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DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03202732
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : February 12, 2019
Information provided by (Responsible Party):
Annesofie Lunde Jensen, Aarhus University Hospital

Brief Summary:

The aim of this study is to investigate the effect of the use of DiabetesFlex in diabetes care compared to standard care in relation to patient involvement and relevance for specific group of persons with T1DM.

The investigators hypothesize that the use of DiabetesFlex will lead to a higher degree of patient in-volvement, improved glycaemic control and a decrease in total number of consultations compared to standard care. Furthermore, the investigators aim to identify if a specific sub-population within the T1DM population will benefit significantly from the intervention.

Condition or disease Intervention/treatment Phase
Type1 Diabetes Mellitus Other: DiabetesFlex Not Applicable

Detailed Description:

Diabetes Mellitus (DM) is a chronic condition, and provision of individual and effective diabetes care is a major challenge. The is a lack of evidence on the optimal frequency of attending outpatient clinics for persons with T1DM.

The use of patient-reported outcome (PRO) measures in diabetes care area are limited and none existing in a Danish context. This includes studies, which combine PRO measure with diabetes management, patient involvement and self-management.

The study will generate knowledge and directions for ways to reframe and to optimize the future management of diabetes care.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes: A Randomised Controlled Trial and Interview Study
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : February 20, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment

In DiabetesFlex intervention, patients are offered 3 consultations/year. One mandatory consultations (30 minutes). The patient, an endocrinologist and a diabetes nurse attend.

Two optional consultations, patients can choose between face-to-face consultations, a telephone consultation or to cancel the consultation.

Ahead of the consultations, patients fill out the AmbuFlex Diabetes questionnaire and deliver a blood and urine sample.

Based on the patient's response to the AmbuFlex Diabetes questionnaire, the result of the blood sample and the urine sample, the diabetes nurse assign the patient to a face-to-face consultation, a telephone consultation or no consultation with an endocrinologist, a diabetes nurse or a dietician.

Other: DiabetesFlex

DiabetesFlex consist of one mandatory and two optional consultations. Before the consultations patients receive the AmbuFlex Diabetes questionnaire.

The AmbuFlex Diabetes questionnaire is based on both validated questionnaires and clinical consensus. The AmbuFlex Diabetes questionnaire consists of: SF36 well-being question, WHO-5 Well-being Index. Questions concerning: HgA1c, home-based blood pressure monitoring, incidents of hypoglycemia, diabetes complications, regular eye check, regular food check, erectile dysfunction and peripheral neuropathy, The PAID scale, Topics patients may want to talk with the health care professional about, the patient's evaluation of the need for diabetes care. View the AmbuFlex Diabetes questionnaire at the homepage:

No Intervention: Standard care

Standard diabetes care consists of 3 consultations (15 minutes)/year with a physician or a diabetes nurse by turns.

Ahead of the consultation patients send in a blood sample for measuring HgA1c, urine sample for measuring urin-albumin creatinin ratio and other blood samples depending of arrangements made in the last consultation.

Once a year in relation to a consultation, patients fill in the Problem Area In Diabetes (PAID) (20) scale together. Furthermore, based on the patients or healthcare professional judgement, patients see a dietician when needed.

Primary Outcome Measures :
  1. HbA1c [ Time Frame: 15 mounth ]
    Non-inferiority with respect to HbA1c

Secondary Outcome Measures :
  1. General health will be assessed by items from the SF-36 questionnaire [ Time Frame: 15 mounth ]
    General health will be measured at baseline and after 15 mounth

  2. Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 6 and 9) [ Time Frame: 15 mounth ]
    Health literacy will be measured at baseline and after 15 months.

  3. Well-being will be assessed by the WHO-5 Well-being Index [ Time Frame: 15 mounth ]
    Well-being will be measured at baseline and after 15 months.

  4. Patient Activated Measure (PAM) [ Time Frame: 15 mounth ]
    Patient Activated Measure (PAM) will be measured at baseline and after 15 months.

  5. "Generic questions concerning patient involvement" is validate by "DEFACTUM" [ Time Frame: 15 mounth ]
    Patient involvement will be measured at baseline and after 15 months.

  6. The problem Areas In Diabetes Scale (PAID) [ Time Frame: 15 mounth ]
    PAID will be measured at baseline and after 15 months.

  7. Blood pressure [ Time Frame: 15 mounth ]
    Blood pressure will be measured at baseline and after 15 months.

  8. Urine albumine/creatinine ratio [ Time Frame: 15 mounth ]
    urine albumine/creatinine ratio will be measured at baseline and after 15 months.

  9. Number and type consultations [ Time Frame: 15 mounth ]
    Consultations consists of face-to-face, telephone, cancel, registered non-attendance and health care professional involved in the consultation will be measured after 15 mounth

  10. Mortality [ Time Frame: 15 mounth ]
    Mortality will be measured after 15 months.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Age over 18 years Have had T1DM for more than 2 years Be able to use the Danish-language general website on healthcare Be mentally well functioning Understand and read Danish Access to internet

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 identifier (NCT number): NCT03202732

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Contact: Annesofie L. Jensen, Postdoc +45 20 47 02 60
Contact: Troels K. Hansen, Professor +45 78 46 22 39

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Aahurs University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Annesofie L. Jenesen, Postdoc    +45 20 47 02 60   
Contact: Troels K. Hansen, Professor    +45 7 46 22 39   
Sponsors and Collaborators
Annesofie Lunde Jensen
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Principal Investigator: Annesofie L. Jensen, Postdoc Aarhus University Hospital

Additional Information:
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Responsible Party: Annesofie Lunde Jensen, Clinical nursespecialist postdoc, Aarhus University Hospital Identifier: NCT03202732    
Other Study ID Numbers: DiabetesFlex2017
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
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 Annesofie Lunde Jensen, Aarhus University Hospital:
Patient Activeted measure
Patient-reported outcome
Type 1 diabetes Mellitus
Non-inferiority study
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