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Smartphone Based Continuing Care for Alcohol

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACHESS
TMC
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Treatment as Usual

Telephone Monitoring and Counseling

ACHESS

TMC + ACHESS

Arm Description

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.

TMC - participants receive brief (20 minute) telephone counseling once weekly, then biweekly, etc for 12 months.

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.

Participants in this arm receive both interventions - the telephone counseling plus the ACHESS phone application.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 9, 2016
Last Updated
March 8, 2022
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02681406
Brief Title
Smartphone Based Continuing Care for Alcohol
Official Title
Impact of Enhancements to Smartphone Based Continuing Care for Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
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.
Arm Title
Telephone Monitoring and Counseling
Arm Type
Experimental
Arm Description
TMC - participants receive brief (20 minute) telephone counseling once weekly, then biweekly, etc for 12 months.
Arm Title
ACHESS
Arm Type
Experimental
Arm Description
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.
Arm Title
TMC + ACHESS
Arm Type
Experimental
Arm Description
Participants in this arm receive both interventions - the telephone counseling plus the ACHESS phone application.
Intervention Type
Behavioral
Intervention Name(s)
ACHESS
Intervention Description
Smartphone based additions focused application, encouraging social support
Intervention Type
Behavioral
Intervention Name(s)
TMC
Intervention Description
Brief telephone monitoring and counseling
Primary Outcome Measure Information:
Title
Time Line Follow Back, Percent Heavy Alcohol Use
Description
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.
Time Frame
18 month: months 13 - 18 post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James R. McKay, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29382367
Citation
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.
Results Reference
derived

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Smartphone Based Continuing Care for Alcohol

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