Diabetes Type 2NCT06735404
RAPIDE: The Feasibility of a Hybrid Care Model
A study testing Hybrid care in people with Diabetes Type 2 and Heart Failure, run by Radboud University Medical Center at 4 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 2, Heart Failure
- What is being tested?
- Hybrid care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jan 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Terminally ill patients
- Comorbidity of a severe psychiatric disorder (i.e. psychosis-related disorders, dementia, and bipolar disorder)
- Patients who are cognitively impaired
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Italy1 site
Accademia Italiana Cure Primarie
Verona
Mereu, alessandro.mereu@gmail.com
Malta1 site
University of Malta
Valletta
Mamo, +35623402340, julian@julianmamo.com
Netherlands1 site
Radboud University Medical Center
Nijmegen
Hamdiui, +31683591809, nora.hamdiui@radboudumc.nl
Huis
Slovenia1 site
Community Health Centre Ljubljana
Ljubljana
Klemenc Ketiš, +38613003941, zalika.klemenc-ketis@zd-lj.si
About this study
Official title: 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.
Read more
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.
- Conditions
- Diabetes Type 2, Heart Failure
- Being tested
- Hybrid care
- Medical subject headings
- Diabetes Mellitus, Type 2, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid careOther
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
| Study group | Role | What they receive |
|---|---|---|
| Hybrid care | Experimental | Not described Receives: Other: Hybrid care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of the hybrid care model on patient reported experiences (PREMs) and patient reported outcomes (PROMs), using the PaRIS questionnaire.
Measured: At enrolment, at six months after enrolment, and at twelve months after enrolment.
Secondary outcomes (1)
Episodes of care consumption, using patient chart reviews
Measured: At baseline and 12 months after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study startJan 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735404
- Sponsor's protocol ID
- 2024-17762
- Status last verified
- Sep 2025
- First submitted
- 6 Dec 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regular and Unplanned Care Adaptive Dashboard for Cross-border Emergencies (RAPIDE): The Feasibility of a Hybrid Care Model
- ClinicalTrials.gov ID
- NCT06735404
- Acronym / sponsor ID
- 2024-17762
- Conditions
- Diabetes Type 2, Heart Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid care | Experimental | Other: Hybrid care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- 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.
- 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.
Key exclusion criteria (3 listed)
- Terminally ill patients
- Comorbidity of a severe psychiatric disorder (i.e. psychosis-related disorders, dementia, and bipolar disorder)
- Patients who are cognitively impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid careThe 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 | Other | Hybrid care |
Primary outcome
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.
1 secondary outcome
Episodes of care consumption, using patient chart reviews
Time frame: At baseline and 12 months after enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid care in people with Diabetes Type 2 and Heart Failure, run by Radboud University Medical Center at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Malta, Netherlands, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.