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

NCT ID: NCT03202732

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

344 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-09

Study Completion Date

2020-08-25

Brief Summary

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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

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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.

Conditions

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Type1 Diabetes Mellitus

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

DiabetesFlex

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Annesofie Lunde Jensen

OTHER

Sponsor Role lead

Responsible Party

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Annesofie Lunde Jensen

Clinical nursespecialist postdoc

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Annesofie L. Jensen, Postdoc

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aahurs University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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DiabetesFlex2017

Identifier Type: -

Identifier Source: org_study_id