The Diabetes Patient-Reported Outcome Measures Trial (DiaPROM)

Haukeland University Hospital

Status: Withdrawn

Conditions: Diabetes Mellitus, Type 1

Treatments: Other: PAID in clinical diabetes consultations

Study type: Interventional

Funder types: Other

Identifiers

NCT03471104

2017-01506

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

PAID in clinical diabetes consultations

Experimental group

Description:

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.

Treatment:

Other: PAID in clinical diabetes consultations

Control group

No Intervention group

Description:

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.