Skip to main content
OpenTrials
Completed

NCT Number: NCT03202732

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aahurs University Hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DiabetesFlex

Other

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.

Primary outcomes

  1. HbA1c

    Time frame: 15 mounth

    Non-inferiority with respect to HbA1c

Secondary outcomes

  1. General health will be assessed by items from the SF-36 questionnaire

    Time frame: 15 mounth

    General health will be measured at baseline and after 15 mounth

  2. Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 6 and 9)

    Time frame: 15 mounth

    Health literacy will be measured at baseline and after 15 months.

  3. Well-being will be assessed by the WHO-5 Well-being Index

    Time frame: 15 mounth

    Well-being will be measured at baseline and after 15 months.

  4. Patient Activated Measure (PAM)

    Time frame: 15 mounth

    Patient Activated Measure (PAM) will be measured at baseline and after 15 months.

  5. "Generic questions concerning patient involvement" is validate by "DEFACTUM"

    Time frame: 15 mounth

    Patient involvement will be measured at baseline and after 15 months.

  6. The problem Areas In Diabetes Scale (PAID)

    Time frame: 15 mounth

    PAID will be measured at baseline and after 15 months.

  7. Blood pressure

    Time frame: 15 mounth

    Blood pressure will be measured at baseline and after 15 months.

  8. Urine albumine/creatinine ratio

    Time frame: 15 mounth

    urine albumine/creatinine ratio will be measured at baseline and after 15 months.

  9. Number and type consultations

    Time frame: 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

  10. Mortality

    Time frame: 15 mounth

    Mortality will be measured after 15 months.

Sponsors and collaborators

Lead sponsor

Annesofie Lunde Jensen

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 29, 2017
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.