The Diabetes Patient-Reported Outcome Measures Trial (DiaPROM)

May 11, 2021 updated by: Haukeland University Hospital

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Hordaland
      • Bergen, Hordaland, Norway, 5021
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.

Other Names:
  • DiaPROM
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Diabetes Distress Scale (DDS)
Time Frame: 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.
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)
Time Frame: 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.
Baseline, 12 months and 24 months.
Change in Perceived Competence for Diabetes Scale (PCDS)
Time Frame: 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.
Baseline, 12 months and 24 months.
Change in Glycosylated hemoglobin A1c (HbA1c)
Time Frame: Baseline, 12 months and 24 months.
Blood test: HbA1c refers to glycated hemoglobin, which identifies average plasma glucose concentration. Higher values indicate worse outcome.
Baseline, 12 months and 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Collaborators

University of Bergen
Western Norway University of Applied Sciences

Investigators

  • Principal Investigator: Anne Haugstvedt, PhD, Haukeland UH
  • Study Chair: Marit Graue, PhD, Western Norway University of Applied Sciences
  • Study Chair: Ragnhild B. Strandberg, PhD, Western Norway University of Applied Sciences
  • Study Chair: Grethe S. Tell, PhD, University of Bergen
  • Study Chair: Ingvild Hernar, MSc, University of Bergen, Haukeland UH, Western Norway Uni. of Applied Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2018

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

March 19, 2018

First Posted (Actual)

March 20, 2018

Study Record Updates

Last Update Posted (Actual)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-01506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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