NCT03471104

The Diabetes Patient-Reported Outcome Measures Trial

The Use of Patient-Reported Outcome Measures (PROMs) to Promote Quality of Clinical Diabetes Consultations

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

The study aim to evaluate the use of Patient-Reported Outcome Measures in clinical diabetes consultations.

Detailed description

The psychological and emotional impact of living with diabetes is greatly underreported in clinical diabetes care, and diabetes distress is found to be associated with decreased glycemic control. Therefore, regular assessment of diabetes distress is recommended. The integration of assessments with Patient-Reported Outcome Measures (PROMs) in clinical practice has the potential to enhance care for people with diabetes by identifying problems and improving patient-clinician communication. The overall aim of the DiaPROM trial is to develop, test and evaluate the effectiveness of a structured empowerment-based intervention with the use of a PROM regarding diabetes distress as a tool for needs assessment and dialogue support in clinical diabetes consultations among adults with Type 1 Diabetes. The investigator's hypothesis is that the intervention primarily will reduce diabetes distress and secondarily improve overall well-being, improve the perceived competence for diabetes management, improve glycemic control, and improve satisfaction with the diabetes follow-up.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
OTHER	PAID in clinical diabetes consultations	The intervention starts when participants complete PROMs before an annual consultation. The physician reviews the PAID (problem areas in diabetes scale) scores with the participant. Participants with one or more single PAID item(s) scored 3 or 4, or a PAID score ≥30, will be referred to extra follow-up which will consist of at least two diabetes nurse consultations. The nurses will follow a communication manual based on key elements from empowerment theory and self-determination theory. The participants then complete the PROMs prior to the next annual consultation with the physician.

Timeline

• Start date: 2018-01-15
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2018-03-20
• Last updated: 2021-05-13

Locations

1 site across 1 country: Norway