eHealth LiteracyRO_eHEALTHNCT06645496
Evaluation of Technology Acceptance and Electronic Health (Ehealth) Literacy of Patients Undergoing Radiotherapy
A study testing Evaluation of ehealth literacy in people with eHealth Literacy, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Evaluation of technology acceptance and digital health literacy (eHealth literacy) of patients undergoing radiotherapy. In addition, a qualitative survey of data on the patient journey and its influence on overall satisfaction will be conducted Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- eHealth Literacy
- What is being tested?
- Evaluation of ehealth literacy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteGermany
- Study dates
- 7 Oct 2024to 15 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for carrying out radiotherapy
- Capacity to consent
- At least 18 years of age
- Sufficient knowledge of the German language
Who cannot join
- Lack of capacity to consent
- Age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of technology acceptance and digital health literacy (eHealth literacy) of patients undergoing radiotherapy. In addition, a qualitative survey of data on the patient journey and its influence on overall satisfaction will be conducted
Read the detailed description
Examining the acceptance, trust and communication of a novel patient interaction system in a user-centered manner is essential due to several critical factors highlighted in the literature. The integration of technology into healthcare significantly changes the roles and interactions between healthcare stakeholders, including patients, healthcare providers and the technology itself (Kim et al., 2024). As the use of artificial intelligence (AI) and other advanced technologies in clinical decision-making increases, it is crucial to understand how patients perceive and interact with these systems. Research by Kim et al. (2024) emphasizes that patients have different preferences regarding AI autonomy, so it is important to involve them in defining and regularly reassessing the scope of AI support to ensure it is both effective and acceptable (Kim et al., 2024).
Trust in technology is a key factor influencing its acceptance and effectiveness. Patient trust in AI and other digital health tools can be influenced by their experience, perceived reliability and transparency of the technology. Li (2024) discusses that trust is strengthened when the benefits and reliability of the technology are clearly demonstrated. For example, studies on digital twins in antenatal care show that the perceived reliability of AI predictions and personalized care plays an important role in building trust (Li, 2024). Addressing trustworthiness concerns through user-centered design can help build trust by ensuring that the technology is transparent, explainable, and aligned with patients' needs and values.
Effective communication between patients and healthcare providers is an essential prerequisite for shared decision-making, a core principle of patient-centered care. Hao et al. (2024) state that patient-centered shared decision-making improves healthcare outcomes and patient satisfaction by ensuring that patients are well informed and actively involved in their care decisions (Hao et al., 2024). The integration of technology must promote this communication and not hinder it. For example, patient-centered decision aids can improve the quality of decisions and patient satisfaction if they are designed to support shared decision making by providing clear, personalized information that patients can discuss with their healthcare providers (Hao et al., 2024).
Patient acceptance of the technology is also crucial for its successful introduction. Acceptance is influenced by factors such as ease of use, perceived benefits and the extent to which the technology fits into patients' existing routines and workflows. Research by Kambhamettu et al. (2024) suggests that explainability and meaningful engagement with the technology are key to promoting adoption. This aligns with the findings that by involving patients in the development process, potential barriers to acceptance can be identified and removed (Kambhamettu et al., 2024). By ensuring that the technology is intuitive and meets patients' needs, user-centered design practices can facilitate the seamless integration of technology into patients' healthcare.
In addition, Corti (2024) emphasizes the importance of continuous assessment and adjustment of patient-technology interactions to ensure alignment with patient expectations and preferences. This approach ensures that the technology remains relevant and effective over time (Corti, 2024).
The basis for any integration of digital solutions into patient care, for example the integration of ePROMs into patient care, is a high level of digital health literacy. As part of this study, the digital health literacy of patients undergoing radiotherapy will now be examined in a qualitative and quantitative study . In addition, factors influencing digital health literacy and technology acceptance that could prevent these patients from being integrated into digital health solutions will be identified.
- Conditions
- eHealth Literacy
- Being tested
- Evaluation of ehealth literacy
- Keywords
- ehealth literacy, radiotherapy, health-related quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of ehealth literacyOther
All patients undergoing radiotherapy at the Clinic for Radiotherapy (Campus Virchow Klinikum, Campus Benjamin Franklin) will be informed about the possibility of participating in the study (RO_eHEALTH I). If written consent is given, patients will be asked to complete the established questionnaires (EORTC QLQ-C30 and eHEALS) and a questionnaire to collect epidemiological data at their next visit to the respective clinics.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | All patients undergoing radiotherapy at the Clinic for Radiotherapy (Campus Virchow Klinikum, Campus Benjamin Franklin) will be informed about the possibility of participating in the study. If written consent is given, patients will be asked to complete the established questionnaires (EORTC QLQ-C30 and eHEALS) and a questionnaire to collect epidemiological data at their next visit to the respective clinics. Receives: Other: Evaluation of ehealth literacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
eHEALS
The eHEALS questionnaire consists of 16 questions, higher scores mean higher ehealth literacy, scores between 0 and 80
Measured: once during treatment
Secondary outcomes (3)
Health-related Quality of Life
EORTC QLQ C30 Questionnaire, scores between 0 and 100, higher scores means better quality of life
Measured: once during treatment
Epidemiologic data
descriptive assessment of epidemilogic data concerning income, language skills, use of cell phone
Measured: once during treatment
Treatment characteristics
descriptive data on e.g. tumor type, treatment duration, outpatient or inpatient treatment
Measured: once during therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start7 Oct 2024
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for eHealth LiteracyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Franziska Hausmann, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645496
- Sponsor's protocol ID
- EA4/125/24
- Acronym
- RO_eHEALTH
- Status last verified
- Aug 2025
- First submitted
- 15 Oct 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Technology Acceptance and Electronic Health (Ehealth) Literacy of Patients Undergoing Radiotherapy
- ClinicalTrials.gov ID
- NCT06645496
- Acronym / sponsor ID
- RO_eHEALTH / EA4/125/24
- Conditions
- eHealth Literacy
- Keywords
- ehealth literacy, radiotherapy, health-related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 17 Oct 2024 (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.
Evaluation of technology acceptance and digital health literacy (eHealth literacy) of patients undergoing radiotherapy. In addition, a qualitative survey of data on the patient journey and its influence on overall satisfaction will be conducted
Detailed description
Examining the acceptance, trust and communication of a novel patient interaction system in a user-centered manner is essential due to several critical factors highlighted in the literature. The integration of technology into healthcare significantly changes the roles and interactions between healthcare stakeholders, including patients, healthcare providers and the technology itself (Kim et al., 2024). As the use of artificial intelligence (AI) and other advanced technologies in clinical decision-making increases, it is crucial to understand how patients perceive and interact with these systems. Research by Kim et al. (2024) emphasizes that patients have different preferences regarding AI autonomy, so it is important to involve them in defining and regularly reassessing the scope of AI support to ensure it is both effective and acceptable (Kim et al., 2024).
Trust in technology is a key factor influencing its acceptance and effectiveness. Patient trust in AI and other digital health tools can be influenced by their experience, perceived reliability and transparency of the technology. Li (2024) discusses that trust is strengthened when the benefits and reliability of the technology are clearly demonstrated. For example, studies on digital twins in antenatal care show that the perceived reliability of AI predictions and personalized care plays an important role in building trust (Li, 2024). Addressing trustworthiness concerns through user-centered design can help build trust by ensuring that the technology is transparent, explainable, and aligned with patients' needs and values.
Effective communication between patients and healthcare providers is an essential prerequisite for shared decision-making, a core principle of patient-centered care. Hao et al. (2024) state that patient-centered shared decision-making improves healthcare outcomes and patient satisfaction by ensuring that patients are well informed and actively involved in their care decisions (Hao et al., 2024). The integration of technology must promote this communication and not hinder it. For example, patient-centered decision aids can improve the quality of decisions and patient satisfaction if they are designed to support shared decision making by providing clear, personalized information that patients can discuss with their healthcare providers (Hao et al., 2024).
Patient acceptance of the technology is also crucial for its successful introduction. Acceptance is influenced by factors such as ease of use, perceived benefits and the extent to which the technology fits into patients' existing routines and workflows. Research by Kambhamettu et al. (2024) suggests that explainability and meaningful engagement with the technology are key to promoting adoption. This aligns with the findings that by involving patients in the development process, potential barriers to acceptance can be identified and removed (Kambhamettu et al., 2024). By ensuring that the technology is intuitive and meets patients' needs, user-centered design practices can facilitate the seamless integration of technology into patients' healthcare.
In addition, Corti (2024) emphasizes the importance of continuous assessment and adjustment of patient-technology interactions to ensure alignment with patient expectations and preferences. This approach ensures that the technology remains relevant and effective over time (Corti, 2024).
The basis for any integration of digital solutions into patient care, for example the integration of ePROMs into patient care, is a high level of digital health literacy. As part of this study, the digital health literacy of patients undergoing radiotherapy will now be examined in a qualitative and quantitative study . In addition, factors influencing digital health literacy and technology acceptance that could prevent these patients from being integrated into digital health solutions will be identified.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Other: Evaluation of ehealth literacyAll patients undergoing radiotherapy at the Clinic for Radiotherapy (Campus Virchow Klinikum, Campus Benjamin Franklin) will be informed about the possibility of participating in the study. If written consent is given, patients will be asked to complete the established questionnaires (EORTC QLQ-C30 and eHEALS) and a questionnaire to collect epidemiological data at their next visit to the respective clinics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Indication for carrying out radiotherapy
- Capacity to consent
- At least 18 years of age
- Sufficient knowledge of the German language
Key exclusion criteria (2 listed)
- Lack of capacity to consent
- Age <18 years
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 |
|---|---|---|
| Evaluation of ehealth literacyAll patients undergoing radiotherapy at the Clinic for Radiotherapy (Campus Virchow Klinikum, Campus Benjamin Franklin) will be informed about the possibility of participating in the study (RO_eHEALTH I). If written consent is given, patients will be asked to complete the established questionnaires (EORTC QLQ-C30 and eHEALS) and a questionnaire to collect epidemiological data at their next visit to the respective clinics. | Other | Study Arm |
Primary outcome
eHEALS
Time frame: once during treatment
The eHEALS questionnaire consists of 16 questions, higher scores mean higher ehealth literacy, scores between 0 and 80
3 secondary outcomes
Health-related Quality of Life
Time frame: once during treatment
Epidemiologic data
Time frame: once during treatment
Treatment characteristics
Time frame: once during therapy
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 28 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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 Evaluation of ehealth literacy in people with eHealth Literacy, run by Charite University, Berlin, Germany at 1 site in Germany.
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 4 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: finished, as of the sponsor's last update on 28 Aug 2025. 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 Germany. 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?
eHEALS (time frame: once during treatment). 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 28 Aug 2025.