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The Diabetes Patient-Reported Outcome Measures Trial

NCT03471104 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-05-13

No results posted yet for this study

Summary

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

Conditions

  • Diabetes Mellitus, Type 1

Interventions

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.

Sponsors & Collaborators

  • Western Norway University of Applied Sciences

    collaborator OTHER

  • University of Bergen

    collaborator OTHER

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Anne Haugstvedt, PhD · Haukeland UH

  • Marit Graue, PhD · Western Norway University of Applied Sciences

  • Ragnhild B. Strandberg, PhD · Western Norway University of Applied Sciences

  • Grethe S. Tell, PhD · University of Bergen

  • Ingvild Hernar, MSc · University of Bergen, Haukeland UH, Western Norway Uni. of Applied Sciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • Norway

Study Locations

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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 NCT03471104 on ClinicalTrials.gov