The Diabetes Patient-Reported Outcome Measures Trial

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

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Other: PAID in clinical diabetes consultations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 1 diabetes for more than one year Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAID in clinical diabetes consultations<br>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<br>* 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.<br>* Other names: DiaPROM;|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes-related distress, Living with diabetes, Patient-Reported Outcome Measures (PROMs)