Ignite Creation Date:
2025-12-24 @ 7:54 PM
Ignite Modification Date:
2025-12-25 @ 5:30 PM
Study NCT ID:
NCT03471104
Status:
WITHDRAWN
Last Update Posted:
2021-05-13
First Post:
2018-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Diabetes Patient-Reported Outcome Measures Trial
Sponsor:
Haukeland University Hospital
Organization:
Study Overview
Official Title:
The Use of Patient-Reported Outcome Measures (PROMs) to Promote Quality of Clinical Diabetes Consultations
Status:
WITHDRAWN
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We have piloted the trial and concluded not to proceed to a fullscale trial.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DiaPROM
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: