DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes
- Conditions
- Type1 Diabetes Mellitus
- Interventions
- Other: DiabetesFlex
- Registration Number
- NCT03202732
- Lead Sponsor
- Annesofie Lunde Jensen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 344
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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DiabetesFlex 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.
- Primary Outcome Measures
Name Time Method HbA1c 15 mounth Non-inferiority with respect to HbA1c
- Secondary Outcome Measures
Name Time Method Patient Activated Measure (PAM) 15 mounth Patient Activated Measure (PAM) will be measured at baseline and after 15 months.
"Generic questions concerning patient involvement" is validate by "DEFACTUM" 15 mounth Patient involvement will be measured at baseline and after 15 months.
General health will be assessed by items from the SF-36 questionnaire 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) 15 mounth Health literacy will be measured at baseline and after 15 months.
The problem Areas In Diabetes Scale (PAID) 15 mounth PAID will be measured at baseline and after 15 months.
Number and type consultations 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
Well-being will be assessed by the WHO-5 Well-being Index 15 mounth Well-being will be measured at baseline and after 15 months.
Blood pressure 15 mounth Blood pressure will be measured at baseline and after 15 months.
Urine albumine/creatinine ratio 15 mounth urine albumine/creatinine ratio will be measured at baseline and after 15 months.
Mortality 15 mounth Mortality will be measured after 15 months.
Trial Locations
- Locations (1)
Aahurs University Hospital
🇩🇰Aarhus, Denmark