Assessment of feasibility and accessibility of digitalized aftercare for drug addicts who completed residential drug rehabilitation in Sri Lanka
| ISRCTN | ISRCTN90955874 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90955874 |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | AHEAD DOR (R2) No. 06 |
- Submission date
- 28/05/2023
- Registration date
- 31/05/2023
- Last edited
- 31/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
"Aftercare" refers to the interventions that assist individuals with substance use disorder (drug addiction) who have completed the treatment or rehabilitation for reintegration into society. Aftercare will facilitate a favorable and safe environment for sustaining the substance-free state and also it provides interactive platforms to overcome the issues and problems associated with abstinence and recovery. However, the aftercare treatment provided in Sri Lanka has certain limitations, and individuals who have undergone residential rehabilitation require an evidence-based aftercare intervention that addresses these limitations. The study aims to assess the feasibility and acceptability of the digitalized aftercare (SECOND WIND Mobile Application) for drug addicts who completed residential drug rehabilitation in Sri Lanka.
Who can participate?
Volunteer adults with substance use disorder who have completed the residential rehabilitation treatment program can participate in the study
What does the study involve? (for participants)
Participants will be randomly allocated into an intervention group or control group. The intervention group will receive the digitalized aftercare via the SECOND WIND mobile application while the control group will receive the existing aftercare services facilitated by physical visits and contacts over the telephone. This mobile application offers a comprehensive suite of features aimed at supporting recovery, including client-counselor communication, a platform for educational information on relapse prevention via lectures, videos, and testimonials, an SOS emergency contact feature, engaging family members for treatment continuum and setting up short term and long-term goals. The digitalized aftercare treatment will span a three-month period.
What are the possible benefits and risks of participating?
By participating in this study, individuals allocated to the intervention group will receive aftercare via a digitalized and safe platform. Individuals allocated to the control group will receive the usual aftercare and if they are willing to experience the digitalized aftercare via the SECOND WIND mobile application they also will be provided the opportunity to participate after the study period. There is a potential risk of exposing confidential information in the event of hacking or unauthorized access for the SECOND WIND mobile application.
Since this is a digital intervention, the likelihood of any serious adverse events (SAEs) in this intervention is very minimal as it is a digitized mobile application-based intervention. Provisions for modifications or termination of the trial will be provided if safety concerns arise for the participants. Any such modifications or termination of the trial will be informed to the ethics review committee, director of the rehabilitation center, funding body and the participants. Participants will be provided with the provisions for re-consenting after any change of the approved proposal.
Where is the study run from?
The study participants will be enrolled from 3 selected rehabilitation centers namely Talangama Prevention, Treatment & Rehabilitation Centre located in Colombo, Nawadiganthaya Youth Prevention, Treatment & Rehabilitation Centre in Urapola, Nittambuwa, and Galle Youth Prevention, Treatment & Rehabilitation Centre in Unawatuna, Galle which is governed by the National Dangerous Drugs Control Board, of Sri Lanka.
When is the study starting and how long is it expected to run for?
January 2022 to December 2023
Who is funding the study?
This study is funded by the Accelerating Higher Education Expansion and Development (AHEAD) Operation of the Ministry of Higher Education, Technology, and Innovation (Grant number HEI DOR (R2) No. 06).
Who is the main contact?
