Clinical trial NCT01570140: Large Scale Demonstrator, Webportal Diabetes
Official title: Large Scale Demonstrator, Webportal Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Medical Research Foundation, The Netherlands
Sponsor class: OTHER
Collaborators: name: Isala
name: University Medical Center Groningen
First posted: 2012-04-04
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study consists of people known with type 2 diabetes mellitus who are being guided and treated in primary health care in the Drenthe region of the Netherlands.

Brief summary: Rationale: Accounting for the growth, aging and detrimental life style changes in the Dutch population, the investigators expect further growth of number of known diabetes patients. The economic burden with this increase will be enormous, the healthcare system is under increasing pressure to provide better but more time efficient service to more people with limited human resources. the investigators hypothesize that, by increasing the patients self-management by offering remote care services, this reduction of the individual caseload can be achieved.

Objective: Primary objective is to test the hypothesis that the consistent use of a web portal and its educational content and the possibility to review personal diabetes related data for type 2 diabetes patients (T2DM) in the primary care setting, will result in an improvement quality of life.

Study design and methods: In this Prospective observational cohort study the investigators examine the effect of the voluntarily use of a web portal and its educational content. The primary end point is health related quality of life. We predefined a clinically relevant difference of 0.074 in the EQ-5D index score. Secondary endpoints are diabetes-related distress and well being and a selection of clinical measurements, number of contacts with health care provider and the amount of prescribed medication. The participants are being followed for 1-year and the data will be collected at baseline, after 6 months and 12 months.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of type 2 diabetes mellitus, as registered in the primary care system under the diagnosis T90.2, and where the GP is defined as the main care giver
* Aged 18 years or older

Exclusion Criteria:

Cohort study:

* None

Intervention study:

* Mental retardation or psychiatric treatment for schizophrenia, organic mental disorder or bipolar disorder currently or in the past
* Insufficient knowledge of the Dutch language to understand the requirements of the study and/or the questions posed in the questionnaires
* Life expectancy \< 1 year due to malignancies or other terminal illnesses
* Cognitive impairment, including dementia, that interferes with trial participation
* Any condition that the Investigator and/or Coordinating Investigator feels would interfere with trial participation or evaluation of results

Primary outcomes:
measure: Health Related Quality of Life
timeFrame: 12 months
Secondary outcomes:
measure: Well-being Index: WHO-5 questionnaire
timeFrame: 12 months
measure: Diabetes-related distress
timeFrame: 12 months
measure: Assessing self-efficacy
timeFrame: 12 months
measure: Evaluation of general practice
timeFrame: 12 months
measure: Clinical parameters
timeFrame: 12 months
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Clinics
Study officials:
References:
citation: Mencke R, van der Vaart A, Pasch A, Harms G, Waanders F, Bilo HJG, van Goor H, Hillebrands JL, van Dijk PR. Serum calcification propensity is associated with HbA1c in type 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2021 Feb;9(1):e002016. doi: 10.1136/bmjdrc-2020-002016.
citation: Waanders F, Dullaart RPF, Vos MJ, Hendriks SH, van Goor H, Bilo HJG, van Dijk PR. Hypomagnesaemia and its determinants in a contemporary primary care cohort of persons with type 2 diabetes. Endocrine. 2020 Jan;67(1):80-86. doi: 10.1007/s12020-019-02116-3. Epub 2019 Oct 24.
citation: Hendriks SH, Blanker MH, Roelofsen Y, van Hateren KJJ, Groenier KH, Bilo HJG, Kleefstra N. Gender differences in the evaluation of care for patients with type 2 diabetes: a cross-sectional study (ZODIAC-52). BMC Health Serv Res. 2018 Apr 10;18(1):266. doi: 10.1186/s12913-018-3086-x.
citation: Roelofsen Y, van Vugt M, Hendriks SH, van Hateren KJ, Groenier KH, Snoek FJ, Kleefstra N, Huijsman R, Bilo HJ. Demographical, Clinical, and Psychological Characteristics of Users and Nonusers of an Online Platform for T2DM Patients (e-VitaDM-3/ZODIAC-44). J Diabetes Res. 2016;2016:6343927. doi: 10.1155/2016/6343927. Epub 2015 Nov 22.
citation: Roelofsen Y, Hendriks SH, Sieverink F, van Vugt M, van Hateren KJ, Snoek FJ, de Wit M, Gans RO, Groenier KH, van Gemert-Pijnen JE, Kleefstra N, Bilo HJ. Design of the e-Vita diabetes mellitus study: effects and use of an interactive online care platform in patients with type 2 diabetes (e-VitaDM-1/ZODIAC-40). BMC Endocr Disord. 2014 Mar 4;14:22. doi: 10.1186/1472-6823-14-22.