NCT01570140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
27 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

2.8 years

First QC Date

March 29, 2012

Last Update Submit

March 20, 2018

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • Health Related Quality of Life

    EQ-5D questionnaire, representing Health Related Quality of Life dimension

    12 months

Secondary Outcomes (5)

  • Well-being Index: WHO-5 questionnaire

    12 months

  • Diabetes-related distress

    12 months

  • Assessing self-efficacy

    12 months

  • Evaluation of general practice

    12 months

  • Clinical parameters

    12 months

Study Arms (1)

Web portal users

T2DM patients in the primary care setting, using the web portal.

Behavioral: Web portal

Interventions

Web portalBEHAVIORAL

This study investigates the effects of the voluntarily use of a webportal and its educational content.

Web portal users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isala Clinics

Zwolle, Netherlands

Location

Related Publications (5)

  • 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.

    PMID: 33627317DERIVED

  • 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.

    PMID: 31650393DERIVED

  • 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.

    PMID: 29636042DERIVED

  • 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.

    PMID: 26682232DERIVED

  • 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.

    PMID: 24593656DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Patient Portals

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Health Records, PersonalMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 29, 2012

First Posted

April 4, 2012

Study Start

May 1, 2012

Primary Completion

February 1, 2015

Study Completion

October 1, 2015

Last Updated

March 21, 2018

Record last verified: 2018-03

Locations

NL(1)