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

NCT03202732 | Completed DMC

• 1 other identifier: DiabetesFlex2017
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1 Diabetes Mellitus

Keywords

Self-management; Patient Activeted measure; Patient-reported outcome; Type 1 diabetes Mellitus; Non-inferiority study

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Non-inferiority with respect to HbA1c

  15 mounth

Secondary Outcomes (10)

• General health will be assessed by items from the SF-36 questionnaire

  15 mounth

• Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 6 and 9)

  15 mounth

• Well-being will be assessed by the WHO-5 Well-being Index

  15 mounth

• Patient Activated Measure (PAM)

  15 mounth

• "Generic questions concerning patient involvement" is validate by "DEFACTUM"

  15 mounth

Study Arms (2)

DiabetesFlex

OTHER

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

Standard care

NO INTERVENTION

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.

Interventions

DiabetesFlex OTHER

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.

DiabetesFlex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Annesofie Lunde Jensen: lead

Study Sites (1)

Aahurs University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Annesofie L. Jensen, Postdoc

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical nursespecialist postdoc

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 29, 2017
• Study Start: October 9, 2017
• Primary Completion: August 20, 2020
• Study Completion: August 25, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)