IBDPETNCT07392606
Validation of PET Questionnaire for Experience and Sustainability in Telemedicine. PET(Patient Experience in Telehealth)
An observational study of IBD and Arrythmia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Background: Telemedicine adoption has expanded rapidly in recent years, creating new opportunities for access to care, particularly for frail patients or those with mobility limitations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD, Arrythmia, Radiation Therapy Complication
- What is being tested?
- Patient Experience in Telehealth (PET) - questionnaire
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Feb 2027
- Phase
- Observational
- 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
Study population: The study population will consist of adult patients (≥18 years) who have received at least one telemedicine healthcare service at the Fondazione Policlinico Universitario A. Gemelli IRCCS (FPG IRCCS) across one or more specialist clinical areas. Participants will be consecutively recruited during the predefined data-collection period from among patients who received telemedicine services in the three months preceding study initiation, ensuring a heterogeneous sample with respect to age, sex, clinical condition, and level of digital familiarity.
Who may be able to join
- Age ≥18 years
- Receipt of at least one telemedicine service at FPG IRCCS
- Provision of informed consent to participate in the study.
Who cannot join
- Cognitive or linguistic difficulties preventing comprehension of the questionnaire, in the absence of an available caregiver to provide assistance.
- Exclusive use of telemonitoring services or asynchronous reporting, as the survey focuses on synchronous interactions (e.g., video consultation).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Patient Experience in Telemedicine: Validation of the Co-designed "Patient Experience in Telehealth (PET)" Questionnaire to Measure Experience and Assess Environmental, Economic and Organizational Impact.
Background: Telemedicine adoption has expanded rapidly in recent years, creating new opportunities for access to care, particularly for frail patients or those with mobility limitations. However, the large-scale deployment of remote healthcare services has highlighted the lack of validated instruments to systematically and multidimensionally assess patients' subjective experience. Patient experience is recognized as a key indicator of quality of care, with direct implications for treatment adherence, appropriate use of digital health technologies, and the effectiveness of organizational care models.
Rationale: No instruments have been specifically validated in Italy to measure patient experience in telemedicine. In response, the Fondazione Policlinico Universitario A. Gemelli - Istituto di Ricovero e Cura a Carattere Scientifico (FPG IRCCS) developed, through a co-design process involving expert patients and healthcare professionals, the Patient Experience in Telehealth questionnaire (PET). The tool was designed to capture not only overall satisfaction, but also relational, informational, and organizational domains, as well as perceived economic and environmental impact.
Read more
Objectives: The primary objective is psychometric validation of PET, assessing reliability and validity (construct, convergent, and discriminant). Secondary objectives include evaluating the perceived impact of telemedicine on care organization, patient-borne costs, and the environment, and exploring differences according to sociodemographic variables.
Methods: This cross-sectional observational study will administer PET to at least 200 adult patients who received one or more telemedicine services at FPG IRCCS within the preceding three months. Content validity will be assessed by an expert panel. Descriptive analyses, exploratory factor analysis (EFA), confirmatory factor analysis (CFA), and reliability testing will be performed. A subgroup will complete a test-retest assessment after 7-14 days.
Hypothesis: PET is expected to demonstrate satisfactory psychometric properties, discriminate across different levels of patient experience, and capture the perceived organizational, economic, and environmental impacts of telemedicine in healthcare delivery.
- Conditions
- IBD, Arrythmia, Radiation Therapy Complication
- Being tested
- Patient Experience in Telehealth (PET) - questionnaire
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Experience in Telehealth (PET) - questionnaireOther
The Patient Experience in Telehealth (PET) questionnaire was developed through a co-design process involving patients and healthcare professionals. The questionnaire includes a sociodemographic and telemedicine profile, followed by five Likert-scale sections covering access and technology use (6 items), communication with healthcare staff (5 items), privacy and safety (3 items), comfort, organization and integration of care (5 items), and economic and environmental impact (5 items). A general satisfaction section includes four items, plus one open-ended item for improvement suggestions. A supplementary in-depth section includes 11 items exploring avoided travel, time savings, caregiver involvement, device use, and interest in an automated carbon dioxide (CO₂) estimate. The questionnaire comprises 39 closed-ended items, 4 satisfaction items, 11 in-depth items, and 1 open-ended item. Completion time is approximately 10-15 minutes, and the survey is administered online in anonymous form.
