Clinical trial NCT05326438: mHealth App for Changing Alcohol Use in Alaska Native American Indian People
Official title: Cultural Innovations for Recovery in Community-Based Learning Environments (CIRCLE) Phase 3: Testing an Online Learning Community Application
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Alaska Native
mHealth app
behavioral interventions
alcohol use disorder
Lead sponsor: Southcentral Foundation
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2022-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: For many people who have trouble with alcohol, peer support - the opportunity to share challenges, problem-solving strategies, and successes with supportive others - can be helpful. Building on Southcentral Foundation's (SCF's) established learning circles for sobriety support, the goal of this study is to culturally adapt and test the acceptability and feasibility of a smartphone app for sobriety support among Alaska Native and American Indian (AN/AI) people. In Aims 1 and 2 of this study, the investigators used input from patients and providers to culturally adapt a commercially available mHealth app for AN/AI people dealing with alcohol misuse. The investigators then merged culturally relevant content (e.g., stories and music) and skill-building modules based on the Community Reinforcement Approach with the existing informational and peer support features of the Connections app, a product of CHESS Health accessible on smartphones and tablets. The investigators will work with up to 125 SCF patients to assess the acceptability, feasibility, and measurable effects of the culturally-adapted app among AN/AI adults 21 and older, relying on questionnaires and interviews to evaluate the app features and utility.

The study's primary outcome is the feasibility and acceptability of the modified CHESS app for AN/AI people as a tool for sobriety. The secondary outcomes are to examine changes in quality of life, alcohol use and problems, self-efficacy in sobriety, and stages of change over the course of using the app. The investigators will also explore whether alcohol use and problems are mediated by frequency of app use, app satisfaction, and alcohol self-efficacy.

Detailed description: Southcentral Foundation (SCF) has a long history of stakeholder engagement, recognizing that engaged patients seek out information, work collaboratively with providers, and are more likely to demonstrate healthy choices and disease-specific self-management behaviors. SCF has used qualitative methods to identify and meet the changing needs of patients. Building on work in Aim 1 and Aim 2, which provided patient feedback about both the Connections app and the intended measurement tools, work in this Aim will include testing a modified version of the app with SCF patients.

The Connections app supports individuals in recovery by reducing relapse and promoting prosocial engagement. The app allows people to track their sobriety, learn new recovery skills, track treatment plans, set reminders, journal about their recovery, and discover helpful videos and testimonials through an extensive resource library. The app also has a "recovery help button" that can be pressed whenever the participant needs urgent help. Examples of Connections content include motivational talks, meditations, addiction recovery speakers, stress management, and anger management. The study team added additional culturally meaningful content, graphics, music, videos, recovery tools, and testimonials. Connections uses a HIPAA and HITRUST compliant interactive peer platform, which allows users to privately message one another and/or participate in group chats. The investigators will utilize the app's mass messaging and group chat capabilities to engage participants in facilitated discussions that are consistent with the policies, services, and treatment philosophies of SCF. The study team will add additional topics such as sobriety, lifestyle changes, cultural content, and skill-building modules based on the Community Reinforcement Approach.

Participants will be asked to utilize the app for at least 3 months, with a 6-month follow-up. Participation in the study will be entirely voluntary and confidential. The investigators plan to recruit no more than 125 AN/AI adults who report a desire to change their alcohol use patterns. The investigators will attempt to recruit at SCF in such a way as to have adequate representation from urban and rural residing customer-owners. Individuals may or may not be engaged in or have a history of treatment services specifically for alcohol use disorders. The investigators will not access customer-owners' medical records for recruitment purposes. The investigators also plan to interview up to 25 participants at the 6-month mark, gathering qualitative data about their experiences using the app.

Data Analytic Plan:

Interviews will be transcribed verbatim and de-identified prior to analysis. Transcripts will be validated for accuracy and uploaded to ATLAS.ti for data management and coding, with categorical demographic information. Members of the qualitative research team will conduct analysis in four iterative steps: (1) familiarizing themselves with the data, (2) generating or applying a priori and emergent codes to the data, (3) searching for thematic patterns, and (4) searching for demographic patterns. Consistency will be maintained through a shared codebook, team coding of selected transcripts, and regular meetings to discuss and resolve discrepancies.

Data analysis of feasibility and acceptability of the Connections app will include descriptive statistics of counts of interaction with the app and total number of days the app was accessed. Bivariate descriptive statistics will be used to examine differences in feasibility by demographics and baseline observations.

Data analysis for survey data will include descriptive statistics and mixed effects modeling to account for correlation of repeated measures within customer-owner participants for quality of life, alcohol use and problems, self-efficacy in sobriety, and stages of change completed in partnership with our external consultants. As part of this analysis, data will be evaluated for selection bias, and measurement error or misclassification bias that are common challenges in repeated measures and longitudinal public health datasets.

Eligibility criteria: Inclusion Criteria (self-reported as):

* Alaska Native/American Indian;
* ≥ 21 years of age;
* Having a desire to change drinking behavior;
* Receiving services at Southcentral Foundation and reside in the Anchorage Service Unit (urban and rural);
* English-speaking;
* Having access to a smartphone or tablet.

Exclusion Criteria (self-reported as):

* Not Alaska Native/American Indian;
* Non-English speaking;
* Having a medical or severe psychiatric condition that the PIs determine would make it difficult for the individual to use the app or participate in the interview;
* Not having access to a smartphone or tablet (e.g., iPad, Kindle Fire, etc.).

Primary outcomes:
measure: Feasibility and acceptability of the app
timeFrame: 6 months post app use
measure: Changes in alcohol and drug use over time
timeFrame: Baseline, 3 months after using app, 6 months after using app
measure: Changes in self-efficacy to avoid drinking
timeFrame: Baseline, 3 months after using app, 6 months after using app
measure: Changes in alcohol associated problems
timeFrame: Baseline, 3 months after using app, 6 months after using app
measure: Changes in motivation to change alcohol use
timeFrame: Baseline, 3 months after using app, 6 months after using app
measure: Changes in quality of life scores
timeFrame: Baseline, 3 months after using app, 6 months after using app
measure: Changes in positive and negative affect scores
timeFrame: Baseline, 3 months after using app, 6 months after using app
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Southcentral Foundation
state: Alaska
Study officials:
affiliation: Southcentral Foundation
name: Ann D Collier, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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