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Virtual Health Coaching for Reducing Alcohol Use Around Surgery (ASPIRE-2 Trial)

N/A
Recruiting
Led By Anne Fernandez
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 months after surgical discharge
Awards & highlights

ASPIRE-2 Trial Summary

This trial tests treatments to reduce alcohol use before and after surgery to keep people healthier and well long-term.

Who is the study for?
This trial is for adults scheduled for major elective surgery (non-cancer) in the next 5-12 weeks, who drink alcohol at levels that may increase surgical risks (score ≥ 5 on AUDIT-C). They must be willing to follow study rules and have internet access. People already in another alcohol study or with severe alcohol withdrawal history can't join.Check my eligibility
What is being tested?
The study tests if treatments reducing alcohol use before and after surgery can improve recovery and long-term health. Participants receive either usual care or additional virtual coaching pre- and post-surgery, with assignments changing based on their progress.See study design
What are the potential side effects?
Since this trial involves behavioral interventions like health coaching rather than medication, typical medical side effects are not expected. However, participants might experience stress or discomfort discussing personal habits.

ASPIRE-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 months after surgical discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 months after surgical discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alcohol consumption as measured by the timeline follow-back
Secondary outcome measures
Alcohol Use Disorder Identification test (AUDIT)
World Health Organization Drinking (WHO) Risk Level

ASPIRE-2 Trial Design

10Treatment groups
Experimental Treatment
Group I: Preoperative Virtual Health Coaching then Usual Surgical CareExperimental Treatment2 Interventions
Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching
Group II: Preoperative Virtual Health Coaching then Postoperative Virtual Health CoachingExperimental Treatment2 Interventions
Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching
Group III: Preoperative Virtual Health Coaching then On-TrackExperimental Treatment2 Interventions
Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching
Group IV: Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track)Experimental Treatment3 Interventions
Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching
Group V: Preoperative Virtual Health Coaching onlyExperimental Treatment1 Intervention
Only completed first randomization. Study withdrawal prior to re-randomization.
Group VI: Enhanced Usual Care then Usual Surgical CareExperimental Treatment2 Interventions
Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care
Group VII: Enhanced Usual Care then Post-operative Health CoachingExperimental Treatment2 Interventions
Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care
Group VIII: Enhanced Usual Care then On-TrackExperimental Treatment2 Interventions
Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care
Group IX: Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track)Experimental Treatment3 Interventions
Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care
Group X: Enhanced Usual Care aloneExperimental Treatment1 Intervention
Only completed first randomization. Study withdrawal prior to re-randomization

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,377,698 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
803 Previous Clinical Trials
1,365,067 Total Patients Enrolled
Anne FernandezPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
65 Total Patients Enrolled

Media Library

Enhanced Usual Care (pre-operative) Clinical Trial Eligibility Overview. Trial Name: NCT05783635 — N/A
Alcohol Consumption Research Study Groups: Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track), Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching, Preoperative Virtual Health Coaching then Usual Surgical Care, Enhanced Usual Care alone, Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track), Enhanced Usual Care then Usual Surgical Care, Enhanced Usual Care then Post-operative Health Coaching, Enhanced Usual Care then On-Track, Preoperative Virtual Health Coaching only, Preoperative Virtual Health Coaching then On-Track
Alcohol Consumption Clinical Trial 2023: Enhanced Usual Care (pre-operative) Highlights & Side Effects. Trial Name: NCT05783635 — N/A
Enhanced Usual Care (pre-operative) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05783635 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age requirement to partake in this investigation eighteen or older?

"This medical research is seeking participants who are within the age limits of 21 to 75 years."

Answered by AI

Which patient demographics are eligible for this trial?

"Prospective enrollees must have a history of alcohol consumption and be aged between 21 to 75. This trial is looking for 440 participants in total."

Answered by AI

Is this research initiative currently recruiting new participants?

"According to clinicaltrials.gov, the recruitment of participants for this trial has been temporarily suspended as it was last updated on March 13th 2023. Nevertheless, there are 257 other trials that are currently open and actively searching for patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Alcohol Screening and Preoperative Intervention Research Study - 2
Anne Fernandez 2023. "Alcohol Screening and Preoperative Intervention Research Study - 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05783635.
~293 spots leftby Sep 2026
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