Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02681406 |
| Other study ID # |
819881 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2014 |
| Est. completion date |
March 15, 2020 |
Study information
| Verified date |
March 2022 |
| Source |
University of Pennsylvania |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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).
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.
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.
