Background: Drug use disorder has high potential for relapse and imposes an enormous burden on public health in China. Since the promulgation of the Anti-drug law in 2008, community-based rehabilitation has become the primary approach to treat drug addiction. However, multiple problems occurred in the implementation process, leading to a low detoxification rate in the community. Mobile health (mHealth) serves as a promising tool to improve the effectiveness and efficiency of community-based rehabilitation. Community-based addiction rehabilitation electronic system (CAREs) is an interactive system for drug users and their assigned social workers. Objective: The study aimed to examine the feasibility and preliminary efficacy of CAREs in community-based rehabilitation from the perspective of drug users and social workers in Shanghai, China. Methods: In this pilot randomized controlled trial, 40 participants were recruited from the community in Shanghai from January to May 2019. Participants randomized to the intervention group (n=20) received CAREs + community-based rehabilitation, while participants in the control group (n=20) received community-based rehabilitation only for 6 months. CAREs provided education, assessment, and SOS (support) functions for drug users. The assigned social workers provided service and monitored drug use behavior as usual except that the social workers in the intervention group could access the webpage end to obtain drug users’ information and fit their routine workflow into CAREs. The primary outcome was the feasibility of CAREs, reflected in the overall proportion and frequency of CAREs features used in both app and webpage end. The secondary outcomes were the effectiveness of CAREs, including the percentage of drug-positive samples, longest period of abstinence, contact times with social workers, and the change of Addiction Severity Index (ASI) from baseline to the 6-month follow-up. Results: The number of participants logged in to the app ranged from 7 to 20 per week, and CAREs had relatively high levels of continued patient use. Drug users preferred assessment and education features in the app end while their social workers showed high levels of use in urine results record and viewing assessment results on the webpage end. After the 6-month intervention, 3.3% (17/520) of samples in the intervention group and 7.5% (39/520) in the control group were drug-positive (F=4.358, P=.04). No significant differences were noted between the control and intervention groups in terms of longest duration of abstinence, number of contact times and ASI composite scores. Conclusions: The study preliminarily demonstrated that with relatively good feasibility and acceptability, CAREs may improve the effectiveness and efficiency of the community-based rehabilitation, which provided instruction for further improvement of the system. Trial Registration: ClinicalTrials.gov NCT03451344; https://clinicaltrials.gov/ct2/show/NCT03451344
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.