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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | Participants 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 Counseling | Experimental | TMC - participants receive brief (20 minute) telephone counseling once weekly, then biweekly, etc for 12 months. Receives: Behavioral: TMC |
| ACHESS | Experimental | Participants 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 + ACHESS | Experimental | Participants 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.
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.
- First posted12 Feb 2016 (estimated)
- Study startSep 2014
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James R. McKay, PhD, Principal investigator, University of Pennsylvania
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 34859519McKay 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Enhancements to Smartphone Based Continuing Care for Alcohol Dependence
- ClinicalTrials.gov ID
- NCT02681406
- Acronym / sponsor ID
- 819881
- Conditions
- Alcohol Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Posted 9 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | –Participants 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 Counseling | Experimental | Behavioral: TMCTMC - participants receive brief (20 minute) telephone counseling once weekly, then biweekly, etc for 12 months. |
| ACHESS | Experimental | Behavioral: ACHESSParticipants 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. |
| TMC + ACHESS | Experimental | Behavioral: ACHESS, Behavioral: TMCParticipants in this arm receive both interventions - the telephone counseling plus the ACHESS phone application. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| ACHESSSmartphone based additions focused application, encouraging social support | Behavioural | ACHESS, TMC + ACHESS |
| TMCBrief telephone monitoring and counseling | Behavioural | TMC + ACHESS, Telephone Monitoring and Counseling |
Primary outcome
Time Line Follow Back, Percent Heavy Alcohol Use
Time frame: 18 month: months 13 - 18 post baseline
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34859519McKay 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.
- Derived from this study: PubMed 29382367McKay 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.
- Individual participant dataSharing planned: No
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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.
James R. McKay, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
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.