RAPIDE: The Feasibility of a Hybrid Care Model

September 11, 2025 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • Terminally ill patients
  • Comorbidity of a severe psychiatric disorder (i.e. psychosis-related disorders, dementia, and bipolar disorder)
  • Patients who are cognitively impaired

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hybrid care
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
At enrolment, at six months after enrolment, and at twelve months after enrolment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Episodes of care consumption, using patient chart reviews
Time Frame: At baseline and 12 months after enrolment
At baseline and 12 months after enrolment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability and feasibility from the perspective of patients, informal caregivers, and healthcare professionals, using observations and interviews
Time Frame: Six and twelve months after enrolment.
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.
Six and twelve months after enrolment.
Implementation feasibility, using observations and interviews
Time Frame: Six and twelve months after enrolment.
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).
Six and twelve months after enrolment.
Changes in practice organisation and care delivery, using observations and interviews
Time Frame: Six and twelve months after enrolment.
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.
Six and twelve months after enrolment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

December 16, 2024

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-17762

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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