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Trial record 5 of 981 for:    scale | Norway

Patient-Reported Outcome Measures in Diabetes Care (DiaPROM)

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ClinicalTrials.gov Identifier: NCT03471104
Recruitment Status : Not yet recruiting
First Posted : March 20, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
Western Norway University of Applied Sciences
University of Bergen
Information provided by (Responsible Party):
Haukeland University Hospital

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Other: PAID in clinical diabetes consultations Not Applicable

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. Our 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Use of Patient-Reported Outcome Measures (PROMs) to Promote Quality of Clinical Diabetes Consultations.
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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 Name: 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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Change in The Problem Area In Diabetes scale [ Time Frame: Baseline, 12 months and 24 months. ]
    Self reported diabetes-related distress. 20 items are scored on 5 point Likert scale from 0 "not a problem" to 4 "serious problem". Scores are summated. The raw score 0 to 80 is transformed to 0-100 by multiplying by 1.25. (This measure is used as the tool for needs assessment and dialogue support in the diabetes nurse specialist consultations.) Higher scores indicate worse outcome. A total score of 40 or more is considered as high degree of diabetes distress.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471104


Contacts
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Contact: Anne Haugstvedt, PhD 47829220 ext 0047 anne.haugstvedt@hvl.no
Contact: Ingvild Hernar, MSc 90683641 ext 0047 ingvild.hernar@helse-bergen.no

Locations
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Norway
Haukeland University Hospital Recruiting
Bergen, Hordaland, Norway, 5021
Contact: Lars Birger Nesje, MD    95890417 ext 0047    lars.birger.nesje@helse-bergen.no   
Sub-Investigator: Ingvild Hernar, MSc         
Principal Investigator: Anne Haugstvedt, PhD         
Sponsors and Collaborators
Haukeland University Hospital
Western Norway University of Applied Sciences
University of Bergen
Investigators
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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 Tell, PhD University of Bergen
Study Chair: Ingvild Hernar, MSc University of Bergen, Haukeland University Hospital, Western Norway University of Applied Sciences
  Study Documents (Full-Text)

Documents provided by Haukeland University Hospital:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03471104     History of Changes
Other Study ID Numbers: 2017-01506
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haukeland University Hospital:
Diabetes-related distress
Living with diabetes
Patient-Reported Outcome Measures (PROMs)

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases