NCT06272552 Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact
| NCT ID | NCT06272552 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Parc de Salut Mar |
| Condition | PROMs |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,440 participants |
| Start Date | 2023-10-25 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,440 participants in total. It began in 2023-10-25 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
There has been increasing interest in the use of patient-reported outcomes and experience measures (PROMs and PREMs) in clinical practice; yet few empirical studies have been conducted to evaluate the usefulness of such implementation. Objective: To evaluate the efficacy of the implementation of PROMs and PREMs in routine clinical care for improving health outcomes and satisfaction with health management. Design: Randomized control trial. Setting: In and outpatient departments of a public hospital in Spain. Participants: 1,440 adult patients managed for breast cancer, prostate cancer, chronic kidney disease, or bariatric surgery. Intervention: Patients will monthly complete, through an App from their smartphones, PROMs and PREMs (arm A, n=480), or only PREMs (arm B, n=480). Responses to PROMs will be transformed into a graphic summary, accessible for physicians and patients at the follow-up visits of the project (9 and 18 months after recruitment). Main outcome measures: Comparison of change among arms on the assessment variables - such as health-related quality of life (EQ-5D-5L), satisfaction with care, or patient-professionals communication. These constructs will be measured at recruitment and at follow up visits for all patients, regardless of their arm allocation (arm C would only be administered these questionnaires, without intervention, n=480). Expected results: Incorporating PROMs and PREMs in routine clinical care may improve patients\' and health professionals\' experiences on health care, as well as improve patients\' health.
Eligibility Criteria
Inclusion Criteria: * Being an active patient of the nephrology service, prostate cancer service, breast cancer service, or bariatric surgery service * In possession of an email account and having basic knowledge of how to manage emails * In possession of a smartphone, computer, or tablet with access to the Internet * Fluent and able to read in Spanish Exclusion Criteria: \- Under 18 years of age
Contact & Investigator
Olatz Garin, PhD
PRINCIPAL INVESTIGATOR
Hospital del Mar Research Institute (IMIM)
Frequently Asked Questions
Who can join the NCT06272552 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PROMs. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06272552 currently recruiting?
Yes, NCT06272552 is actively recruiting participants. Contact the research team at ogarin@researchmar.net for enrollment information.
Where is the NCT06272552 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06272552 clinical trial?
NCT06272552 is sponsored by Parc de Salut Mar. The principal investigator is Olatz Garin, PhD at Hospital del Mar Research Institute (IMIM). The trial plans to enroll 1,440 participants.