The Diabetes Patient-Reported Outcome Measures Trial

Diabetes Mellitus, Type 1 Clinical Trial

— DiaPROM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03471104
• Other study ID #: 2017-01506
• Status: Withdrawn
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2020
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen	Hordaland

Sponsors (3)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen, Western Norway University of Applied Sciences

Country where clinical trial is conducted

Norway, 

References & 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. — View Citation

Hernar I, Graue M, Richards DA, Strandberg RB, Nilsen RM, Rekdal M, Løvaas 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. — View 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 Feb 5:e14535. doi: 10.1111/dme.14535. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in The World Health Organisation 5-wellbeing scale (WHO-5)	Self reported emotional wellbeing. 5 items are scored on a 6 point Likert scale from 0 "never" to 5 "all of the time". Scores are summated. Raw score 0 to 25 is transformed to 0-100 by multiplying by 4. Higher values represent better outcome. A score of 50 or below is indicate suboptimal well-being. A score of 28 or below is considered as likely depression.	Baseline, 12 months and 24 months.
Secondary	Change in Perceived Competence for Diabetes Scale (PCDS)	Self report of the individuals perceptions of competence for diabetes. 4 items are scored on a 7 point Likert scale from 1 "strongly disagree" to 7 "strongly agree". Scores are summated and divided by 4 to form a mean/average score. Higher score indicate better perceived diabetes competence.	Baseline, 12 months and 24 months.
Secondary	Change in Glycosylated hemoglobin A1c (HbA1c)	Blood test: HbA1c refers to glycated hemoglobin, which identifies average plasma glucose concentration. Higher values indicate worse outcome.	Baseline, 12 months and 24 months.