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NCT Number: NCT07392606

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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 (€)

  7. 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)

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Iula

CONTACT

[email protected]

+390630154589

Giuseppe Vetrugno

CONTACT

[email protected]

+390630154987

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study 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.

Acronym: PET

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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