Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT03202732
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Annesofie Lunde Jensen, Aarhus University Hospital

Tracking Information
First Submitted Date  ICMJE June 27, 2017
First Posted Date  ICMJE June 29, 2017
Last Update Posted Date February 12, 2019
Actual Study Start Date  ICMJE October 9, 2017
Estimated Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2017)		 HbA1c [ Time Frame: 15 mounth ]
Non-inferiority with respect to HbA1c
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03202732 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2017)
  • 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
  • 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.
  • 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.
  • Patient Activated Measure (PAM) [ Time Frame: 15 mounth ]
    Patient Activated Measure (PAM) will be measured at baseline and after 15 months.
  • "Generic questions concerning patient involvement" is validate by "DEFACTUM" [ Time Frame: 15 mounth ]
    Patient involvement will be measured at baseline and after 15 months.
  • The problem Areas In Diabetes Scale (PAID) [ Time Frame: 15 mounth ]
    PAID will be measured at baseline and after 15 months.
  • Blood pressure [ Time Frame: 15 mounth ]
    Blood pressure will be measured at baseline and after 15 months.
  • Urine albumine/creatinine ratio [ Time Frame: 15 mounth ]
    urine albumine/creatinine ratio will be measured at baseline and after 15 months.
  • 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
  • Mortality [ Time Frame: 15 mounth ]
    Mortality will be measured after 15 months.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes
Official Title  ICMJE DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes: A Randomised Controlled Trial and Interview Study
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Type1 Diabetes Mellitus
Intervention  ICMJE 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: www.diabetesflex.auh.dk.
Study Arms  ICMJE
  • DiabetesFlex

    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.

    Intervention: Other: DiabetesFlex
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2017)		 400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2021
Estimated Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 www.sundhed.dk Be mentally well functioning Understand and read Danish Access to internet
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Annesofie L. Jensen, Postdoc +45 20 47 02 60 anejns@rm.dk
Contact: Troels K. Hansen, Professor +45 78 46 22 39 troeha@rm.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03202732
Other Study ID Numbers  ICMJE DiabetesFlex2017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Annesofie Lunde Jensen, Aarhus University Hospital
Study Sponsor  ICMJE Annesofie Lunde Jensen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Annesofie L. Jensen, Postdoc Aarhus University Hospital
PRS Account Aarhus University Hospital
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP