DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes

Type1 Diabetes Mellitus Clinical Trial

Official title:

DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes: A Randomised Controlled Trial and Interview Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202732
• Other study ID #: DiabetesFlex2017
• Status: Completed
• Phase: N/A
• Start date: October 9, 2017
• Est. completion date: August 25, 2020

Study information

• Verified date: November 2020
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: August 25, 2020
• Est. primary completion date: August 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus

Intervention

Other:
• DiabetesFlex
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.

Locations

Country	Name	City	State
Denmark	Aahurs University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Annesofie Lunde Jensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Non-inferiority with respect to HbA1c	15 mounth
Secondary	General health will be assessed by items from the SF-36 questionnaire	General health will be measured at baseline and after 15 mounth	15 mounth
Secondary	Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 6 and 9)	Health literacy will be measured at baseline and after 15 months.	15 mounth
Secondary	Well-being will be assessed by the WHO-5 Well-being Index	Well-being will be measured at baseline and after 15 months.	15 mounth
Secondary	Patient Activated Measure (PAM)	Patient Activated Measure (PAM) will be measured at baseline and after 15 months.	15 mounth
Secondary	"Generic questions concerning patient involvement" is validate by "DEFACTUM"	Patient involvement will be measured at baseline and after 15 months.	15 mounth
Secondary	The problem Areas In Diabetes Scale (PAID)	PAID will be measured at baseline and after 15 months.	15 mounth
Secondary	Blood pressure	Blood pressure will be measured at baseline and after 15 months.	15 mounth
Secondary	Urine albumine/creatinine ratio	urine albumine/creatinine ratio will be measured at baseline and after 15 months.	15 mounth
Secondary	Number and type consultations	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	15 mounth
Secondary	Mortality	Mortality will be measured after 15 months.	15 mounth

External Links

•   Homepage which descrip the intervention DiabetesFlex