Akila R. Jayamaha (Principal Investigator), akila@kiu.ac.lk
Contact information
Principal Investigator
KAATSU International (Private) University (KIU) Sri Lanka
No 249/1 Malabe Rd
Battaramulla
10120
Sri Lanka
 ORCID ID |
0000-0002-3372-4537 |
|---|---|
| Phone | +94777614918 |
| akila@kiu.ac.lk |
Scientific
KAATSU International (Private) University (KIU) Sri Lanka
No 249/1 Malabe Rd
Battaramulla
10120
Sri Lanka
| ORCID ID |
0000-0002-6971-674X |
|---|---|
| Phone | +94719237468 |
| nadeeka@kiu.ac.lk |
Public
KAATSU International (Private) University (KIU) Sri Lanka
No 249/1 Malabe Rd
Battaramulla
10120
Sri Lanka
| ORCID ID |
0000-0002-7581-7838 |
|---|---|
| Phone | +94705539419 |
| caroline@kiu.ac.lk |
Study information
| Study design | Multicenter single-blind randomized controlled feasibility trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Built environment/local authority, Other |
| Study type | Other, Prevention, Quality of life, Safety |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Feasibility and acceptability of digitalized aftercare (SECOND WIND mobile application) for individuals with substance use disorder who completed residential drug rehabilitation in Sri Lanka: A randomized control feasibility trial |
| Study acronym | SECOND WIND |
| Study hypothesis | SECOND WIND mobile application is a feasible and acceptable digitalized aftercare for individuals with substance use disorder (SUD) who completed residential drug rehabilitation in Sri Lanka |
| Ethics approval(s) | Approved 15/01/2023, Ethics Review Committee of KIU, (No 249/1 Malabe Rd, Battaramulla, Sri Lanka; +94 11 2 741 878; erc@kiu.ac.lk), ref: KIU/ERC/22/102 |
| Condition | Prevention of relapse into substance use behavior in individuals who have undergone residential rehabilitation treatment |
| Intervention | Individuals with substance use disorder who completed the residential rehabilitation will be 1:1 randomized into an intervention group or control group using Sealed Envelope software [https://www.sealedenvelope.com/]. The intervention group will receive the digitalized aftercare via SECOND WIND mobile application (https://play.google.com/store/apps/details?id=com.fishifox.secondwindlk&pli=1) while control group will receive the existing aftercare services facilitated by physical visits and contacts over the telephone. SECOND WIND is a mobile application created to provide digitalized aftercare for individuals with substance use disorder who have successfully completed residential rehabilitation. This mobile application offers a comprehensive suite of features aimed at supporting recovery, including client-counselor communication, a platform for educational information on relapse prevention via lectures, videos, and testimonials, an SOS emergency contact feature, engaging family members for treatment continuum and setting up short term and long-term goals. The digitalized aftercare treatment will span a three-month period. Individuals belonging to both groups were assessed monthly for lapses and relapses of substance use behavior during the three-month period. Focus groups and in-depth interviews will be conducted to assess the acceptability and feasibility of SECOND WIND mobile application among the stakeholders at the end of the three-month period. |
| Intervention type | Other |
| Primary outcome measure | The primary outcome of the trial will be assessing the feasibility and acceptability of digitalized aftercare (SECOND WIND mobile application) for individuals with substance use disorder (clients) who completed residential drug rehabilitation in Sri Lanka. The feasibility of enrolling clients, counselors, and outreach officers into the SECOND WIND mobile application will be assessed using a screening log, at the initial stage of the study. The feasibility of the digitalized follow-up will be assessed using the System Usability Scale (SUS) and the metadata log files of the SECOND WIND mobile application during the follow-up period. The acceptability of the stakeholders (clients, counselors, and outreach officers) will be assessed via in-depth interviews at the end of the follow-up period. |
| Secondary outcome measures | 1. Lapse and relapses of substance use behavior will be measured using interviews at the end of the follow-up period 2. Quality of life, will be measured using EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) at baseline and end of the follow-up period 3. Addiction wellness will be measured using the Recovery Capital Index (RCI) at baseline and end of the follow-up period 4. Severity of consequences related drug abuse will be measured using the Drug Abuse Screening Test (DAST-10) at baseline and end of the follow-up period. |
| Overall study start date | 01/01/2022 |
| Overall study end date | 31/12/2023 |
Eligibility
| Participant type(s) | Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Participant inclusion criteria | Volunteer adults with substance use disorder who have completed the residential rehabilitation treatment will be included in the study. |
| Participant exclusion criteria | Participants will be excluded from the study if they exhibit severe cognitive impairment or have acute psychiatric conditions, or if they plan to travel overseas after completing their residential rehabilitation treatment program/ not have access to a smartphone device. |
| Recruitment start date | 01/06/2023 |
| Recruitment end date | 01/09/2023 |
Locations
Countries of recruitment
- Sri Lanka
Study participating centres
Nittambuwa
11880
Sri Lanka
Galle
80000
Sri Lanka
Thalangama
10120
Sri Lanka
Sponsor information
University/education
No 249/1 Malabe Rd
Battaramulla
10120
Sri Lanka
| Phone | +94112741878 |
|---|---|
| info@kiu.ac.lk | |
| Website | https://www.kiu.ac.lk/ |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed Journal |
| IPD sharing plan | The data sets generated during and/ or analysed during the current study are not expected to be made available due to ethical agreement of maintaining confidentiality of individual participant data. |
Editorial Notes
31/05/2023: Trial's existence confirmed by the Ethics Review Committee of Kaatsu Highly Advanced Medical Technology Training Center (Sri Lanka).
