Clinical trial NCT03083899: The Diabetes Patient Takes Responsibility
Official title: DiaTast - Patient Reported Experience in a New Out-patient Structure With Patient-initiated Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Patient Reported Outcome
Health Care Economics and Organizations
Keywords: Diabetes
Organization
Out-patient control
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient reported outcome
timeFrame: 24 month
Secondary outcomes:
measure: Clinical diabetes variables 1
timeFrame: 24 month
measure: Health Care Economy
timeFrame: 24 month
measure: Clinical diabetes variables 2
timeFrame: 24 month
measure: Clinical diabetes variables 3
timeFrame: 24 month
measure: Diabetes Dependent quality of Life
timeFrame: 24 month
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Hospital of South West Jutland, University hospital of Southern Denmark
Study officials:
affiliation: Esbjerg Hospital - University Hospital of Southern Denmark
name: Claus B Juhl, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: