Better Communication, Better Care Using SICG Assistant Based on Artificial Intelligence (NCT07753668) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Better Communication, Better Care Using SICG Assistant Based on Artificial Intelligence
Spain190 participantsStarted 2026-01-01
Plain-language summary
The project 'Better Communication, Better Care' has as its main objective to evaluate the effectiveness of the implementation of the 'Guide to conversation in serious illness (SICG)' by means of a significant reduction in anxiety and depression index in patients with serious illness and their families. Additionally, it aims to explore the perceived utility of this guide from the perspective of patients, families, and healthcare professionals involved in Palliative Care. Another important objective is to assess the effectiveness of the training program to improve communicative competencies of healthcare professionals in real clinical contexts. Furthermore, the project is structured around a pragmatic randomized clinical trial by clusters, where healthcare professionals will be randomized into intervention and control groups, with patients being the unit of analysis. In parallel, a feasibility and usability study of the mobile application and virtual assistant that will support the implementation of the guide will be conducted, evaluating parameters such as learning facility, satisfaction, efficiency, and errors through validated instruments. Finally, a cost-benefit analysis will be carried out to determine the economic efficiency of the program in terms of resource optimization and improvement in care quality.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18-80 years.
* Diagnosis of a serious illness, defined as an illness carrying a high risk of mortality that negatively impacts quality of life or daily functioning, and that typically causes significant emotional distress in caregivers.
* Karnofsky Performance Status ≥ 50 or Performance Status ≤ 2 or Palliative Performance Scale ≥ 50.
* Spanish as native/fluent language, sufficient to complete the study questionnaires.
* Cared for by an HCP enrolled in the study (intervention or control arm).
* Able and willing to provide written informed consent.
Exclusion Criteria:
* Cognitive or perceptual impairment that prevents reliable completion of the study questionnaires.
* Inability to communicate in Spanish to the level required by the assessment instruments.
* Any condition that, in the investigator's judgment, makes participation unsafe or unfeasible (e.g., clinical instability incompatible with follow-up).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in patient anxiety and depression
Timeframe: Baseline, 1 month, 3 months, and 6 months after SICG conversation (or equivalent index visit in the control arm).