What is being measured
The primary outcome is the main question the study is designed to answer.
Construct validity of the Patient Experience in Telehealth (PET) questionnaire
Construct validity of the PET questionnaire assessed through exploratory and confirmatory factor analysis.
Measured: 1 month
Internal consistency and test-retest reliability of the Patient Experience in Telehealth (PET) questionnaire
Reliability of the PET questionnaire assessed by internal consistency and temporal stability.
Measured: 1 month
Secondary outcomes (8)
Overall satisfaction score measured by the Patient Experience in Telehealth (PET) questionnaire
Overall satisfaction with telemedicine services measured using a numeric rating scale included in the PET questionnaire. Score 0-10 (minimum 0, maximum 10)
Measured: 1 month
Accessibility score measured by the Patient Experience in Telehealth (PET) questionnaire
Perceived accessibility of telemedicine services. Mean Likert-scale score (1-5)
Measured: 1 month
Usability score measured by the Patient Experience in Telehealth (PET) questionnaire
Perceived ease of use of telemedicine technology. Mean Likert-scale score (1-5)
Measured: 1 month
Perceived effectiveness score measured by the Patient Experience in Telehealth (PET) questionnaire
Perceived clinical effectiveness of telemedicine healthcare services. Mean Likert-scale score (1-5)
Measured: 1 month
Organizational impact score measured by the Patient Experience in Telehealth (PET) questionnaire
Perceived impact on waiting times, care pathway simplification, and continuity of care. Mean Likert-scale score (1-5)
Measured: 1 month
Patient-reported economic impact measured by the Patient Experience in Telehealth (PET) questionnaire
Perceived reduction in patient-borne costs, including travel expenses and avoided work leave. Likert-scale score (1-5) and self-reported avoided costs (€)
Measured: 1 month
Patient-reported environmental impact measured by the Patient Experience in Telehealth (PET) questionnaire.
Perceived reduction in travel and associated environmental impact. Likert-scale score (1-5) and avoided travel distance (kilometers)
Measured: 1 month
Association between PET domain scores and sociodemographic and clinical variables
Association between patient experience dimensions and participant characteristics, including age, educational level, and digital familiarity. Correlation coefficients and group comparisons
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Vetrugno, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392606
- Sponsor's protocol ID
- 8198
- Acronym
- PET
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient Experience in Telemedicine: Validation of the Co-designed "Patient Experience in Telehealth (PET)" Questionnaire to Measure Experience and Assess Environmental, Economic and Organizational Impact.
- ClinicalTrials.gov ID
- NCT07392606
- Acronym / sponsor ID
- PET / 8198
- Conditions
- IBD, Arrythmia, Radiation Therapy Complication
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 6 Feb 2026 (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.
Background: Telemedicine adoption has expanded rapidly in recent years, creating new opportunities for access to care, particularly for frail patients or those with mobility limitations. However, the large-scale deployment of remote healthcare services has highlighted the lack of validated instruments to systematically and multidimensionally assess patients' subjective experience. Patient experience is recognized as a key indicator of quality of care, with direct implications for treatment adherence, appropriate use of digital health technologies, and the effectiveness of organizational care models.
Rationale: No instruments have been specifically validated in Italy to measure patient experience in telemedicine. In response, the Fondazione Policlinico Universitario A. Gemelli - Istituto di Ricovero e Cura a Carattere Scientifico (FPG IRCCS) developed, through a co-design process involving expert patients and healthcare professionals, the Patient Experience in Telehealth questionnaire (PET). The tool was designed to capture not only overall satisfaction, but also relational, informational, and organizational domains, as well as perceived economic and environmental impact.
Objectives: The primary objective is psychometric validation of PET, assessing reliability and validity (construct, convergent, and discriminant). Secondary objectives include evaluating the perceived impact of telemedicine on care organization, patient-borne costs, and the environment, and exploring differences according to sociodemographic variables.
