- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00950040
Brief Alcohol Intervention to Reduce At-Risk Drinking Among Type 2 Diabetics (SUGAR)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
At-risk drinking is common among diabetic patients and is associated with inferior diabetes treatment adherence and outcomes. While methods for reducing alcohol use in this population have been largely unexplored to date, brief interventions to reduce at-risk drinking have been well-validated in other patient populations and offer the promise to reduce at-risk drinking among diabetic patients, resulting in improved diabetes treatment adherence and outcomes.
We hypothesize that adding a brief alcohol intervention to standard diabetes treatment, relative to general health education, will reduce overall drinking volume and heavy drinking days among diabetic patients who are at-risk drinkers.
Furthermore, we expect participants who receive the brief alcohol intervention to have better diabetes treatment adherence and outcomes than the participants receiving general health education. We also expect that reduced alcohol consumption will mediate the effect of the brief alcohol intervention on diabetes treatment adherence and outcomes. In addition, we will explore potential treatment mechanisms.
The proposed study is a randomized, two-group design with repeated measures over time, comparing a brief alcohol intervention plus standard diabetes treatment to general health education. For this study, we will recruit a sample of 240 Type 2 diabetic patients from a large, urban primary care clinic. To be eligible for the study, patients must report at-risk drinking and poor diabetes treatment adherence.
This study holds the promise of establishing an efficacious intervention approach for Type 2 diabetic patients who are at-risk drinkers and are likely to maintain poor diabetes treatment adherence and outcomes in the absence of a change in their drinking behavior, resulting in increased diabetes-related morbidity and mortality. The intervention proposed in this study represents a novel approach to reducing at-risk drinking among diabetic patients that, if efficacious, can be readily integrated into the treatment of diabetes in a variety of treatment settings. In addition, this study will provide valuable information regarding the relationship between alcohol use and diabetes treatment adherence and outcomes and about the mechanisms of change in alcohol use among Type 2 diabetic patients who are at-risk drinkers.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Rhode Island
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Providence, Rhode Island, Stati Uniti, 02903
- Rhode Island Hospital
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 18 years or older,
- have Type 2 diabetes,
- report at-risk drinking in past month,
- report poor diabetes treatment adherence.
Exclusion Criteria:
- current alcohol dependence or current psychoactive substance abuse or dependence (excluding nicotine),
- currently psychotic,
- unable to provide the name and contact information for a significant other to corroborate self-report,
- unable to provide the name and contact information for two people who could serve as locators, do not have access to a telephone.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Brief alcohol intervention
Brief alcohol intervention delivered in 2 15-minute in-person sessions and 2 5-minute telephone sessions.
|
The intervention consists of educational information, aspects of motivational interviewing, feedback concerning alcohol use and measures of glycemic control, alcohol use monitoring, and formulation of a change plan.
|
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Comparatore attivo: General Health Education
General health education intervention delivered in 2 15-minute in-person sessions and 2 5-minute telephone sessions.
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The intervention will consist of information about several general health behaviors.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Number of drinks per day
Lasso di tempo: 1, 3, 6, and 12 months
|
1, 3, 6, and 12 months
|
|
Percentage heavy drinking days
Lasso di tempo: 1, 3, 6, and 12 months
|
1, 3, 6, and 12 months
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Summary of Diabetes Self-Care Activities subscale scores
Lasso di tempo: 1, 3, 6, and 12 months
|
1, 3, 6, and 12 months
|
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HbA1c levels
Lasso di tempo: 3, 6, and 12 months
|
3, 6, and 12 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Susan E Ramsey, Ph.D., Rhode Island Hospital
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 (Effettivo)
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
- AA017418
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 .