NCT03954184

Brief Summary

This research will test a technology adoption framework to increase use of the A-CHESS smartphone app. The project, based in Iowa, will compare a control condition (using a typical product training approach to software implementation that includes user tutorials and instruction on administrative and clinical protocols, followed by access to on-line support) to the typical product training combined with NIATx-TI. Terms - A-CHESS: Addiction Comprehensive Health Enhancement Support System NIATx-TI: Network for the Improvement of Addiction Treatment-Technology Implementation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23,659

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

49 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 3, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 7, 2025

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

3.8 years

First QC Date

May 10, 2019

Results QC Date

September 16, 2024

Last Update Submit

February 6, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Reach: As Assessed by the Mean Number of Clinics With Participants Who Download the A-CHESS App

    The mean number of clinics with patients who download the A-CHESS app will be obtained monthly during the study via the A-CHESS server and Iowa Department of Public Health (IDPH) data.

    45 months

  • Reach: As Assessed by the Number of Days That Participants Use the A-CHESS

    The frequency of use of A-CHESS by each participant will be obtained monthly during the study via the A-CHESS server and Iowa Department of Public Health (IDPH) data.

    45 months

Secondary Outcomes (7)

  • Effectiveness of A-CHESS as Assessed by the Retention Rate of Eligible Participants.

    Collected monthly during months 13 - 45

  • Adoption: Number of Days Each Counselor Used the A-CHESS

    45 months

  • Adoption - The Percentage of Counselors Using A-CHESS Will be Assessed Via the Organizational Survey and A-CHESS Logs

    Collected twice during study; starting M22 - 31 and M35-44

  • A-CHESS/NIATx Implementation Fidelity (Survey)

    Collected twice during study; approx. M14 - 25 and M32 - 43

  • Organizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey)

    Collected twice during study; approx. M14 - 25 and M32 - 43

  • +2 more secondary outcomes

Other Outcomes (2)

  • Supplement 1 - Understand Impact of ACHESS on pt Anxiety and Loneliness During COVID-19 Pandemic

    M34-37

  • Supplement 2 - Understand How Treatment Organizations and Staff Used ACHESS During COVID Pandemic

    M34-37

Study Arms (2)

TAU/Control

NO INTERVENTION

Sites in the Treatment as Usual (TAU)/Control Arm will receive product training/online support. Sites in the TAU/Control Arm will participate in a one-day product implementation or training session.

NIATx-TI Framework

EXPERIMENTAL

Sites in the NIATx-TI Arm will receive product training/online support, and training in the NIATx-TI framework. The NIATx-TI framework will include a pre-implementation (planning) phase, and post-implementation (problem-solving) phase, with training delivered by a NIATx-TI coach.

Behavioral: NIATx-TI with Product Training/On-line Support

Interventions

NIATx-TI framework includes the product training as well as a preimplementation phase and a post-implementation phase. A NIATx-TI coach will provide the training for this arm. The coach will also assist the organizations with applying the NIATx-TI framework.

NIATx-TI Framework

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be 18+ years old
  • Understand English
  • Have a SUD diagnosis
  • Have access to a smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (49)

Zion Recovery Services

Adel, Iowa, 50003, United States

Location

Prairie Ridge Integrated Behavioral Healthcare

Algona, Iowa, 50511, United States

Location

Community and Family Resources

Ames, Iowa, 50010, United States

Location

Area Substance Abuse Council

Anamosa, Iowa, 53305, United States

Location

UCS Healthcare

Ankeny, Iowa, 50021, United States

Location

Zion Recovery Services

Atlantic, Iowa, 50022, United States

Location

Area Substance Abuse Council

Belle Plaine, Iowa, 52208, United States

Location

Community and Family Resources

Boone, Iowa, 50036, United States

Location

Alcohol and Drug Dependency Services (ADDS)

Burlington, Iowa, 52601, United States

Location

Area Substance Abuse Council

Cedar Rapids, Iowa, 52404, United States

Location

Prairie Ridge Integrated Behavioral Healthcare

Charles City, Iowa, 50616, United States

Location

Jackson Recovery Centers

Cherokee, Iowa, 51012, United States

Location

Prelude Behavioral Health Services

Clarence, Iowa, 52216, United States

Location

Zion Recovery Services

Clarinda, Iowa, 51632, United States

Location

Community and Family Resources

Clarion, Iowa, 50525, United States

Location

Heartland Family Services

Council Bluffs, Iowa, 51503, United States

Location

Area Substance Abuse Council

De Witt, Iowa, 52742, United States

Location

Jackson Recovery Centers

Denison, Iowa, 51442, United States

Location

UCS Healthcare

Des Moines, Iowa, 50310, United States

Location

House of Mercy

Des Moines, Iowa, 50314, United States

Location

Prelude Behavioral Health Services

Des Moines, Iowa, 50317, United States

Location

Substance Abuse Services Center

Dubuque, Iowa, 52001, United States

Location

Prairie Ridge Integrated Behavioral Healthcare

Forest City, Iowa, 50436, United States

Location

Community and Family Resources

Fort Dodge, Iowa, 50501, United States

Location

Heartland Family Services

Glenwood, Iowa, 51534, United States

Location

Zion Recovery Services

Greenfield, Iowa, 50849, United States

Location

Prairie Ridge Integrated Behavioral Healthcare

Hampton, Iowa, 50441, United States

Location

Community and Family Resources

Humboldt, Iowa, 50548, United States

Location

House of Mercy

Indianola, Iowa, 50125, United States

Location

Prelude Behavioral Services

Iowa City, Iowa, 52240, United States

Location

ADDS

Keokuk, Iowa, 52362, United States

Location

UCS Healthcare

Knoxville, Iowa, 50138, United States

Location

Jackson Recovery Centers

Le Mars, Iowa, 51031, United States

Location

Heartland Family Services

Logan, Iowa, 51546, United States

Location

Area Substance Abuse Council

Maquoketa, Iowa, 52060, United States

Location

Prelude Behavioral Health Services

Marengo, Iowa, 52301, United States

Location

Prairie Ridge Integrated Behavioral Healthcare

Mason City, Iowa, 50401, United States

Location

ADDS

Mount Pleasant, Iowa, 52641, United States

Location

House of Mercy

Newton, Iowa, 50208, United States

Location

Zion Recovery Services

Perry, Iowa, 50220, United States

Location

Community and Family Resources

Pocahontas, Iowa, 50574, United States

Location

Zion Recovery Services

Red Oak, Iowa, 51566, United States

Location

Community and Family Resources

Rockwell City, Iowa, 50579, United States

Location

Zion Recovery Services

Shenandoah, Iowa, 51601, United States

Location

Jackson Recovery Centers

Sioux City, Iowa, 51101, United States

Location

Prelude Behavioral Services

Tipton, Iowa, 52772, United States

Location

Area Substance ABuse Council

Vinton, Iowa, 52349, United States

Location

ADDS

Wapello, Iowa, 52632, United States

Location

Community and Family Resources

Webster City, Iowa, 50595, United States

Location

Related Publications (4)

  • Fleddermann K, Molfenter T, Vjorn O, Horst J, Hulsey J, Kelly B, Zawislak K, Gustafson DH, Gicquelais RE. Patient Preferences for Mobile Health Applications to Support Recovery. J Addict Med. 2023 Jul-Aug 01;17(4):394-400. doi: 10.1097/ADM.0000000000001137. Epub 2023 Jan 18.

  • Fleddermann K, Molfenter T, Jacobson N, Horst J, Roosa MR, Boss D, Ross JC, Preuss E, Gustafson DH. Clinician Perspectives on Barriers and Facilitators to Implementing e-Health Technology in Substance Use Disorder (SUD) Treatment Facilities. Subst Abuse. 2021 Oct 26;15:11782218211053360. doi: 10.1177/11782218211053360. eCollection 2021.

  • Gustafson D Sr, Horst J, Boss D, Fleddermann K, Jacobson N, Roosa M, Ross JC, Gicquelais R, Vjorn O, Siegler T, Molfenter T. Implementation of Smartphone Systems to Improve Quality of Life for People With Substance Use Disorder: Interim Report on a Randomized Controlled Trial. JMIR Hum Factors. 2022 Jul 14;9(3):e35125. doi: 10.2196/35125.

  • White VM, Molfenter T, Gustafson DH, Horst J, Greller R, Gustafson DH Jr, Kim JS, Preuss E, Cody O, Pisitthakarm P, Toy A. NIATx-TI versus typical product training on e-health technology implementation: a clustered randomized controlled trial study protocol. Implement Sci. 2020 Oct 23;15(1):94. doi: 10.1186/s13012-020-01053-4.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Todd Molfenter, PhD
Organization
University of Wisconsin - Madison

Study Officials

  • Todd Molfenter, Ph.D.

    University of Wisconisn-Madison

    PRINCIPAL INVESTIGATOR
  • David Gustafson, Ph.D.

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2019

First Posted

May 17, 2019

Study Start

September 3, 2019

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

February 7, 2025

Results First Posted

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations