Diabetes Mellitus, Type 1
Conditions
Keywords
Diabetes-related distress, Living with diabetes, Patient-Reported Outcome Measures (PROMs)
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.
Interventions
OTHERPAID 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.
Sponsors
Western Norway University of Applied Sciences
University of Bergen
Haukeland University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Countries
Norway
Outcome results
None listed