The Diabetes Patient-Reported Outcome Measures Trial (DiaPROM)
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|ClinicalTrials.gov Identifier: NCT03471104|
Recruitment Status : Not yet recruiting
First Posted : March 20, 2018
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Other: PAID in clinical diabetes consultations||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Patient-Reported Outcome Measures (PROMs) to Promote Quality of Clinical Diabetes Consultations.|
|Estimated Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||September 1, 2022|
|Estimated Study Completion Date :||December 31, 2023|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Anne Haugstvedt, PhD||47829220 ext email@example.com|
|Contact: Ingvild Hernar, MSc||90683641 ext firstname.lastname@example.org|
|Haukeland University Hospital||Not yet recruiting|
|Bergen, Hordaland, Norway, 5021|
|Contact: Lars Birger Nesje, MD 95890417 ext 0047 email@example.com|
|Sub-Investigator: Ingvild Hernar, MSc|
|Principal Investigator: Anne Haugstvedt, PhD|
|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|