- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02122250
Web-based Support for People With Type 2 Diabetes
Developing and Testing Accessible Web-based Support for Patient Self-management of Diabetes
This project will address vital questions regarding how best to design web-based materials for the growing population of patients with basic literacy and computer skills but lower levels of health literacy, building on our previous experience of developing web-based materials for people with lower levels of literacy and health literacy.
This study will be carried out two phases. Phase 1 will use qualitative methods to understand user experiences of the web-based materials through observational 'think-aloud' interviews with users. Phase 2 will test the newly developed web-based materials to a static (non-interactive) version of the materials online.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Potential participants are patients with Type 2 diabetes aged 18 years or more, who are able to consent.
Exclusion Criteria:
- Severe mental health problems, palliative care, recent bereavement, known opposition to involvement in research or inability to complete research measures, e.g. learning disability, inability to read / speak English.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Interactive web-based materials
Interactive web-based materials for self-management of diabetes
|
Interactive web-based materials for self-management of diabetes
|
|
Comparatore attivo: Static web-based materials
Static version of the interactive web-based materials
|
Static web-based materials
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
user engagement
Lasso di tempo: This will be measured by intervention completion rates
|
This will be measured by intervention completion rates
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Patient enablement
Lasso di tempo: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
|
Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
|
|
Website satisfaction
Lasso di tempo: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
|
Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
|
|
Physical activity attitudes and intentions
Lasso di tempo: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
|
Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
|
|
Diabetes and Physical activity knowledge
Lasso di tempo: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
|
Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
|
Altre misure di risultato
Misura del risultato |
Lasso di tempo |
|---|---|
|
Single item: whether you would recommend the website to others
Lasso di tempo: Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
|
Participants will be followed up as soon as they finished looking at the website, which is expected to be 20-40 minutes after they start the study.
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Lucy Yardley, University of Southampton
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 4746
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 .