Large Scale Demonstrator, Webportal Diabetes

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Behavioral: Web portal

• Registration Number: NCT01570140
• Lead Sponsor: Henk Bilo, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-04-01
• Study First Posted: 2012-04-04
• Study Start: 2012-05
• Primary Completion: 2015-02
• Study Completion: 2015-10
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Web portal users	Web portal	T2DM patients in the primary care setting, using the web portal.

Primary Outcome Measures

Name	Time	Method
Health Related Quality of Life	12 months	EQ-5D questionnaire, representing Health Related Quality of Life dimension

Secondary Outcome Measures

Name	Time	Method
Evaluation of general practice	12 months	Europep questionnaire, evaluation of general practice
Diabetes-related distress	12 months	PAID-5, questionnaire for diabetes-related distress
Assessing self-efficacy	12 months	SDSCA, assessing self-efficacy
Well-being Index: WHO-5 questionnaire	12 months	This five items questionnaire covers positive mood, vitality and general interests. The WHO-5 measures not only the absence of symptoms but gives a reliable indication of mental well-being.This includes the following dimensions: * Good spirits; * Relaxation; * Being Active; * Waking up fresh and rested; * Being interested in things
Clinical parameters	12 months	* Quetelet index (BMI); * Systolic/diastolic blood pressure; * Creatinine; * Lipid profile fasting; * Albumin/Creatinine ratio; * MDRD; * monofilament test feet; * SIMMS classification; * Fundus photo assessment; * Smoking; * Use of alcohol; * FiveShot questionnaire; * Diabetes medicine; * Antihypertensiva; * Antilipaemica; * Additional medication; * Cardiovascular complications

Trial Locations

Locations (1)

Isala Clinics; 🇳🇱 Zwolle, Netherlands