- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00950040
Brief Alcohol Intervention to Reduce At-Risk Drinking Among Type 2 Diabetics (SUGAR)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Rhode Island
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Providence, Rhode Island, Vereinigte Staaten, 02903
- Rhode Island Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Aktiver Komparator: General Health Education
General health education intervention delivered in 2 15-minute in-person sessions and 2 5-minute telephone sessions.
|
The intervention will consist of information about several general health behaviors.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Number of drinks per day
Zeitfenster: 1, 3, 6, and 12 months
|
1, 3, 6, and 12 months
|
|
Percentage heavy drinking days
Zeitfenster: 1, 3, 6, and 12 months
|
1, 3, 6, and 12 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Summary of Diabetes Self-Care Activities subscale scores
Zeitfenster: 1, 3, 6, and 12 months
|
1, 3, 6, and 12 months
|
|
HbA1c levels
Zeitfenster: 3, 6, and 12 months
|
3, 6, and 12 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Susan E Ramsey, Ph.D., Rhode Island Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- AA017418
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