TelemedicineNCT06171763
The Multi-stakeholder Assessment of Economic and Managerial Determinants and Impacts of Telemedicine
A study testing Telemedicine in people with Telemedicine, run by Buzzi Children's Hospital at 1 site in Italy.
Trial summary
The study aims to conduct a comprehensive evaluation involving multiple stakeholders to assess the factors influencing and the consequences of telehomecare in comparison to traditional care models. Read more about this study
- Who is it for?
- Ages 12 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Telemedicine
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 8 Aug 2022to 8 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age: 0-18 years.
- Gender: Both males and females
- Patients: Hospitalized at the end of treatment.
- Stable Vital Signs (heart rate, respiratory rate, oxygen saturation)
- Stable/Improving/Resolved biochemical Tests.
- Absence of Fever
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- Consent/Assent: Willingness to participate with appropriate consent or assent based on age.
- Proximity to Domicile: Residence within a maximum distance of 45 minutes.
- Adequate Home Facilities.
- Language Proficiency: Adequate knowledge of the Italian language.
- Possession of Compatible Device
Who cannot join
- Refusal to Participate
- Vital Signs Instability
- Presence of Fever
- Deteriorating biochemical Test Results
- Residence More Than 45 Minutes Away
- Inadequate Home Facilities
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- Language Barrier
- Lack of a Compatible Device
- Not owning a device with an operating system suitable for supporting the Tytocare app.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Multi-stakeholder Assessment of Economic and Managerial Determinants and Impacts of Telemedicine: a Comparison Between a Tele-homecare Solution and Traditional Care Models.
The study aims to conduct a comprehensive evaluation involving multiple stakeholders to assess the factors influencing and the consequences of telehomecare in comparison to traditional care models. The integration of technology into the healthcare sector necessitates significant changes in care of patients, organizational structures, production processes, organizational responsibilities, and the management of service delivery processes.
The delivery of telemedicine services through integrated devices represents a method of service production that demands active involvement from patients or, in the case of pediatric patients, their caregivers. This collaborative process of patient engagement in healthcare services is referred to as "co-production." In this research, telehomecare will be examined as an illustrative instance of co-producing healthcare services.
Read more
Co-production implies that the inputs into a production process are contributed not only by the organization producing a good or service but also by the users. In the case study, co-production occurs through the interaction between patients/caregivers and professionals during telehealth visits for device-mediated monitoring activities. Throughout the televisit, patients/caregivers play a crucial role in collecting and sharing the necessary parameters with professionals using the device, thereby serving as essential actors in the care process.
The investigators explored the impact of a transitional care program, utilizing an user-friendly mobile medical device, to support an early discharges in a pediatric setting. Clinical outcome and economic advantages are considered. This study will contribute to implement knowledge on the role of telemedicine on HaH healthcare in pediatrics.
Read the detailed description
This is a single-center, two-arm, randomized, open-label, parallel-group study that was conducted at Buzzi Children's Hospital, a hospital in a metropolis located in Milan (Italy). The different arms consisted of an experimental group with an early discharge adopting telehomecare and a standard care group with in-person physical care until the end of hospitalization.
- Conditions
- Telemedicine
- Being tested
- Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
The telehomecare solution involves an early discharge with continued home monitoring through the use of telemedicine utilizing an user-friendly mobile. Additionally, there were a clinical reassessment in person 72 hours after discharge to evaluate the outcomes and results of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Telehome care | Experimental | For patients/caregivers assigned to the tele-homecare group, before discharge, instruction on the use of the TytoCareTM system was provided by healthcare personnel trained in the use of the system. Subsequently, each patient give the device they used until the scheduled post-discharge clinical assessment. A parent/caregiver was invited to participate for each pediatric patient.
Every 24 hours, the patient was assessed remotely in synchronous teleconsultation by medical staff; during tele-visit, the physician performed the complete routine procedure, including medical history and physical examination with user friendly medical device and completed the data collection sheet.
At 72 hours after discharge, an in-person clinical assessment was scheduled for outcome evaluation. In particular, during the visit, the complete resolution of the disease state was assessed through the post-discharge objective examination. Receives: Other: Telemedicine |
| Standard care | No intervention | Patients remained hospitalized for the continuation of the treatment. Every 24 hours, the patient was assessed in person by medical staff; the traditional physical examination involved assessment of the clinical parameters using standard equipment such as a digital thermometer, conventional stethoscope, and otoscope and completed the same data collection sheet. After 72 hours of hospital observation, an in-person clinical examination was conducted to evaluate the outcome. In particular, during the visit, the complete resolution of the disease state was assessed through the post-discharge objective examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early discharge utilizing an user-friendly mobile medical device
Considering in-person visit as the standard care procedure, the primary objective of this study is to obtain concordance with complete resolution of the disease from in-person physical care, without re-admission to the hospital. The investigators expect non-readmission in a minimum of 90 % of cases.
