The Diabetes Patient-Reported Outcome Measures Trial

NCT03471104 | Withdrawn

• 1 other identifier: 2017-01506
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes-related distress; Living with diabetes; Patient-Reported Outcome Measures (PROMs)

Outcome Measures

Primary Outcomes (1)

• Change in Diabetes Distress Scale (DDS)

  Self reported diabetes-related distress. 17 items are scored on a 6 point Likert scale from 1 "not a problem" to 6 "very serious problem". Scores are summated and divided by 17 to form a mean/average score. There are also four subscales; emotional burden (5 items), physician-related distress (4 items), regimen-related distress (5 items) and interpersonal distress (3 items). The subscale scores are calculated similar to the total score except for dividing by the number of items for each subscale. A total DDS-score or subscale score of more than 3 is regarded as high degree of diabetes distress. Whilst a score of 2 indicate moderate diabetes distress and a score of 1 is considered as low degree of diabetes distress.

  Baseline, 12 months and 24 months.

Secondary Outcomes (3)

• Change in The World Health Organisation 5-wellbeing scale (WHO-5)

  Baseline, 12 months and 24 months.

• Change in Perceived Competence for Diabetes Scale (PCDS)

  Baseline, 12 months and 24 months.

• Change in Glycosylated hemoglobin A1c (HbA1c)

  Baseline, 12 months and 24 months.

Study Arms (2)

PAID in clinical diabetes consultations

EXPERIMENTAL

Participants randomised to the intervention arm. Participants complete the Problem Area in Diabetes scale (PAID) and evaluation PROMs. Participants with specified PAID scores will be offered an empowerment-based follow-up by diabetes specialist nurses.

Other: PAID in clinical diabetes consultations

Control group

NO INTERVENTION

Participants randomised to the control group. Participants complete PROMs but the results/answers will not be available in the electronic patient records until the trial is finished. The participants will receive standard care.

Interventions

PAID in clinical diabetes consultations OTHER

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.

Also known as: DiaPROM

PAID in clinical diabetes consultations

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• type 1 diabetes for more than one year

You may not qualify if:

• not being able to read and complete questionnaires on the computer because of
• language problems
• reading problems
• cognitive problems
• pregnancy
• severe somatic and psychiatric co-morbidities

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Western Norway University of Applied Sciences: collaborator
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, Hordaland, 5021, Norway

Location

Related Publications (3)

• 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.

  PMID: 30782722 BACKGROUND

• 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.

  PMID: 33853796 BACKGROUND

• 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.

  PMID: 33547702 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Anne Haugstvedt, PhD

  Haukeland UH

  PRINCIPAL INVESTIGATOR

• Marit Graue, PhD

  Western Norway University of Applied Sciences

  STUDY CHAIR

• Ragnhild B. Strandberg, PhD

  Western Norway University of Applied Sciences

  STUDY CHAIR

• Grethe S. Tell, PhD

  University of Bergen

  STUDY CHAIR

• Ingvild Hernar, MSc

  University of Bergen, Haukeland UH, Western Norway Uni. of Applied Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 20, 2018
• Study Start: January 15, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: May 13, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)