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NCT06735404Not yet recruiting

RAPIDE: The Feasibility of a Hybrid Care Model

Regular and Unplanned Care Adaptive Dashboard for Cross-border Emergencies (RAPIDE): The Feasibility of a Hybrid Care Model

Source: ClinicalTrials.gov · Last updated 12 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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: * 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 Main study parameters/endpoints: The impact of the hybrid care model on patient reported experiences (PREMs) and patient reported outcomes (PROMs). 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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
180 (estimated)
First submitted
6 Dec 2024
Start date
Jan 2026
Primary completion date
Mar 2027
Lead sponsor
Radboud University Medical Center
NCT number
NCT06735404

What you commit to

  • Study type: Interventional
  • Planned participants: 180
  • From Jan 2026 to the primary completion date, Mar 2027
  • 4 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Comorbidity of a severe psychiatric disorder (i.e. psychosis-related disorders, dementia, and bipolar disorder)

Other

  • Terminally ill patients
  • Patients who are cognitively impaired

Who the study is looking for

  • 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:
  • At least 2 different types of chronic comorbidities (as defined in the list of chronic comorbidities); AND
  • A high number of medical consultations at the GP practice and/or referrals to the hospital in the last 24 months, as identified by the clinical expertise of the treating GP.
    • Patients with chronic heart failure, WITH:
  • At least 2 different types of chronic comorbidities (as defined in the list of chronic comorbidities); AND
  • A high number of medical consultations at the GP practice and/or referrals to the hospital in the last 24 months, as identified by the clinical expertise of the treating GP.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Accademia Italiana Cure Primarie
Coordinator of this site? Confirm its status
VeronaItalyUnknown status
University of Malta
Coordinator of this site? Confirm its status
VallettaMaltaUnknown status
Radboud University Medical Center
Coordinator of this site? Confirm its status
NijmegenNetherlandsUnknown status
Community Health Centre Ljubljana
Coordinator of this site? Confirm its status
LjubljanaSloveniaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.