The Diabetes Patient-Reported Outcome Measures Trial

Not Applicable

Withdrawn

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: PAID in clinical diabetes consultations

• Registration Number: NCT03471104
• Lead Sponsor: Haukeland University Hospital

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 Timeline

• Study Start: 2018-01-15
• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-20
• Status Verified: 2020-10
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-05-13
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• type 1 diabetes for more than one year

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PAID in clinical diabetes consultations	PAID in clinical diabetes consultations	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.

Primary Outcome Measures

Name	Time	Method
Change in Diabetes Distress Scale (DDS)	Baseline, 12 months and 24 months.	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.

Secondary Outcome Measures

Name	Time	Method
Change in The World Health Organisation 5-wellbeing scale (WHO-5)	Baseline, 12 months and 24 months.	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.
Change in Glycosylated hemoglobin A1c (HbA1c)	Baseline, 12 months and 24 months.	Blood test: HbA1c refers to glycated hemoglobin, which identifies average plasma glucose concentration. Higher values indicate worse outcome.
Change in Perceived Competence for Diabetes Scale (PCDS)	Baseline, 12 months and 24 months.	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.

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Hordaland, Norway