Diabetes Mellitus, Type 1, Health Care Economics and Organizations, Patient Reported Outcome
Conditions
Keywords
Diabetes, Organization, Out-patient control
Brief summary
People with Type 1 diabetes (T1D) are randomized to follow the normal scheduled visit procedure in the outpatient clinic OR to have open access to the clinic, i.e. they can get an appointment with a nurse or doctor within defined time intervals via telephone, e-mail or apps. Patient-reported outcomes (patient satisfaction and experience, QoL) clinical variables (HbA1c, blood pressure etc.) and use of human resources (doctors, diabetes-nurses and diet physicians) are monitored.
Detailed description
This is a 24 month prospective randomized controlled trial. People with Type 1 diabetes (T1D) are randomized to two groups: (i) Patients randomized to the control group receive their standard diabetes care and are seen in the out-patient clinic with regular intervals (typically a diabetes nurse every 3-4 month and a diabetes doctor once a year. (ii) Patients randomized to the intervention group are not called for at fixed time points. They can arrange visits in the diabetes clinic whenever they feel the need to do so. The have a guarantee for a consultation with a diabetes nurse within one week and with a diabetes doctor or diet physician within two weeks. Questionnaires (a specific questionnaire focused on patient satisfaction developed for the study and AddQoL) are filled in at time 0 and 24 month. Blood samples for diabetes-related variables (HbA1c, lipid status), blood pressure, body weight etc. are likewise recorded at time 0 and 24 month. Economic and time requirements are evaluated at 24 month.
Interventions
OTHEROut-patient clinic on demand (patient-initiated)
Free use of any resources in the out-patient clinic
OTHERScheduled out-patient clinic
Scheduled use of the out-patient clinic
Sponsors
Esbjerg Hospital - University Hospital of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Type 1 diabetes 18 - 80 years Multiple injections or Insulin pump therapy
Exclusion criteria
Newly diagnosed T1D Psychiatric illness Need for translation Unstable conditions such as progressive retinopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported outcome | 24 month | Questionnaire regarding satisfaction of the out-patient clinic |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical diabetes variables 1 | 24 month | HbA1c |
| Health Care Economy | 24 month | Use of resources in the out-patient clinic |
| Clinical diabetes variables 2 | 24 month | Blood pressure |
| Clinical diabetes variables 3 | 24 month | Lipids |
| Diabetes Dependent quality of Life | 24 month | Questionnaire |
Countries
Denmark
Outcome results
None listed