- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00950040
Brief Alcohol Intervention to Reduce At-Risk Drinking Among Type 2 Diabetics (SUGAR)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Aktiv 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of drinks per day
Tidsramme: 1, 3, 6, and 12 months
|
1, 3, 6, and 12 months
|
|
Percentage heavy drinking days
Tidsramme: 1, 3, 6, and 12 months
|
1, 3, 6, and 12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Summary of Diabetes Self-Care Activities subscale scores
Tidsramme: 1, 3, 6, and 12 months
|
1, 3, 6, and 12 months
|
|
HbA1c levels
Tidsramme: 3, 6, and 12 months
|
3, 6, and 12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Susan E Ramsey, Ph.D., Rhode Island Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AA017418
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .