Large Scale Demonstrator, Webportal Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Digital, Blended Lifestyle Intervention for Type 2 Diabetes Remission

NCT05346614

Diabetes Mellitus, Type 2

UNKNOWN NA

"POWER2DM Evaluation Campaign"

NCT03588104

Type1 Diabetes Mellitus Type2 Diabetes Mellitus Diabetes Mellitus +2 more

COMPLETED NA

A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community

NCT02114814

Diabetes Mellitus, Type 2

COMPLETED NA

Economic Evaluation of a Multistage Shared Decision-making Program for Type 2 Diabetes: a Pilot Study

NCT06410768

Diabetes Mellitus, Type 2

ENROLLING_BY_INVITATION NA

Use of Midlevel Providers in Diabetes Management

NCT00237094

Diabetes Mellitus

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Web portal users

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

Web portal

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Web portal

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No