A Electronic System to Improve Recovery Outcomes in Patients With Drug Use Disorder

Study Overview
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Brief Summary
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Background: Relapse is very common in patients with illicit drug use disorder and contributes to a series of bad consequences that substantially impact patients' physical and social functions. Due to the limited existence of effective addiction treatment, the majority of patients with drug use disorder could not access help when needing. Mobile health (mHealth) offers a potential solution to improving recovery outcome for patients in community. Objective: This paper is a protocol for a randomized controlled trial (RCT) of a smart phone application called community-based addiction rehabilitation electronic system (CAREs) . This interactive system consists of an APP for clients and a webpage for service providers, with the aim of teaching clients craving and emergency coping skills and helping service providers to improve work efficiency and effectiveness in community. Methods: A randomized controlled trial(RCT) will be conducted. Sixty drug illicit users 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 anti-drug social workers will provide service and monitor participants' drug use behavior in accordance with the routine work-flow. Outcomes will be assessed at baseline and in the 6th month. The primary study outcome is the performance on illicit drug urine test which will be carried on regularly twice per week during the study period. Secondary study outcomes include days that participants interact with anti-drug social workers, and the decrease rate of addiction-related issues severity index.

Official Title
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A Community-based Addiction Rehabilitation Electronic System to Improve Recovery Outcomes in Patients With Drug Use Disorder: Protocol for a Randomized Controlled Trial

Conditions
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Drug Use Disorders, Addiction, Drug

Intervention / Treatment
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* Other: Integrated rehabilitation group
* Other: Community-based rehabilitation group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1)Illicit drug users who are newly ordered to undergoing community-based rehabilitation will be recruited for the study. (2)Candidates are eligible to participated in if they are aged 20 - 50 years (3)Candidates are eligible to participated in if they are meeting the DSM-V (Diagnostic and Statistical Manual of Mental Disorders-V) criteria for substance dependence (4)Candidates are eligible to participated in if they are willing to comply with the relevant requirements of the study including using the mobile app (5)There is no limitation for Gender when recruiting participant. Exclusion Criteria: (1)Illicit drug users who are not newly ordered to undergoing community-based rehabilitation. (2)Candidates' age is less than 20 or older than 50 (3)Candidates does not meet the DSM-V (Diagnostic and Statistical Manual of Mental Disorders-V) criteria for substance dependence (4)Candidates are not able to use the mobile app

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated rehabilitation group<br>Participants will receive the standardized community-based rehabilitation and simultaneously receive a 6-month integrated rehabilitation based on the Community-based Addiction Rehabilitation Electronic System. | Other: Integrated rehabilitation group<br>* Participant in integrated rehabilitation group needs to visit their corresponding social worker and accept illicit drug test every two months. Social worker will help their corresponding client to apply for social benefits accordingly, and provide counseling irregularly if necessary. The integrated rehabilitation group received the standardized community-based rehabilitation described above and simultaneously received a 6-month integrated rehabilitation based on CAREs (Community-based Addiction Rehabilitation Electronic System).CAREs was developed by the department of addiction research in Shanghai Mental Health Center(SMHC), with functions including education, support, psychological intervention and other functions.<br>|
| Active Comparator: Community-based rehabilitation group<br>Participants will receive the standardized community-based rehabilitation. | Other: Community-based rehabilitation group<br>* Participant in community-based rehabilitation group needs to visit their corresponding social worker for six months and accept illicit drug test every two months. Social worker will help their corresponding client to apply for social benefits accordingly, and provide counseling irregularly if necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug urine test | The results of drug urine tests will be examined in overall percentage of drug positive samples. Overall percentage of drug positive samples= the number of positive urine tests results / the number of total urine tests (Subject who does not submit urine samples on time during the intervention period or refuses to submit samples even if he/she is present at the site will be considered as having a positive urine test result). | Up to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interacting with anti-drug social workers | Interaction with anti-drug social workers: The days that participants interact with their corresponding social workers will be collected during the study period. Any phone call, SMS, face-to-face meeting, or communication via CAREs will be considered as interaction happening. | Up to six months | 
| The decrease rate of addiction-related issues severity index | The Chinese translation of the Addiction Severity Index (ASI) that has good reliability and validity in China will be used to assess the severity of addiction at enrollment and 6 months after enrollment. The descent rate will be counted via dividing the minus value between baseline score and 6-month score by baseline score. | Up to six months | 
| Longest duration of sustained abstinence | Longest duration of sustained abstinence will be measured by drug urine tests and will be reported in weeks(the most consecutive weeks of drug negative samples). | Up to six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobile Health, Illicit drug use, Rehabilitation, Community, China