Alcohol AbuseNCT01830114
A Web App for Patients With Alcohol and Drug Use Problems in Primary Care
A study testing Web app in people with Alcohol Abuse and Drug Abuse, run by Behavior Therapy Associates, LLP at 1 site in United States.
Trial summary
The objective of this pilot study is to evaluate the feasibility and technical merit of a web application for patients in primary care called Check-up and Choices (CC). Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse, Drug Abuse
- What is being tested?
- Web app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- physicians,
- nurses,
- nurse practitioners,
- physician's assistants,
- psychologists embedded in primary care settings, and
- other mental health counselors embedded in primary care settings.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavior Therapy Associates, LLC
Albuquerque, New Mexico, 87112
About this study
The objective of this pilot study is to evaluate the feasibility and technical merit of a web application for patients in primary care called Check-up and Choices (CC).
Read the detailed description
The overall objective of this project is to develop, evaluate, and disseminate a web application called Check-up and Choices (CC). CC will be developed for use in primary care. It would tightly integrate screening for heavy drinking and drug use, a brief motivational intervention for hazardous or heavy drinkers, a moderation training protocol for less dependent problem drinkers, and an abstinence-oriented protocol for more dependent drinkers and drug abusers. The brief motivational intervention will be tailored to the patient's age. Its purpose will be to motivate problem drinkers to change their drinking. The action-oriented moderation and abstinence protocols are cognitive-behavioral interventions (CBIs) that provide patients with the skills to maximize their chances of success with changing their drinking and/or drug use.
The investigators have already developed these elements but they are not integrated into a single program with appropriate branching between them. Nor has the content been tailored for use in primary care.
- Conditions
- Alcohol Abuse, Drug Abuse
- Being tested
- Web app
- Keywords
- alcohol abuse, drug abuse, hazardous alcohol use, hazardous drug use
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web appBehavioural
The Checkup and Choices web application
| Study group | Role | What they receive |
|---|---|---|
| Web app evaluation group | Experimental | Not described Receives: Behavioral: Web app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Questionnaire
A 17 item questionnaire that asks about the feasibility of using the web app with patients in primary care and the app's technical merit.
Measured: Within 1 month of enrollment with an expected average of 1 week..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Behavior Therapy Associates, LLP
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830114
- Sponsor's protocol ID
- CheckupAndChoicesPilot
- Other IDs
- 1R43AA022024-01
- Status last verified
- Jun 2013
- First submitted
- 8 Apr 2013
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Web App for Patients With Alcohol and Drug Use Problems in Primary Care
- ClinicalTrials.gov ID
- NCT01830114
- Acronym / sponsor ID
- CheckupAndChoicesPilot
- Conditions
- Alcohol Abuse, Drug Abuse
- Keywords
- alcohol abuse, drug abuse, hazardous alcohol use, hazardous drug use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Behavior Therapy Associates, LLPIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this pilot study is to evaluate the feasibility and technical merit of a web application for patients in primary care called Check-up and Choices (CC).
Detailed description
The overall objective of this project is to develop, evaluate, and disseminate a web application called Check-up and Choices (CC). CC will be developed for use in primary care. It would tightly integrate screening for heavy drinking and drug use, a brief motivational intervention for hazardous or heavy drinkers, a moderation training protocol for less dependent problem drinkers, and an abstinence-oriented protocol for more dependent drinkers and drug abusers. The brief motivational intervention will be tailored to the patient's age. Its purpose will be to motivate problem drinkers to change their drinking. The action-oriented moderation and abstinence protocols are cognitive-behavioral interventions (CBIs) that provide patients with the skills to maximize their chances of success with changing their drinking and/or drug use.
The investigators have already developed these elements but they are not integrated into a single program with appropriate branching between them. Nor has the content been tailored for use in primary care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Web app evaluation group | Experimental | Behavioral: Web app |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- physicians,
- nurses,
- nurse practitioners,
- physician's assistants,
- psychologists embedded in primary care settings, and
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web appThe Checkup and Choices web application | Behavioural | Web app evaluation group |
Primary outcome
Feasibility Questionnaire
Time frame: Within 1 month of enrollment with an expected average of 1 week..
A 17 item questionnaire that asks about the feasibility of using the web app with patients in primary care and the app's technical merit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web app in people with Alcohol Abuse and Drug Abuse, run by Behavior Therapy Associates, LLP at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Questionnaire (time frame: Within 1 month of enrollment with an expected average of 1 week..). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2013.