Large Scale Demonstrator, Webportal Diabetes

Diabetes Mellitus Type 2 Clinical Trial

— LSD  

Official title:

Large Scale Demonstrator, Webportal Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570140
• Other study ID #: LSD
• Status: Completed
• First received: March 29, 2012
• Last updated: March 20, 2018
• Start date: May 2012
• Est. completion date: October 2015

Study information

• Verified date: March 2018
• Source: Medical Research Foundation, The Netherlands
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: October 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Web portal
This study investigates the effects of the voluntarily use of a webportal and its educational content.

Locations

Country	Name	City	State
Netherlands	Isala Clinics	Zwolle

Sponsors (3)

Lead Sponsor	Collaborator
Henk Bilo, MD	Isala, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Related Quality of Life	EQ-5D questionnaire, representing Health Related Quality of Life dimension	12 months
Secondary	Well-being Index: WHO-5 questionnaire	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	12 months
Secondary	Diabetes-related distress	PAID-5, questionnaire for diabetes-related distress	12 months
Secondary	Assessing self-efficacy	SDSCA, assessing self-efficacy	12 months
Secondary	Evaluation of general practice	Europep questionnaire, evaluation of general practice	12 months
Secondary	Clinical parameters	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	12 months