Outcome measure: count and percentage of patients readmitted to the hospital after early discharge
Measured: 12 months
Secondary outcomes (2)
Length of stay
To record a lower length of stay in interventional group compared to standard care group Outcome measure: days of hospitalization
Measured: 12 months
Economic impact
To compare costs of hospitalization between interventional group compared to standard care group Outcome measure: direct and indirect costs (in euros)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start8 Aug 2022
- Primary completion30 Sep 2023
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buzzi Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valeria Calcaterra, Buzzi Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171763
- Sponsor's protocol ID
- 0033846
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 20 Dec 2023
- 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 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multi-stakeholder Assessment of Economic and Managerial Determinants and Impacts of Telemedicine: a Comparison Between a Tele-homecare Solution and Traditional Care Models.
- ClinicalTrials.gov ID
- NCT06171763
- Acronym / sponsor ID
- 0033846
- Conditions
- Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Buzzi Children's HospitalUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 15 Dec 2023 (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.
The study aims to conduct a comprehensive evaluation involving multiple stakeholders to assess the factors influencing and the consequences of telehomecare in comparison to traditional care models. The integration of technology into the healthcare sector necessitates significant changes in care of patients, organizational structures, production processes, organizational responsibilities, and the management of service delivery processes.
The delivery of telemedicine services through integrated devices represents a method of service production that demands active involvement from patients or, in the case of pediatric patients, their caregivers. This collaborative process of patient engagement in healthcare services is referred to as "co-production." In this research, telehomecare will be examined as an illustrative instance of co-producing healthcare services.
Co-production implies that the inputs into a production process are contributed not only by the organization producing a good or service but also by the users. In the case study, co-production occurs through the interaction between patients/caregivers and professionals during telehealth visits for device-mediated monitoring activities. Throughout the televisit, patients/caregivers play a crucial role in collecting and sharing the necessary parameters with professionals using the device, thereby serving as essential actors in the care process.
The investigators explored the impact of a transitional care program, utilizing an user-friendly mobile medical device, to support an early discharges in a pediatric setting. Clinical outcome and economic advantages are considered. This study will contribute to implement knowledge on the role of telemedicine on HaH healthcare in pediatrics.
Detailed description
This is a single-center, two-arm, randomized, open-label, parallel-group study that was conducted at Buzzi Children's Hospital, a hospital in a metropolis located in Milan (Italy). The different arms consisted of an experimental group with an early discharge adopting telehomecare and a standard care group with in-person physical care until the end of hospitalization.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehome care | Experimental | Other: TelemedicineFor patients/caregivers assigned to the tele-homecare group, before discharge, instruction on the use of the TytoCareTM system was provided by healthcare personnel trained in the use of the system. Subsequently, each patient give the device they used until the scheduled post-discharge clinical assessment. A parent/caregiver was invited to participate for each pediatric patient. Every 24 hours, the patient was assessed remotely in synchronous teleconsultation by medical staff; during tele-visit, the physician performed the complete routine procedure, including medical history and physical examination with user friendly medical device and completed the data collection sheet. At 72 hours after discharge, an in-person clinical assessment was scheduled for outcome evaluation. In particular, during the visit, the complete resolution of the disease state was assessed through the post-discharge objective examination. |
| Standard care | No intervention | –Patients remained hospitalized for the continuation of the treatment. Every 24 hours, the patient was assessed in person by medical staff; the traditional physical examination involved assessment of the clinical parameters using standard equipment such as a digital thermometer, conventional stethoscope, and otoscope and completed the same data collection sheet. After 72 hours of hospital observation, an in-person clinical examination was conducted to evaluate the outcome. In particular, during the visit, the complete resolution of the disease state was assessed through the post-discharge objective examination. |
Who may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Age: 0-18 years.
- Gender: Both males and females
- Patients: Hospitalized at the end of treatment.
- Stable Vital Signs (heart rate, respiratory rate, oxygen saturation)
- Stable/Improving/Resolved biochemical Tests.
Key exclusion criteria (9 listed)
- Refusal to Participate
- Vital Signs Instability
- Presence of Fever
- Deteriorating biochemical Test Results
- Residence More Than 45 Minutes Away
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 |
|---|---|---|
| TelemedicineThe telehomecare solution involves an early discharge with continued home monitoring through the use of telemedicine utilizing an user-friendly mobile. Additionally, there were a clinical reassessment in person 72 hours after discharge to evaluate the outcomes and results of the intervention. | Other | Telehome care |
Primary outcome
Early discharge utilizing an user-friendly mobile medical device
Time frame: 12 months
Considering in-person visit as the standard care procedure, the primary objective of this study is to obtain concordance with complete resolution of the disease from in-person physical care, without re-admission to the hospital. The investigators expect non-readmission in a minimum of 90 % of cases. Outcome measure: count and percentage of patients readmitted to the hospital after early discharge
2 secondary outcomes
Length of stay
Time frame: 12 months
Economic impact
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Telemedicine, run by Buzzi Children's Hospital at 1 site in Italy.
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 11 inclusion and 9 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: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early discharge utilizing an user-friendly mobile medical device (time frame: 12 months). 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 20 Dec 2023.