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The Clinical and Economic Impacts of e-Heath on Diabetes (eHealthDM)

8 maggio 2012 aggiornato da: Dr. Danièle Pacaud

This project addresses the following Null Hypotheses:

  1. There will be no difference will be found in the use of the search engine and the information accessed among the three education modes.
  2. There will be no difference in education mode's effect on metabolic control, self-care management practices, and medical resource utilization.
  3. There will be no difference in the economic impact on the health care system based on differing education modes.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

In addition to the face-to-face education process currently used at the CHR, this project will develop two modes of eHealth education. Education mode 1 (control) is comprised of participants educated using CHR's current traditional face-to-face delivery method, with printed materials and written log journals. These participants will be trained to use the University's web portal if they elect to access internet-based diabetes information. This allows for the tracking of the type and amounts of diabetes information accessed by participants. Education mode 2 (static interface) participants will be educated using digitized forms of the traditional materials provided by CHR as well as an electronic log journal (e-journal) where participants will record their diabetes-related outcomes and behavioural information. Education mode 2 will be assessed and approved by CHR. Education mode 3 (dynamic interface) participants will be educated using the digitized traditional materials from education mode 2 as well as an enhanced dynamic e-journal (visualization of blood glucose and alerts). In addition, this mode will provide informative disease-related internet sites and diabetes news and articles vetted by the medical team. Participants and health professionals will then be able to electronically discuss the content and quality of this information (discussion board). New sites and articles will be added on an ongoing basis. Participants will also have access to a chat room that will encourage information sharing with other education mode 3 participants and health professionals at CHR. Education mode 3 will be assessed and approved by CHR.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

79

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • Alberta
      • Lethbridge, Alberta, Canada
        • Calgary Health Region's offices across southwestern Alberta

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Aged 18 or older
  • Literate
  • Not participating in other clinical trials
  • Diabetes diagnosed within the last three months
  • Type 2 diabetes
  • No medical conditions that could compromise metabolic control
  • No linguistic, cognitive or psychosocial barriers that would hinder study completion
  • Computer and internet literate
  • Access to high-speed internet

Exclusion Criteria:

  • Under the age of 18
  • Not literate
  • Participating in other clinical trials
  • Diabetes diagnosed greater than three months ago
  • Type 1 diabetes
  • Gestational diabetes
  • Additional medical conditions that could compromise metabolic control
  • Linguistic, cognitive or psychosocial barriers that would hinder study completion
  • Not computer and internet literate
  • No access to high-speed internet

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Education mode 1 (control)
Education mode 1 (control) is comprised of participants educated using CHR's current traditional face-to-face delivery method, with printed materials and written log journals. These participants will be trained to use the University's web portal if they elect to access internet-based diabetes information. This allows for the tracking of the type and amounts of diabetes information accessed by participants.
Altro: eHealth education
In addition to the face-to-face education process currently used at the CHR, Education mode 1 (control), Education mode 2 (static interface) and Education mode 3 (dynamic interface) will be used.
Comparatore attivo: Education mode 2 (static interface)
Education mode 2 (static interface) participants will be educated using digitized forms of the traditional materials provided by CHR as well as an electronic log journal (e-journal) where participants will record their diabetes-related outcomes and behavioural information. Education mode 2 will be assessed and approved by CHR.
Altro: eHealth education
In addition to the face-to-face education process currently used at the CHR, Education mode 1 (control), Education mode 2 (static interface) and Education mode 3 (dynamic interface) will be used.
Comparatore attivo: Education mode 3 (dynamic interface)
Education mode 3 (dynamic interface) participants will be educated using the digitized traditional materials from education mode 2 as well as an enhanced dynamic e-journal (visualization of blood glucose and alerts). In addition, this mode will provide informative disease-related internet sites and diabetes news and articles vetted by the medical team. Participants and health professionals will then be able to electronically discuss the content and quality of this information (discussion board). New sites and articles will be added on an ongoing basis. Participants will also have access to a chat room that will encourage information sharing with other education mode 3 participants and health professionals at CHR. Education mode 3 will be assessed and approved by CHR.
Altro: eHealth education
In addition to the face-to-face education process currently used at the CHR, Education mode 1 (control), Education mode 2 (static interface) and Education mode 3 (dynamic interface) will be used.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in A1C
Lasso di tempo: baseline, 3, 6, 9, 12 months
A1C is a measure of metabolic control in diabetes. For this study changes in A1C from baseline to 3, 6, 9 and 12 months were measured. All A1C were measured in provincial laboratories using 6.1% as the upper limit of normal for individuals without diabetes.
baseline, 3, 6, 9, 12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
a reduction in the cost of delivering health information and education processes
Lasso di tempo: baseline and 12 months
Secondary effects could include a change in the cost of delivering health information and education processes. Potential changes to self-care management practices of people with type II diabetes could lead to a reduced utilization of the heath care system resulting in a positive economic impact.
baseline and 12 months
Changes in Diabetes Knowledge
Lasso di tempo: baseline, 3, 6, 9, 12 months
Changes in diabetes knowledge from baseline to 3, 6, 9, and 12 months will be measured using a 23 item multiple choice questionnaire devolopped by Fitzgerald et al 1998.
baseline, 3, 6, 9, 12 months
Changes in Diabetes self-care activities
Lasso di tempo: Baseline, 3, 6, 9 and 12 months
Changes in diabetes self-care activities from base line to 3, 6, 9, and 12 months will be measured the diabetes self-care activities tool evaluated by Toobert at al (2000).
Baseline, 3, 6, 9 and 12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Dr. Danièle Pacaud

Collaboratori

The Lawson Foundation

Investigatori

  • Investigatore principale: Angela M Downey, PhD, CMA, FCMA, University of Lethbridge
  • Investigatore principale: Helen Kelley, PhD, University of Lethbridge

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2007

Completamento primario (Effettivo)

1 dicembre 2008

Completamento dello studio (Effettivo)

1 dicembre 2009

Date di iscrizione allo studio

Primo inviato

3 marzo 2011

Primo inviato che soddisfa i criteri di controllo qualità

8 maggio 2012

Primo Inserito (Stima)

10 maggio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

10 maggio 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 maggio 2012

Ultimo verificato

1 maggio 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • LAWSON-686

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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