- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07392606
Validation of PET Questionnaire for Experience and Sustainability in Telemedicine. PET(Patient Experience in Telehealth) (PET)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Giuseppe Vetrugno
- Phone Number: +390630154987
- Email: giuseppe.vetrugno@policlinicogemelli.it
Study Contact Backup
- Name: Angela Iula
- Phone Number: +390630154589
- Email: angela.iula@policlinicogemelli.it
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years
- Receipt of at least one telemedicine service at FPG IRCCS
- Provision of informed consent to participate in the study.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 month
|
|
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.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall satisfaction score measured by the Patient Experience in Telehealth (PET) questionnaire
Time Frame: 1 month
|
Overall satisfaction with telemedicine services measured using a numeric rating scale included in the PET questionnaire.
Score 0-10 (minimum 0, maximum 10)
|
1 month
|
|
Accessibility score measured by the Patient Experience in Telehealth (PET) questionnaire
Time Frame: 1 month
|
Perceived accessibility of telemedicine services.
Mean Likert-scale score (1-5)
|
1 month
|
|
Usability score measured by the Patient Experience in Telehealth (PET) questionnaire
Time Frame: 1 month
|
Perceived ease of use of telemedicine technology.
Mean Likert-scale score (1-5)
|
1 month
|
|
Perceived effectiveness score measured by the Patient Experience in Telehealth (PET) questionnaire
Time Frame: 1 month
|
Perceived clinical effectiveness of telemedicine healthcare services.
Mean Likert-scale score (1-5)
|
1 month
|
|
Organizational impact score measured by the Patient Experience in Telehealth (PET) questionnaire
Time Frame: 1 month
|
Perceived impact on waiting times, care pathway simplification, and continuity of care.
Mean Likert-scale score (1-5)
|
1 month
|
|
Patient-reported economic impact measured by the Patient Experience in Telehealth (PET) questionnaire
Time Frame: 1 month
|
Perceived reduction in patient-borne costs, including travel expenses and avoided work leave.
Likert-scale score (1-5) and self-reported avoided costs (€)
|
1 month
|
|
Patient-reported environmental impact measured by the Patient Experience in Telehealth (PET) questionnaire.
Time Frame: 1 month
|
Perceived reduction in travel and associated environmental impact.
Likert-scale score (1-5) and avoided travel distance (kilometers)
|
1 month
|
|
Association between PET domain scores and sociodemographic and clinical variables
Time Frame: 1 month
|
Association between patient experience dimensions and participant characteristics, including age, educational level, and digital familiarity.
Correlation coefficients and group comparisons
|
1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Giuseppe Vetrugno, Fondazione Policlinico Universitario A. Gemelli, IRCCS
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Pathological Conditions, Signs and Symptoms
- Arrhythmias, Cardiac
- Health Services Administration
- Delivery of Health Care
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Patient Care Management
- Surveys and Questionnaires
- Telemedicine
- 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole
Other Study ID Numbers
- 8198
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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