Type1 Diabetes Mellitus
Conditions
Keywords
Self-management, Patient Activeted measure, Patient-reported outcome, Type 1 diabetes Mellitus, Non-inferiority study
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.
Interventions
OTHERDiabetesFlex
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.
Sponsors
Annesofie Lunde Jensen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 15 mounth | Non-inferiority with respect to HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Patient Activated Measure (PAM) | 15 mounth | Patient Activated Measure (PAM) will be measured at baseline and after 15 months. |
| Mortality | 15 mounth | Mortality will be measured after 15 months. |
| The problem Areas In Diabetes Scale (PAID) | 15 mounth | PAID 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. |
| 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 |
| Generic questions concerning patient involvement is validate by DEFACTUM | 15 mounth | Patient involvement will be measured at baseline and after 15 months. |
Countries
Denmark
Outcome results
None listed