NCT03083899

The Diabetes Patient Takes Responsibility

DiaTast - Patient Reported Experience in a New Out-patient Structure With Patient-initiated Visits

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1
• Patient Reported Outcome
• Health Care Economics and Organizations

Interventions

Type	Name	Description
OTHER	Out-patient clinic on demand (patient-initiated)	Free use of any resources in the out-patient clinic
OTHER	Scheduled out-patient clinic	Scheduled use of the out-patient clinic

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-12-22
• Completion: 2019-12-22
• First posted: 2017-03-20
• Last updated: 2020-12-14

Locations

1 site across 1 country: Denmark