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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
344
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.
Aahurs University Hospital
Aarhus, Denmark
HbA1c
Non-inferiority with respect to HbA1c
Time frame: 15 mounth
General health will be assessed by items from the SF-36 questionnaire
General health will be measured at baseline and after 15 mounth
Time frame: 15 mounth
Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 6 and 9)
Health literacy will be measured at baseline and after 15 months.
Time frame: 15 mounth
Well-being will be assessed by the WHO-5 Well-being Index
Well-being will be measured at baseline and after 15 months.
Time frame: 15 mounth
Patient Activated Measure (PAM)
Patient Activated Measure (PAM) will be measured at baseline and after 15 months.
Time frame: 15 mounth
"Generic questions concerning patient involvement" is validate by "DEFACTUM"
Patient involvement will be measured at baseline and after 15 months.
Time frame: 15 mounth
The problem Areas In Diabetes Scale (PAID)
PAID will be measured at baseline and after 15 months.
Time frame: 15 mounth
Blood pressure
Blood pressure will be measured at baseline and after 15 months.
Time frame: 15 mounth
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Urine albumine/creatinine ratio
urine albumine/creatinine ratio will be measured at baseline and after 15 months.
Time frame: 15 mounth
Number and type consultations
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
Time frame: 15 mounth
Mortality
Mortality will be measured after 15 months.
Time frame: 15 mounth