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Diabetes Mellitus, Type 1DiaPROMNCT03471104

The Diabetes Patient-Reported Outcome Measures Trial

A study testing PAID in clinical diabetes consultations in people with Diabetes Mellitus, Type 1, run by Haukeland University Hospital at 1 site in Norway.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 39 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
PAID in clinical diabetes consultations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteNorway
Study dates
15 Jan 2018to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • All sexes
  • No healthy volunteers
  • Adult
  1. Inclusion Criteria:
  • type 1 diabetes for more than one year
  1. Exclusion Criteria:
  2. not being able to read and complete questionnaires on the computer because of
  • language problems
  • reading problems
  • cognitive problems
  1. pregnancy
  2. severe somatic and psychiatric co-morbidities

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Haukeland University Hospital

    Bergen, Hordaland, 5021

Other trials in Norway

About this study

Official title: 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.

Read the 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.

Being tested
PAID in clinical diabetes consultations
Keywords
Diabetes-related distress, Living with diabetes, Patient-Reported Outcome Measures (PROMs)
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PAID in clinical diabetes consultationsOther

    Also called DiaPROM

    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.

Study groups in NCT03471104
Study groupRoleWhat they receive
PAID in clinical diabetes consultationsExperimentalParticipants 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.
Receives: Other: PAID in clinical diabetes consultations
Control groupNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 12 months and 24 months.

Secondary outcomes (3)

  1. 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.

    Measured: Baseline, 12 months and 24 months.

  2. 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.

    Measured: Baseline, 12 months and 24 months.

  3. Change in Glycosylated hemoglobin A1c (HbA1c)

    Blood test: HbA1c refers to glycated hemoglobin, which identifies average plasma glucose concentration. Higher values indicate worse outcome.

    Measured: Baseline, 12 months and 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2018
  2. Study start15 Jan 2018
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Why it stopped: We have piloted the trial and concluded not to proceed to a fullscale trial.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03471104
Sponsor's protocol ID
2017-01506
Other IDs
2017
Acronym
DiaPROM
Status last verified
Oct 2020
First submitted
22 Feb 2018
Last updated
13 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Haugstvedt A, Hernar I, Strandberg RB, Richards DA, Nilsen RM, Tell GS, Graue M. Use of patient-reported outcome measures (PROMs) in clinical diabetes consultations: study protocol for the DiaPROM randomised controlled trial pilot study. BMJ Open. 2019 Jan 17;9(1):e024008. doi: 10.1136/bmjopen-2018-024008.

    PubMed 30782722

  • Hernar I, Graue M, Richards DA, Strandberg RB, Nilsen RM, Rekdal M, Lovaas KF, Madsen TV, Tell GS, Haugstvedt A. Use of patient-reported outcome measures (PROMs) in clinical diabetes consultations: the DiaPROM randomised controlled pilot trial. BMJ Open. 2021 Apr 14;11(4):e042353. doi: 10.1136/bmjopen-2020-042353.

    PubMed 33853796

  • Hernar I, Graue M, Strandberg RB, Lie SS, Sigurdardottir AK, Richards DA, Kolltveit BH, Haugstvedt A. Young adults with type 1 diabetes and their experiences with diabetes follow-up and participation in the DiaPROM pilot trial: A qualitative study. Diabet Med. 2021 Jun;38(6):e14535. doi: 10.1111/dme.14535. Epub 2021 Feb 16.

    PubMed 33547702

Questions about this trial

What is this clinical trial studying?

A study testing PAID in clinical diabetes consultations in people with Diabetes Mellitus, Type 1, run by Haukeland University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Diabetes Distress Scale (DDS) (time frame: Baseline, 12 months and 24 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03471104, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.

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