The Diabetes Patient-Reported Outcome Measures Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2023-12-31

Brief Summary

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

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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.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PAID in clinical diabetes consultations

Intervention Type OTHER

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.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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DiaPROM

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No