Validation of PET Questionnaire for Experience and Sustainability in Telemedicine. PET(Patient Experience in Telehealth)

NCT07392606 | Not Yet Recruiting

• 1 other identifier: 8198
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

IBD; Arrythmia; Radiation Therapy Complication

Outcome Measures

Primary Outcomes (2)

• Construct validity of the Patient Experience in Telehealth (PET) questionnaire

  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

  Reliability of the PET questionnaire assessed by internal consistency and temporal stability.

  1 month

Secondary Outcomes (8)

• Overall satisfaction score measured by the Patient Experience in Telehealth (PET) questionnaire

  1 month

• Accessibility score measured by the Patient Experience in Telehealth (PET) questionnaire

  1 month

• Usability score measured by the Patient Experience in Telehealth (PET) questionnaire

  1 month

• Perceived effectiveness score measured by the Patient Experience in Telehealth (PET) questionnaire

  1 month

• Organizational impact score measured by the Patient Experience in Telehealth (PET) questionnaire

  1 month

Interventions

Patient Experience in Telehealth (PET) - questionnaire OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Age ≥18 years
• Receipt of at least one telemedicine service at FPG IRCCS
• Provision of informed consent to participate in the study.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Telemedicine; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Giuseppe Vetrugno

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Vetrugno

CONTACT

+390630154987; giuseppe.vetrugno@policlinicogemelli.it

Angela Iula

CONTACT

+390630154589; angela.iula@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-01