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PREMs on PROMs in Breast Disease (PREMs_PROMs)

NCT04718324 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2021-05-17

No results posted yet for this study

Summary

In recent years, large interest in the conduct and focus of clinical trials has focused to patient related outcomes and value-based healthcare. Patient Reported Outcome MeasureS, (PROMs) has become one of the standard instruments used for measuring outcomes; multiple PROMS have been extensively validated and are used in many clinical studies, but also in clinical routine. Additionally, Patient Reported Experience MeasureS (PREMS) allow for real-time feedback on the integration of care and can subsequently drive changes in health provision systems. In the present trial, the mode of delivery of PROMS is examined in terms of effectivity and patient experience (PREMS) in the setting of breast disease.

Conditions

Interventions

OTHER

e-PROMS

Participants randomised to the e-PROMS arm will receive a safe link to the e-PROMS and a unique identification number in the electronic form, so as to preserve anonymity. This is a one-time intervention

OTHER

p-PROMS

Participants randomised to the p-PROMS arm will receive the PROMS and PREMS questionnaires and a unique identification number in paper form.

Sponsors & Collaborators

  • Uppsala University

    lead OTHER

Principal Investigators

  • Andreas Karakatsanis, PhD · Uppsala University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-03-30
Completion
2021-04-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04718324 on ClinicalTrials.gov