will evaluate the extent to which the new hybrid care model is practically feasible to implement (facilitators and barriers of implementation).
Time frame: Six and twelve months after enrolment.
Changes in practice organisation and care delivery, using observations and interviews
Through observations and interviews, the investigators will evaluate the extent to which the new hybrid care model initiates changes in practice organisation and care delivery.
Time frame: Six and twelve months after enrolment.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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