Methods: This cross-sectional observational study will administer PET to at least 200 adult patients who received one or more telemedicine services at FPG IRCCS within the preceding three months. Content validity will be assessed by an expert panel. Descriptive analyses, exploratory factor analysis (EFA), confirmatory factor analysis (CFA), and reliability testing will be performed. A subgroup will complete a test-retest assessment after 7-14 days.
Hypothesis: PET is expected to demonstrate satisfactory psychometric properties, discriminate across different levels of patient experience, and capture the perceived organizational, economic, and environmental impacts of telemedicine in healthcare delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients (≥18 years) who have received at least one telemedicine healthcare service at the Fondazione Policlinico Universitario A. Gemelli IRCCS (FPG IRCCS) across one or more specialist clinical areas. Participants will be consecutively recruited during the predefined data-collection period from among patients who received telemedicine services in the three months preceding study initiation, ensuring a heterogeneous sample with respect to age, sex, clinical condition, and level of digital familiarity.
Key inclusion criteria (3 listed)
- Age ≥18 years
- Receipt of at least one telemedicine service at FPG IRCCS
- Provision of informed consent to participate in the study.
Key exclusion criteria (2 listed)
- Cognitive or linguistic difficulties preventing comprehension of the questionnaire, in the absence of an available caregiver to provide assistance.
- Exclusive use of telemonitoring services or asynchronous reporting, as the survey focuses on synchronous interactions (e.g., video consultation).
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 |
|---|---|---|
| Patient Experience in Telehealth (PET) - questionnaireThe Patient Experience in Telehealth (PET) questionnaire was developed through a co-design process involving patients and healthcare professionals. The questionnaire includes a sociodemographic and telemedicine profile, followed by five Likert-scale sections covering access and technology use (6 items), communication with healthcare staff (5 items), privacy and safety (3 items), comfort, organization and integration of care (5 items), and economic and environmental impact (5 items). A general satisfaction section includes four items, plus one open-ended item for improvement suggestions. A supplementary in-depth section includes 11 items exploring avoided travel, time savings, caregiver involvement, device use, and interest in an automated carbon dioxide (CO₂) estimate. The questionnaire comprises 39 closed-ended items, 4 satisfaction items, 11 in-depth items, and 1 open-ended item. Completion time is approximately 10-15 minutes, and the survey is administered online in anonymous form. | Other | – |
Primary outcome
Construct validity of the Patient Experience in Telehealth (PET) questionnaire
Time frame: 1 month
Construct validity of the PET questionnaire assessed through exploratory and confirmatory factor analysis.
Internal consistency and test-retest reliability of the Patient Experience in Telehealth (PET) questionnaire
Time frame: 1 month
Reliability of the PET questionnaire assessed by internal consistency and temporal stability.
8 secondary outcomes
Overall satisfaction score measured by the Patient Experience in Telehealth (PET) questionnaire
Time frame: 1 month
Accessibility score measured by the Patient Experience in Telehealth (PET) questionnaire
Time frame: 1 month
Usability score measured by the Patient Experience in Telehealth (PET) questionnaire
Time frame: 1 month
Perceived effectiveness score measured by the Patient Experience in Telehealth (PET) questionnaire
Time frame: 1 month
Organizational impact score measured by the Patient Experience in Telehealth (PET) questionnaire
Time frame: 1 month
Patient-reported economic impact measured by the Patient Experience in Telehealth (PET) questionnaire
Time frame: 1 month
Patient-reported environmental impact measured by the Patient Experience in Telehealth (PET) questionnaire.
Time frame: 1 month
Association between PET domain scores and sociodemographic and clinical variables
Time frame: 1 month
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 6 Feb 2026.
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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.
Giuseppe Vetrugno principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of IBD and Arrythmia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 3 inclusion and 2 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 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Giuseppe Vetrugno (+390630154987, giuseppe.vetrugno@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Construct validity of the Patient Experience in Telehealth (PET) questionnaire (time frame: 1 month). The study lists 2 primary outcomes in all. 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 6 Feb 2026.