Clinical trial NCT03202732: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1 Diabetes Mellitus
Keywords: Self-management
Patient Activeted measure
Patient-reported outcome
Type 1 diabetes Mellitus
Non-inferiority study
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: HbA1c
timeFrame: 15 mounth
Secondary outcomes:
measure: General health will be assessed by items from the SF-36 questionnaire
timeFrame: 15 mounth
measure: Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 6 and 9)
timeFrame: 15 mounth
measure: Well-being will be assessed by the WHO-5 Well-being Index
timeFrame: 15 mounth
measure: Patient Activated Measure (PAM)
timeFrame: 15 mounth
measure: "Generic questions concerning patient involvement" is validate by "DEFACTUM"
timeFrame: 15 mounth
measure: The problem Areas In Diabetes Scale (PAID)
timeFrame: 15 mounth
measure: Blood pressure
timeFrame: 15 mounth
measure: Urine albumine/creatinine ratio
timeFrame: 15 mounth
measure: Number and type consultations
timeFrame: 15 mounth
measure: Mortality
timeFrame: 15 mounth
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aahurs University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Annesofie L. Jensen, Postdoc
role: PRINCIPAL_INVESTIGATOR
References: