A Community-Based Addiction Rehabilitation Electronic System to Improve Treatment Outcomes in Drug Abusers: Protocol for a Randomized Controlled Trial

Abstract

Introduction: Relapse is very common in drug abusers and contributes to a series of negative consequences. Effective addiction treatment exists but there are some problems in the implementation process. Mobile health (mHealth) offers a potential solution to improving recovery outcome for drug abusers in the community. The research team developed a community-based addiction rehabilitation electronic system (CAREs). The primary aim of this study is to explore whether the integrated rehabilitation based on program CAREs promotes drug abusers to keep abstinence. The secondary aim is to evaluate the impact of CAREs on interaction between drug users and service providers, and on addiction-related physical and social functions. Method and analysis: A randomized controlled trial (RCT) will be conducted. The study is a superiority trial with parallel group design. Seventy drug abusers who are newly ordered to undergo community rehabilitation will be recruited from the community in Shanghai. Participants will be 1:1 randomly assigned to receive integrated community rehabilitation by using CAREs or only receiving routine community rehabilitation for 6 months. Corresponding social workers will provide service and monitor their drug use behavior in accordance with the routine work-flow. Outcomes will be assessed at baseline and in the 6th month. The primary outcome is the performance on illicit drug urine test which will be carried out regularly twice per week during the study period. Secondary study outcomes include longest duration of sustained abstinence, days that participants interact with social workers, and the decrease rate of addiction-related issues severity index. Chi-square tests and ANOVAs will be used to compare characteristics of the members of the two groups. GEE will be used to compare the seven dimensions scores of the ASI between groups. Discussion: The study provides evidence for the feasibility and effectiveness of the "CAREs" system through comparing the results of the intervention group with the control group. This paper describes the design and methodology of the study. Ethics and dissemination: The Ethical Board of SMHC approved the study protocol. All participants will present for the informed consent process. After study completion, the results will be published. Trial Registration: ClinicalTrials.gov NCT03451344, https://ichgcp.net/clinical-trials-registry/NCT03451344.

Keywords: China; community health service; drug abuse; mobile health; rehabilitation.

Figures

Figure 1

Frame diagram of Community-based Addiction Rehabilitation Electronic System (CAREs): (A) Users manage to get immediate support and intervention through CAREs installed in smart phone devices; (B) Users' corresponding social workers can know their clients' current situation by using the web page; (C) All data will be stored in a secure server and double backuped, only doctors and executives are eligible for access.

Figure 2

“Screenshots” taken on a phone device illustrating the user interface: no Regular reminders and Rehabilitation Process Management above for: (1) Regular reminders will only be used when users receive messages from service providers or server; (2) Rehabilitation process involves in some privacy of the patients. For better understanding, we translated some Chinese on the pages into English. CAREs actually is presented in Chinese.

Figure 3

The main “screen” of the service provider web portal. For better understanding, we translated some Chinese on the page into English. The webpage is actually presented in Chinese.

Figure 4

Participant flow diagrams.