Palliative CareNCT07692711
Patient Aid for Theory-Driven Health Communication (PATH): Translating Goal-Power Theory Into an Instrument and Generative AI Support for Palliative Care Communication
A study testing NurseChat+ in people with Palliative Care and Generative Artificial Intelligence, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to learn whether an artificial intelligence (AI)-supported communication tool can help improve communication between people receiving palliative care and their healthcare providers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palliative Care, Generative Artificial Intelligence, Natural Language Processing (NLP)
- What is being tested?
- NurseChat+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2026to 31 Dec 2030
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Diagnosed with an advanced disease requiring consultation with outpatient palliative care clinics or home care services.
- Able to self-complete the study questionnaires.
- Age 18 years or older.
- Identified as the primary family caregiver of a patient with an advanced disease requiring palliative care.
Who cannot join
- -None
- Group 2: Caregivers (Proxy-responding) (Invited only when the patient meets the clinical criteria but is unable to self-complete the questionnaires)
- Professional or paid caregivers.
- Unable to complete the study questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Taiwan University Hospital
Taipei
Clinical Trial Center, 886-233668656, rmcore@ntuh.gov.tw
About this study
The goal of this clinical trial is to learn whether an artificial intelligence (AI)-supported communication tool can help improve communication between people receiving palliative care and their healthcare providers. The study will also evaluate a new questionnaire designed to measure the quality of healthcare communication.
The main questions this study aims to answer are:
Read more
- Can the new questionnaire accurately measure the quality of communication between participants and healthcare providers?
- Does using the AI-supported communication tool, called NurseChat+, help participants feel more confident and prepared before meeting with their healthcare team?
- Does NurseChat+ improve the quality of communication during palliative care visits?
Researchers will compare participants who use NurseChat+ together with their usual care to participants who receive usual care alone to see whether the tool improves communication outcomes.
The study will be conducted in three stages. First, researchers will develop and test a questionnaire that measures healthcare communication. Next, they will develop and refine the NurseChat+ tool. Finally, they will test the tool in adults receiving palliative care at National Taiwan University Hospital.
Participants in the final stage of the study will be randomly assigned to one of two groups. One group will use NurseChat+ before their scheduled medical visits in addition to receiving usual care, while the other group will receive usual care only. Participants will complete questionnaires about their communication experiences during the study.
Read the detailed description
Effective health communication is essential to patient well-being, yet the field is constrained by major theoretical and methodological gaps. Existing theories tend to address isolated communication phenomena and lack an integrative framework spanning the full continuum of patient-provider interaction. As a result, many measurement instruments lack a clear theoretical foundation and demonstrate inconsistent psychometric quality. In parallel, most AI-supported communication tools are technology-driven rather than theory-driven, and few have undergone rigorous clinical evaluation. Palliative care represents a high-stakes clinical context in which communication quality is central to outcomes, making it an ideal setting to test theory-based generative artificial intelligence (GenAI) communication interventions.
Grounded in the Goal-Power Theory of Communication developed by the applicant, this four-year project adopts a mixed-methods design to develop and evaluate a theory-based communication measurement instrument and a GenAI-supported communication aid, NurseChat+. The project comprises three sequential phases: (1) instrument development and validation, (2) intervention development and pilot testing, and (3) clinical evaluation using a randomized controlled trial (RCT). Phase 1 aims to develop and psychometrically validate a theory-based instrument for assessing health communication quality. Instrument development and validation will follow the MEASURE framework, including expert content validation and field testing with approximately 500 participants recruited from clinical settings within the National Taiwan University Hospital system. Phase 2 aims to develop and preliminarily validate the NurseChat+ using a user-centered design approach. A pilot usability and feasibility study will be conducted using a one-group pretest-posttest design with a minimum of 20 healthy adults to assess acceptability, usability, and preliminary effects on communication self-efficacy. Phase 3 will conduct a parallel-group, superiority RCT with an embedded mixed-methods design in palliative care outpatient and home care settings at National Taiwan University Hospital. Eligible adult patients receiving palliative care will be randomly allocated in a 1:1 ratio to the intervention group (NurseChat+ plus usual care) or the control group (usual care alone). The target sample size is 240 participants (120 per group). Intervention participants will use NurseChat+ prior to scheduled medical encounters.
- Being tested
- NurseChat+
- Keywords
- Randomized Controlled Trial, Health Communication, Psychometrics, Theoretical Models, Mixed Methods Research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NurseChat+Behavioural
Participants will use NurseChat+, a generative AI-supported communication tool, before scheduled palliative care visits to help prepare questions and concerns for discussion with healthcare providers. The intervention is provided in addition to usual care.
| Study group | Role | What they receive |
|---|---|---|
| NurseChat+ plus usual care | Experimental | Participants in the experimental group will be invited to interact with NurseChat+ on an iPad provided by the research team before beginning their medical consultation. Successful completion of the intervention is defined as either a minimum of ten minutes of NurseChat+ use or completion of a full round of patient input, data retrieval, and response generation Receives: Behavioral: NurseChat+ |
| Usual Care | No intervention | Participants in the control group will receive usual palliative care without access to the NurseChat+ intervention. Usual care includes standard clinical consultations and communication with healthcare providers as provided in routine practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Communication Self-Efficacy via the 5-item Perceived Efficacy in Patient-Physician Interaction Scale (PEPPI-5)
【Randomized Control Trial \& Pilot study】The PEPPI-5 is a 5-item self-report instrument used to measure a patient's perceived self-efficacy in communicating with their physician. Each item is scored on a 5-point Likert scale from 1 (not at all confident) to 5 (very confident). The total score ranges from 5 to 25, with higher scores indicating higher levels of communication self-efficacy. Outcome will be assessed as the change in scores from T0 to T1.
Measured: Baseline (T0: within 12 hours prior to the scheduled consultation) and Post-test (T1: immediately following the medical consultation or the interaction with GenAI communication aid).
Quality of Health Communication via the Phase-One Developed Instrument
Evaluated using a newly developed and validated communication-quality instrument generated in Phase One of the study. This instrument is designed to comprehensively assess the specific communication quality, patterns, and clinical encounter effectiveness between healthcare providers and palliative care patients/families when aided by GenAI communication aid.
The instrument is currently undergoing development and psychometric validation. The finalized total score will be structured such that higher scores will mathematically indicate a superior quality of health communication and better communication patterns.
Measured: Post-test follow-up (T1: 24-72 hours after the consultation via telephone interview).
Secondary outcomes (6)
System Usability Scale (SUS) Score of NurseChat+
【Pilot study】The UEQ contains 26 pairs of contrasting adjectives used to evaluate the user experience of NurseChat+ across 6 scales (Attractiveness, Perspicuity, Efficiency, Dependability, Stimulation, and Novelty). Each item is scored on a 7-point scale ranging from -3 (horrible/extremely bad) to +3 (excellent/extremely good). Scores above 0.8 represent a positive evaluation.
Measured: Post-test (immediately after the interaction with GenAI communication aid).
Inventory of Technology Acceptance Model (ITAM) Score
【Pilot study】The ITAM assesses user acceptance, perceived usefulness, and perceived ease of use regarding the NurseChat+ GenAI system. Items are scored on a 7-point Likert scale, ranging from 1(strongly disagree) to 7 (strongly agre), with higher total scores indicating a higher intention to adopt and greater acceptance of the technology.
Measured: Post-test ( immediately after the interaction with GenAI communication aid)
Evaluation of User Experience via the User Experience Questionnaire (UEQ)
【Pilot study】The UEQ is a 26-item semantic differential scale used to provide a holistic assessment of the user experience of NurseChat+. It measures both pragmatic qualities (efficiency, perspicuity, dependability) and hedonic qualities (stimulation, novelty), along with overall attractiveness. Each item consists of a pair of contrasting adjectives rated on a 7-point scale ranging from 1 to 7.
For analysis, responses are transformed to range from -3 (horribly bad) to +3 (extremely good), where 0 represents a neutral evaluation. Higher positive values reflect a superior user experience, and scale scores above 0.8 generally indicate a positive evaluation.
Measured: Post-test (immediately after the interaction with GenAI communication aid)
Improvement in Symptom Burden via the Edmonton Symptom Assessment System (ESAS)
【Randomized Control Trial】The ESAS is a validated tool designed to assess 9 common symptoms in palliative care patients (pain, tiredness, drowsiness, nausea, appetite, shortness of breath, depression, anxiety, and wellbeing). Each symptom is rated on a visual analogue scale from 0 (no symptom) to 10 (worst possible symptom). The total distress score ranges from 0 to 90, with higher scores indicating a higher symptom burden.
Measured: Baseline (T0: within 12 hours prior to the scheduled consultation) and Post-test (T1: post-consultation follow-up within 24-72 hours).
Patient Overall and Communication Satisfaction via the Chinese Patients' Satisfaction Scale (C-PSS)
【Randomized Control Trial】The C-PSS is a 27-item instrument validated in Taiwan's outpatient population, assessing 6 dimensions: efficiency, fairness, chin-chieh (kindness), professionalism, responsibility, and respect. Each item is rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). With reverse-scored items appropriately adjusted, total scores are aggregated, where higher total scores indicate greater patient communication and overall satisfaction with the clinical encounter.
Measured: Post-test follow-up (T1: 24-72 hours after the consultation via telephone interview).
Patient Satisfaction with Decision Making via the Satisfaction with Decision (SWD) Scale
【Randomized Control Trial】The Chinese version of the SWD is a 6-item questionnaire designed to assess a patient's satisfaction with the healthcare decision-making process and its clinical outcomes. Each item is rated on a 5-point Likert scale. Total scores range from 6 to 30, with higher scores indicating a higher degree of satisfaction and agreement with the decisions made during the medical consultation.
Measured: Post-test follow-up (T1: 24-72 hours after the consultation via telephone interview).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692711
- Sponsor's protocol ID
- 202602057RINB
- Status last verified
- Mar 2026
- First submitted
- 2 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD underlying this study will not be made available to outside researchers. This restriction is necessary to protect patient privacy and to adhere to the informed consent agreements approved by our Institutional Review Board (IRB).
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Aid for Theory-Driven Health Communication (PATH): Translating Goal-Power Theory Into an Instrument and Generative AI Support for Palliative Care Communication
- ClinicalTrials.gov ID
- NCT07692711
- Acronym / sponsor ID
- 202602057RINB
- Keywords
- Randomized Controlled Trial, Health Communication, Psychometrics, Theoretical Models, Mixed Methods Research
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 9 Jul 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.
The goal of this clinical trial is to learn whether an artificial intelligence (AI)-supported communication tool can help improve communication between people receiving palliative care and their healthcare providers. The study will also evaluate a new questionnaire designed to measure the quality of healthcare communication.
The main questions this study aims to answer are:
- Can the new questionnaire accurately measure the quality of communication between participants and healthcare providers?
- Does using the AI-supported communication tool, called NurseChat+, help participants feel more confident and prepared before meeting with their healthcare team?
- Does NurseChat+ improve the quality of communication during palliative care visits?
Researchers will compare participants who use NurseChat+ together with their usual care to participants who receive usual care alone to see whether the tool improves communication outcomes.
The study will be conducted in three stages. First, researchers will develop and test a questionnaire that measures healthcare communication. Next, they will develop and refine the NurseChat+ tool. Finally, they will test the tool in adults receiving palliative care at National Taiwan University Hospital.
Participants in the final stage of the study will be randomly assigned to one of two groups. One group will use NurseChat+ before their scheduled medical visits in addition to receiving usual care, while the other group will receive usual care only. Participants will complete questionnaires about their communication experiences during the study.
Detailed description
Effective health communication is essential to patient well-being, yet the field is constrained by major theoretical and methodological gaps. Existing theories tend to address isolated communication phenomena and lack an integrative framework spanning the full continuum of patient-provider interaction. As a result, many measurement instruments lack a clear theoretical foundation and demonstrate inconsistent psychometric quality. In parallel, most AI-supported communication tools are technology-driven rather than theory-driven, and few have undergone rigorous clinical evaluation. Palliative care represents a high-stakes clinical context in which communication quality is central to outcomes, making it an ideal setting to test theory-based generative artificial intelligence (GenAI) communication interventions.
Grounded in the Goal-Power Theory of Communication developed by the applicant, this four-year project adopts a mixed-methods design to develop and evaluate a theory-based communication measurement instrument and a GenAI-supported communication aid, NurseChat+. The project comprises three sequential phases: (1) instrument development and validation, (2) intervention development and pilot testing, and (3) clinical evaluation using a randomized controlled trial (RCT). Phase 1 aims to develop and psychometrically validate a theory-based instrument for assessing health communication quality. Instrument development and validation will follow the MEASURE framework, including expert content validation and field testing with approximately 500 participants recruited from clinical settings within the National Taiwan University Hospital system. Phase 2 aims to develop and preliminarily validate the NurseChat+ using a user-centered design approach. A pilot usability and feasibility study will be conducted using a one-group pretest-posttest design with a minimum of 20 healthy adults to assess acceptability, usability, and preliminary effects on communication self-efficacy. Phase 3 will conduct a parallel-group, superiority RCT with an embedded mixed-methods design in palliative care outpatient and home care settings at National Taiwan University Hospital. Eligible adult patients receiving palliative care will be randomly allocated in a 1:1 ratio to the intervention group (NurseChat+ plus usual care) or the control group (usual care alone). The target sample size is 240 participants (120 per group). Intervention participants will use NurseChat+ prior to scheduled medical encounters.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NurseChat+ plus usual care | Experimental | Behavioral: NurseChat+Participants in the experimental group will be invited to interact with NurseChat+ on an iPad provided by the research team before beginning their medical consultation. Successful completion of the intervention is defined as either a minimum of ten minutes of NurseChat+ use or completion of a full round of patient input, data retrieval, and response generation |
| Usual Care | No intervention | –Participants in the control group will receive usual palliative care without access to the NurseChat+ intervention. Usual care includes standard clinical consultations and communication with healthcare providers as provided in routine practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Diagnosed with an advanced disease requiring consultation with outpatient palliative care clinics or home care services.
