Clinical trial NCT03471104: The Diabetes Patient-Reported Outcome Measures Trial
Official title: The Use of Patient-Reported Outcome Measures (PROMs) to Promote Quality of Clinical Diabetes Consultations
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes-related distress
Living with diabetes
Patient-Reported Outcome Measures (PROMs)
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Western Norway University of Applied Sciences
name: University of Bergen
First posted: 2018-03-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.

Eligibility criteria: 1. Inclusion Criteria:

   * type 1 diabetes for more than one year
2. Exclusion Criteria:

   1. not being able to read and complete questionnaires on the computer because of

      * language problems
      * reading problems
      * cognitive problems
   2. pregnancy
   3. severe somatic and psychiatric co-morbidities

Primary outcomes:
measure: Change in Diabetes Distress Scale (DDS)
timeFrame: Baseline, 12 months and 24 months.
Secondary outcomes:
measure: Change in The World Health Organisation 5-wellbeing scale (WHO-5)
timeFrame: Baseline, 12 months and 24 months.
measure: Change in Perceived Competence for Diabetes Scale (PCDS)
timeFrame: Baseline, 12 months and 24 months.
measure: Change in Glycosylated hemoglobin A1c (HbA1c)
timeFrame: Baseline, 12 months and 24 months.
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: Hordaland
Study officials:
affiliation: Haukeland UH
name: Anne Haugstvedt, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Norway University of Applied Sciences
name: Marit Graue, PhD
role: STUDY_CHAIR
affiliation: Western Norway University of Applied Sciences
name: Ragnhild B. Strandberg, PhD
role: STUDY_CHAIR
affiliation: University of Bergen
name: Grethe S. Tell, PhD
role: STUDY_CHAIR
affiliation: University of Bergen, Haukeland UH, Western Norway Uni. of Applied Sciences
name: Ingvild Hernar, MSc
role: STUDY_CHAIR
References:
citation: Haugstvedt A, Hernar I, Strandberg RB, Richards DA, Nilsen RM, Tell GS, Graue M. Use of patient-reported outcome measures (PROMs) in clinical diabetes consultations: study protocol for the DiaPROM randomised controlled trial pilot study. BMJ Open. 2019 Jan 17;9(1):e024008. doi: 10.1136/bmjopen-2018-024008.
citation: Hernar I, Graue M, Richards DA, Strandberg RB, Nilsen RM, Rekdal M, Lovaas KF, Madsen TV, Tell GS, Haugstvedt A. Use of patient-reported outcome measures (PROMs) in clinical diabetes consultations: the DiaPROM randomised controlled pilot trial. BMJ Open. 2021 Apr 14;11(4):e042353. doi: 10.1136/bmjopen-2020-042353.
citation: Hernar I, Graue M, Strandberg RB, Lie SS, Sigurdardottir AK, Richards DA, Kolltveit BH, Haugstvedt A. Young adults with type 1 diabetes and their experiences with diabetes follow-up and participation in the DiaPROM pilot trial: A qualitative study. Diabet Med. 2021 Jun;38(6):e14535. doi: 10.1111/dme.14535. Epub 2021 Feb 16.