RAPIDE: The Feasibility of a Hybrid Care Model

Not Applicable

Not yet recruiting

• Conditions: Diabetes Type 2; Heart Failure

• Registration Number: NCT06735404
• Lead Sponsor: Radboud University Medical Center

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16
• Study Start: 2025-07
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The impact of the hybrid care model on patient reported experiences (PREMs) and patient reported outcomes (PROMs), using the PaRIS questionnaire.	At enrolment, at six months after enrolment, and at twelve months after enrolment.

Secondary Outcome Measures

Name	Time	Method
Episodes of care consumption, using patient chart reviews	At baseline and 12 months after enrolment

Trial Locations

Locations (4)

Accademia Italiana Cure Primarie; 🇮🇹 Verona, Italy

University of Malta; 🇲🇹 Valletta, Malta

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands

Community Health Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia