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Alcohol AbuseNCT02681406

Smartphone Based Continuing Care for Alcohol

A study testing ACHESS and TMC in people with Alcohol Abuse, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Investigators will recruit 280 alcohol dependent patients in treatment programs in the Philadelphia area to test the efficacy and cost efficiency of a smartphone based application for treating alcohol addiction (ACHESS) with telephone monitoring and counseling (TMAC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Alcohol Abuse
What is being tested?
ACHESS and TMC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
262 participants
Where
1 siteUnited States
Study dates
Sep 2014to 15 Mar 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • have a DSM-V diagnosis of current, moderate to severe alcohol use disorder
  • have completed 3 weeks of IOP
  • be 18-75 years of age
  • be able to provide the name and verified telephone number of at least two contacts to help reach participants for follow up appointments
  • functionally literate and have sufficient ability to read a smart phone
  • be willing to be randomized as part of the clinical trial

Who cannot join

  • have a current psychotic disorder or dementia severe enough to prevent participation in treatment
  • have an acute medical problem requiring immediate inpatient treatment
  • are participating in other forms of treatment for substance abuse, besides IOP
  • are unable to read/comprehend for informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Impact of Enhancements to Smartphone Based Continuing Care for Alcohol Dependence

Investigators will recruit 280 alcohol dependent patients in treatment programs in the Philadelphia area to test the efficacy and cost efficiency of a smartphone based application for treating alcohol addiction (ACHESS) with telephone monitoring and counseling (TMAC). Participation in the study lasts for 18 months with research visits at baseline, 3 months, 6 months, 9 months, 12 months, and 18 months. The intervention lasts 12 months.

Read the detailed description

Continuing care is believed to be important in the effective management of patients with alcohol use disorders. New smartphone technology provides a novel way to provide personalized continuing care support. Dr. Gustafson and colleagues at the University of Wisconsin have developed an addiction version of CHESS (ACHESS), an automated smart phone system that provides a range of functions designed to directly support patients. In a recently completed NIAAA-funded continuing care study, ACHESS produced better drinking outcomes with alcoholics than treatment as usual.

The Principal Investigator of the current study, Dr. Jim McKay, and his colleagues at the Center of Continuum of Care in the Addictions have also developed a telephone-based approach to continuing care, Telephone Monitoring and Counseling (TMC), which has demonstrated efficacy in two randomized trials with alcohol-dependent patients. The TMC intervention is delivered through telephone contacts between patients and counselors, and makes use of information obtained in a brief assessment at the beginning of each call to determine the content of the session and to trigger adaptive changes in level of care over time.

Although both ACHESS and TMC use telephone technology, they have complementary strengths. ACHESS provides a range of automated 24/7 recovery support services, but does not include contact with a counselor. TMC, on the other hand, provides regular and sustained contact with the same counselor, but does not provide support between calls. The future of continuing care for alcohol use disorders is likely to involve both automated mobile technology and counselor contact, but little is known about how best to integrate these services.

To address this question, the study will feature a 2 x 2 design [ACHESS for 12 months (yes/no) x TMC for 12 months (yes/no)]. With this design, we will determine whether adding TMC to ACHESS produces superior outcomes to those obtained with TMC or ACHESS alone. This design will also enable replication of prior findings, and will provide the first direct comparison of TMC only vs. ACHESS only. In addition, economic analyses will be completed to determine the cost and cost-effectiveness of each intervention and their combination. The participants will be randomly assigned into one of the four conditions and followed for 18 months. The follow-ups will be at 3, 6, 9, 12, and 18 months post-baseline.

The subjects will be 280 patients diagnosed with alcohol abuse who are in a substance abuse treatment center in the Philadelphia area.

The risks of the research are conceived to be minimal (e.g., possible embarrassment) and consist of those incurred in providing self-report data on alcohol and drug-related history and social and psychiatric problems. There are minimal medical risks associated with research participation. There will be some risk of loss of confidentiality since the name, addresses and phone numbers of three contact people will be recorded by the staff for subject tracking purposes. However, all identifiable information will remain in a locked filling cabinet only accessible by the principle investigator and study staff. No identifying information will be programmed into the phone by the counselor. Although the participant is able to program numbers into the smartphone once they receive one, the counselor will review several measures for protecting the subjects' privacy, including password and pattern locks. All subjects will receive at a minimum treatment as usual in the programs from which they will be recruited.

Conditions
Alcohol Abuse
Being tested
ACHESS, TMC
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACHESSBehavioural

    Smartphone based additions focused application, encouraging social support

  • TMCBehavioural

    Brief telephone monitoring and counseling

Study groups in NCT02681406
Study groupRoleWhat they receive
Treatment as UsualNo interventionParticipants randomized to this condition will continue their schedules and treatments as they had been and just come in to see research staff for research visits.
Telephone Monitoring and CounselingExperimentalTMC - participants receive brief (20 minute) telephone counseling once weekly, then biweekly, etc for 12 months.
Receives: Behavioral: TMC
ACHESSExperimentalParticipants are signed up for an addiction based smart phone application that connects them in an anonymous fashion to a social network of other people in the study who are also struggling with alcohol addiction and sober living.
Receives: Behavioral: ACHESS
TMC + ACHESSExperimentalParticipants in this arm receive both interventions - the telephone counseling plus the ACHESS phone application.
Receives: Behavioral: ACHESS; Behavioral: TMC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time Line Follow Back, Percent Heavy Alcohol Use

    The primary outcome measure will be percent days of heavy alcohol use (i.e., > 5 drinks/day for men, > 4 drinks/day for women) within each follow-up period. Studies have consistently supported the reliability and validity of the TLFB with alcohol dependent individuals. Frequency of heavy alcohol use was selected because alcohol-related problems are correlated with the frequency of heavy drinking days. This outcome is also sensitive to reductions in problematic or high risk use, which are particularly important in a disease management model.

    Measured: 18 month: months 13 - 18 post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2016 (estimated)
  2. Study startSep 2014
  3. Primary completion15 Mar 2020
  4. Study completion15 Mar 2020

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
262 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02681406
Sponsor's protocol ID
819881
Status last verified
Mar 2022
First submitted
9 Feb 2016
Last updated
9 Mar 2022
Data monitoring committee
No
Individual data sharing
No

Publications

  • McKay JR, Gustafson DH, Ivey M, Pe-Romashko K, Curtis B, Thomas T, Oslin DW, Polsky D, Quanbeck A, Lynch KG. Efficacy and comparative effectiveness of telephone and smartphone remote continuing care interventions for alcohol use disorder: a randomized controlled trial. Addiction. 2022 May;117(5):1326-1337. doi: 10.1111/add.15771. Epub 2021 Dec 23.

    PubMed 34859519
  • McKay JR, Gustafson DH, Ivey M, McTavish F, Pe-Romashko K, Curtis B, Oslin DA, Polsky D, Quanbeck A, Lynch KG. Effects of automated smartphone mobile recovery support and telephone continuing care in the treatment of alcohol use disorder: study protocol for a randomized controlled trial. Trials. 2018 Jan 30;19(1):82. doi: 10.1186/s13063-018-2466-1.

    PubMed 29382367

Questions about this trial

What is this clinical trial studying?

A study testing ACHESS and TMC in people with Alcohol Abuse, run by University of Pennsylvania 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 4 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 9 Mar 2022. 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?

Yes. Results are posted in the registry (first posted 9 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time Line Follow Back, Percent Heavy Alcohol Use (time frame: 18 month: months 13 - 18 post baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02681406, which also lists 2 linked publications.

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 9 Mar 2022.

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