- Able to self-complete the study questionnaires.
- Age 18 years or older.
- Identified as the primary family caregiver of a patient with an advanced disease requiring palliative care.
Key exclusion criteria (4 listed)
- -None
- Group 2: Caregivers (Proxy-responding) (Invited only when the patient meets the clinical criteria but is unable to self-complete the questionnaires)
- Professional or paid caregivers.
- Unable to complete the study questionnaires.
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 |
|---|---|---|
| NurseChat+Participants will use NurseChat+, a generative AI-supported communication tool, before scheduled palliative care visits to help prepare questions and concerns for discussion with healthcare providers. The intervention is provided in addition to usual care. | Behavioural | NurseChat+ plus usual care |
Primary outcome
Change from Baseline in Communication Self-Efficacy via the 5-item Perceived Efficacy in Patient-Physician Interaction Scale (PEPPI-5)
Time frame: Baseline (T0: within 12 hours prior to the scheduled consultation) and Post-test (T1: immediately following the medical consultation or the interaction with GenAI communication aid).
【Randomized Control Trial \& Pilot study】The PEPPI-5 is a 5-item self-report instrument used to measure a patient's perceived self-efficacy in communicating with their physician. Each item is scored on a 5-point Likert scale from 1 (not at all confident) to 5 (very confident). The total score ranges from 5 to 25, with higher scores indicating higher levels of communication self-efficacy. Outcome will be assessed as the change in scores from T0 to T1.
Quality of Health Communication via the Phase-One Developed Instrument
Time frame: Post-test follow-up (T1: 24-72 hours after the consultation via telephone interview).
Evaluated using a newly developed and validated communication-quality instrument generated in Phase One of the study. This instrument is designed to comprehensively assess the specific communication quality, patterns, and clinical encounter effectiveness between healthcare providers and palliative care patients/families when aided by GenAI communication aid. The instrument is currently undergoing development and psychometric validation. The finalized total score will be structured such that higher scores will mathematically indicate a superior quality of health communication and better communication patterns.
6 secondary outcomes
System Usability Scale (SUS) Score of NurseChat+
Time frame: Post-test (immediately after the interaction with GenAI communication aid).
Inventory of Technology Acceptance Model (ITAM) Score
Time frame: Post-test ( immediately after the interaction with GenAI communication aid)
Evaluation of User Experience via the User Experience Questionnaire (UEQ)
Time frame: Post-test (immediately after the interaction with GenAI communication aid)
Improvement in Symptom Burden via the Edmonton Symptom Assessment System (ESAS)
Time frame: Baseline (T0: within 12 hours prior to the scheduled consultation) and Post-test (T1: post-consultation follow-up within 24-72 hours).
Patient Overall and Communication Satisfaction via the Chinese Patients' Satisfaction Scale (C-PSS)
Time frame: Post-test follow-up (T1: 24-72 hours after the consultation via telephone interview).
Patient Satisfaction with Decision Making via the Satisfaction with Decision (SWD) Scale
Time frame: Post-test follow-up (T1: 24-72 hours after the consultation via telephone interview).
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 14 Jul 2026.
- Individual participant dataSharing planned: No. IPD underlying this study will not be made available to outside researchers. This restriction is necessary to protect patient privacy and to adhere to the informed consent agreements approved by our Institutional Review Board (IRB).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NurseChat+ in people with Palliative Care and Generative Artificial Intelligence, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 inclusion and 4 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 14 Jul 2026. 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 Taiwan. 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?
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 Chia-Chun Tang, PhD (886-905925300, chiatang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Communication Self-Efficacy via the 5-item Perceived Efficacy in Patient-Physician Interaction Scale (PEPPI-5) (time frame: Baseline (T0: within 12 hours prior to the scheduled consultation) and Post-test (T1: immediately following the medical consultation or the interaction with GenAI communication aid).). 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 14 Jul 2026.