The effectiveness of applying continuous care model on lapse and craving of patients that are treated with methadone maintenance therapy in Razi Educational and Treatment Center of Urmia 2016
Objective: To determine the effectiveness of applying continuous care model on lapse and craving of patients that are treated with methadone maintenance therapy in Razi Educational and Treatment Center of Urmia in 2016.
Design: The current study is an experimental study. The population of the study is the drug-dependent patients who are treated with methadone maintenance therapy in Razi Educational and Treatment Center of Urmia. The Inclusion criteria for this study are: being between 18-48 years old, the diagnostic criteria for opioid dependence, according to psychiatrist, passing at least 3 months of being treated with methadone maintenance therapy and residence in the city of Urmia and the exclusion criteria are psychological disorders that require hospitalization, use of antipsychotics and anticonvulsants at the time of entering the study and lack of willingness or ability to participate in the continuous care meetings. The sample size is 95 persons, which will be randomly assigned to one intervention group and one control group.For randomization of intervention and control groups we use sealed envelopes that containing the names of intervention and control groups. Intervention: We will implement continuous care model. This model will comprise of four steps: Orientation, Sensitization, Control and Evaluation. This model will be executed on the intervention group. Each patient will participate in four sessions individually. During the study, the patients will be under continuous care directly or with a phone call by the end of three months. The control group only will receive the current care. Main outcome variable: Reduction of lapse and craving of patients
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042816564N6
Registration date:2016-06-08, 1395/03/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-08, 1395/03/19
Registrant information
Name
Molood Radfar
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1275 4961
Email address
radfar.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Urmia University of Medical Science
Expected recruitment start date
2016-05-30, 1395/03/10
Expected recruitment end date
2016-08-31, 1395/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of applying continuous care model on lapse and craving of patients that are treated with methadone maintenance therapy in Razi Educational and Treatment Center of Urmia 2016
Public title
The effectiveness of applying continuous care model on lapse and craving of patients that treated are with methadone maintenance therapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Being between 18-48 years old, the diagnostic criteria for opioid dependence, according to psychiatrist, passing at least 3 months of being treated with methadone maintenance therapy and residence in the city of Urmia
Exclusion criteria: Psychological disorders that require hospitalization, use of antipsychotics and anticonvulsants at the time of entering the study and lack of willingness or ability to participate in the continuous care meetings
Age
From 18 years old to 48 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
95
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences and Health Serviceو, Next Emergency Center, Resalat Blvd
City
Urmia
Postal code
5714783734
Approval date
2016-05-18, 1395/02/29
Ethics committee reference number
ir.umsu.rec.1395.95
Health conditions studied
1
Description of health condition studied
Opioid Dependency
ICD-10 code
ّF11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
2
Description of health condition studied
Cannabis drug dependence
ICD-10 code
F12
ICD-10 code description
Mental and behavioural disorders due to use of cannabinoids
3
Description of health condition studied
Sedative or hypnotic drug dependence
ICD-10 code
F13
ICD-10 code description
Mental and behavioural disorders due to use of sedatives or hypnotics
4
Description of health condition studied
Cocaine dependence
ICD-10 code
F14
ICD-10 code description
Mental and behavioural disorders due to use of cocaine
5
Description of health condition studied
Hallucinogenic drug dependence
ICD-10 code
ّّّF16
ICD-10 code description
Mental and behavioural disorders due to use of hallucinogens
Primary outcomes
1
Description
lapse
Timepoint
During the 3 months and 3 months before the study intervention
Method of measurement
Nominal-Lapse and absence check list
2
Description
Craving
Timepoint
before and during the 3 months of intervention
Method of measurement
Craving Questionnaire after leaving
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Continuous Care Model will be implemented on intervention group over a period of 3 months. This model consists of 4 stages which will be done individually. Orientation stage: This stage involves introduction, indicating obviously the objectives and expectations of nurse in the study, determining the expectations of patient, complete the consent, agreement and determining the appointment time and telephone meeting. This stage will be implemented for one session about 20 to 40 minutes. Sensitization stage: At this stage the aim is to involve the patient in the implementation of continuous care and understand the nature of addiction. And also, care consultation will be given about addiction features, substances withdrawal and intoxication signs, how to prevent them, tempting and risk factors and the need to avoid them, the need to continue the treatment and timely and regular visits to addiction treatment center, the importance of physical activity and sport and distraction, healthy relationships and participate in social activities, encourage to use the experiences of treated people, the necessity of leaving bad habits and the importance of continued health behaviors. Counseling and continuous care lead to increase patients’ confidence. Control stage: In this stage, the goal is to change fundamentally and persistently the health behaviors in order to protect and promote leaving state. Then, we will continue to have face to face and telephone counseling and control care needs, the process of care, new problems, persistence of health behaviors, and adherence to treatment. Evaluation stage: That is the fourth and final step which will be considered in all stages. At this stage, care process, successes and failures and respective indices y filling out the questionnaires and recorded clinical findings will be evaluated.
Category
Prevention
2
Description
Orientation stages will be implemented as well as for the control group but will differ in terms of time and expectations and future programs slightly. Because the purpose of the orientation stage to the control group is only encouraging the cooperation in implementing periodical controls to complete the intended data. This group will be controlled and treated with usual and ordinary care approaches that are available in the center.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Razi Academic Psychiatric Hospital
Full name of responsible person
Dr. Rahim Khalilzadeh
Street address
km 3 of salmas road-Razi Academic Psychiatric Hospital-Urmia
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia University of Medical Sciences, Vice Chancellor of Research
Full name of responsible person
vice chancellor for research,.urmia University of Medical Sciences
Street address
Next Emergency Center, Resalat Blvd Urmia, University of Medical Sciences and Health Service
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia University of Medical Sciences, Vice Chancellor of Research