AA on Drug Abusers by Nursing Students

Study Overview
=================
Brief Summary
-----------------
Drug abuse is a serious public health issue. Despite the serious consequences of drug abuse, there are around 2000 new cases reported by drug abusers each year. There is growing evidence of the use of auricular acupressure (AA), a traditional Chinese medicine (TCM) treatment modality, in reducing withdrawal symptoms among drug abusers. This study aims to investigate the feasibility and effectiveness of training nursing students to deliver brief education on AA on drug abusers.

Detailed Description
-----------------
A 2-arm feasibility cluster RCT will be conducted in the 80 drug abusers from 7 substance abuse clinics in Hong Kong Hospital Authority following the CONSORT statement. The intervention group will receive AA intervention individually from trained nursing students. The control group will individually receive a 5-minute seminar delivered by a research assistant.

Official Title
-----------------
Around the Turn: A Feasibility Cluster Randomized Controlled Trial of Using Auricular Acupressure to Abstain From Drug Abuse Through Training Nursing Students

Conditions
-----------------
Drug Abuse

Intervention / Treatment
-----------------
* Other: AA group
* Other: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 or above Have reported to abuse drugs within the past 30 days Can communicate in Cantonese and read Chinese Exclusion Criteria: Unstable mental conditions that are not suitable for the intervention Receiving acupuncture or acupressure treatment currently or in the previous 30 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AA group<br>AA for drug abusers. | Other: AA group<br>* Participants will individually receive a 5-minute AA education delivered verbally at his/her respective clinic by a trained nursing student interventionist in addition to the usual scheduled follow-ups and activities at clinics.<br>|
| Placebo Comparator: Control group<br>Routine seminar for drug abusers. | Other: Control group<br>* To mimic the time and attention spent, the control group will individually receive a 5-minute seminar delivered by an RA.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening rate | calculated as the number of abusers screened at participated clinics divided by number of abusers at participated clinics during the recruitment period. | at the 6-month follow-up | 
| Eligibility rate | calculated by dividing the number of abusers who are eligible by the number who are screened. | at the 6-month follow-up | 
| Consent rate | calculated by dividing the number of abusers who consent to join the study by the number who are eligible. | at the 6-month follow-up | 
| Randomization rate | calculated by dividing the number of abusers who are randomized into intervention and control groups by those who provide consent. | at the 6-month follow-up | 
| Attendance rate | calculated by dividing the number of abusers who complete the intervention by those who are randomized. | at the 6-month follow-up | 
| Retention rate | : calculated by dividing the number of abusers who remain in the study by those who are randomized. Retention rates for the intervention and control groups will be calculated at each follow-up. | at the 6-month follow-up | 
| Adherence to intervention protocol | calculated by dividing the number of abusers who follow the intervention protocol by those who are randomized. | at the 6-month follow-up | 
| Complete rate | calculated by dividing the number of abusers who returned questionnaires by the number of questionnaires distributed. This will be calculated by groups at baseline and each follow-up. | at the 6-month follow-up | 
| Missing data | calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values. | at the 6-month follow-up | 
| Adverse events | defined as unfavorable and unintended events that are not present at baseline, or appear to have worsened during the study. | at the 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported abstinence | Self-reported drug abstinence at last 30 days. | at the 6-month follow-up | 
| Abstinence with urine testing | . Those who report no drug abuse within the past 30 days at the 6-month follow-up will be further invited for urine testing. | at the 6-month follow-up | 
| Self-reported levels of craving | The Chinese version of the 3-item craving scale will be used to measure abusers' self-reported levels of craving. | at the 6-month follow-up | 
| Anxiety | Generalized anxiety disorder-7 will be used to measure the severity of self-reported anxiety. | at the 6-month follow-up | 
| Quality of life measures by short-Form Six-Dimension | Short-Form Six-Dimension will be used to assess abusers' quality of life.It contains six dimensions of health. The Chinese version is well validated in Hong Kong. | at the 6-month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Auricular Acupressure, Nursing Students