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

• ClinicalTrials.gov Identifier: NCT03202732
• Recruitment Status: Completed
• First Posted: June 29, 2017
• Last Update Posted: November 6, 2020
• Sponsor: Annesofie Lunde Jensen
• Information provided by (Responsible Party): Annesofie Lunde Jensen, Aarhus University Hospital

Tracking Information

• First Submitted Date: June 27, 2017
• First Posted Date: June 29, 2017
• Last Update Posted Date: November 6, 2020
• Actual Study Start Date: October 9, 2017
• Actual Primary Completion Date: August 20, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 27, 2017)

HbA1c [ Time Frame: 15 mounth ]

Non-inferiority with respect to HbA1c

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Type1 Diabetes Mellitus

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 15, 2020): 344
• Original Estimated Enrollment (submitted: June 27, 2017): 400
• Actual Study Completion Date: August 25, 2020
• Actual Primary Completion Date: August 20, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Age over 18 years Have had T1DM for more than 1 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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT03202732
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Annesofie Lunde Jensen, Aarhus University Hospital
• Study Sponsor: Annesofie Lunde Jensen
• Collaborators: Not Provided

Investigators

• Principal Investigator: Annesofie L. Jensen, Postdoc; Aarhus University Hospital

• PRS Account: Aarhus University Hospital
• Verification Date: November 2020