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Substance-Related DisordersTASUNCT02930577

Treatment Adherence in Substance Users

An observational study of Substance-Related Disorders, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the factors associated with treatment adherence in substance users. Differences in the level of adherence to treatment according to patient-related factors, addiction and treatment are analyzed. The individual effect of each factor on treatment adherence is assessed. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Substance-Related Disorders
How many people
216 participants
Where
No sites listed yet
Study dates
Oct 2015to Aug 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Substance users who completed addiction treatment between November 2013 and January 2016.

Who may be able to join

  • Clinical diagnosis of Substance-Related Disorders
  • Treatment for drug dependency

Who cannot join

  • Admission for detoxification treatment.

About this study

Official title: Factors Associated With Treatment Adherence in Substance Users

This study evaluates the factors associated with treatment adherence in substance users. Differences in the level of adherence to treatment according to patient-related factors, addiction and treatment are analyzed. The individual effect of each factor on treatment adherence is assessed.

Read the detailed description

INTRODUCTION: Treatment dropout is an unsolved problem in the addiction process which makes frequent the failure of the addiction therapy. Research shows that the majority of dropouts occur during the first weeks of the treatment. These are the most serious ones because they have the worst prognosis. Some factors, related to the patients and the therapy, have been associated with treatment dropout but the diversity of studied variables, the heterogeneity of patients and the sparse population of many studies, hampers external validity and comparison of results.

OBJECTIVES: Analyze the treatment adherence of an outpatient treatment program for addicts. Identify factors associated with treatment adherence in substance users.

MATERIAL AND METHODS: Observational, analytical, longitudinal and retrospective study in substance users who completed addiction treatment between November 2013 and January 2016. Treatment adherence is measured in terms of medical discharge, regular attendance at activities and success in the NOC indicators. Differences in the level of adherence to treatment according to patient-related factors, addiction and treatment are analyzed. The individual effect of each factor on treatment adherence is assessed.

Keywords
treatment adherence, outpatient treatment, drug dependence
Medical subject headings
Substance-Related Disorders, Treatment Adherence and Compliance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. treatment adherence

    Good adherence: if the patient complete the treatment, attends health professionals sessions and/or gets a sufficient score in objectives nursing.

    Bad-adherence: if the patient not complete the treatment.

    Measured: two month

Secondary outcomes (8)

  1. gender

    options: male or female.

    Measured: two months

  2. age

    Measured: two months

  3. work situation

    options: unemployed, worker, pensioner or student.

    Measured: two months

  4. cohabitation

    options: alone, with parents or with the couple and sons

    Measured: two months

  5. family support

    options: no support, support, support and groups

    Measured: two months

  6. all mental disorders of DSM-IV (Diagnostic and Statistical Manual of mental Disorders)

    Measured: two months

  7. all drugs

    Measured: two months

  8. Self-esteem level according to the Rosenberg Self-Esteem questionnaire.

    options: high, medium or low self-esteem level.

    Measured: two months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionMay 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Retrospective
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02930577
Sponsor's protocol ID
IIBSP-TOX-2015-71
Acronym
TASU
Status last verified
Oct 2016
First submitted
26 Aug 2016
Last updated
12 Oct 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • López Goñi JJ, Fernández-Montalvo J, Arteaga A. El abandono (dropout) en el Tratamiento de la Adicción: Explorando las Características de los Pacientes. Am J Addict. 2011;(21):78-85.

  • Zamora YR. Predicción del abandono del tratamiento en adictos mediante el cuestionario VPA-30. Revista del Hospital Psiquiátrico de La Habana. 2014;11(2).

  • Sanchez-Hervas E, Secades-Villa R, Gomez FJ, Romaguera FZ, Garcia-Rodriguez O, Yanez EM, Frances MC, Fernandez GG. [Treatment dropout in cocaine addicts]. Adicciones. 2010;22(1):59-64. Spanish.

    PubMed 20300715

  • Valero-Aguayo L, Ortiz-Tallo M, Parra-García MM, Jiménez-Guerra M. Valoración de resultados y perfil psicosocial de un programa de rehabilitación de personas con drogodependencias. Anales de Psicología. 2013;29(1):38-47.

  • Fernández-Montalvo J, López Goñi JJ, Landa N, Illescas C, Lorea, I, Zarzuela, A. Trastornos de personalidad y abandonos terapéuticos en pacientes adictos: resultados en una comunidad terapéutica. Int J Clin Health Psychol. 2004; 4(2): 271-283.

  • Llinares Pellicer MC, Palau Munoz C, Albiach Catala C, Santos Diez P. [Predictive variables of adherence to treatment in alcoholics]. Actas Esp Psiquiatr. 2002 Nov-Dec;30(6):370-5. Spanish.

    PubMed 12487947

  • Garcia-Rodriguez O, Secades-Villa R, Alvarez Rodriguez H, Rio Rodriguez A, Fernandez-Hermida JR, Carballo JL, Errasti Perez JM, Al-Halabi Diaz S. [Effect of incentives on retention in an outpatient treatment for cocaine addicts]. Psicothema. 2007 Feb;19(1):134-9. Spanish.

    PubMed 17295995

  • Albiach C, Llinares MC, Palau C, Santos P. Adherencia en heroinómanos: la potencia predictiva de los estadios de cambio evaluados durante la admisión al tratamiento. Adicciones. 2000;12(2):225-234.

  • Olmos-Espinosa R, Madoz-Gúrpide A, Ochoa E. Situación al año de los adictos a opiáceos que siguieron tratamiento ambulatorio tras desintoxicación hospitalaria. Adicciones. 2001;13(2):173-8.

  • Albiach C, Palau C, Llinares C, Santos P. Estudio sobre la adherencia al tratamiento en sujetos con adicción a diferentes sustancias que acuden a servicios ambulatorios. En: V Encuentro Nacional sobre drogodependencias y su enfoque comunitario; 1998; Chiclana de la Frontera, Cádiz, p. 57-70.

  • Herrera JM, Barberán M, Yumar T. La adherencia al tratamiento en una Unidad de Atención a las Drogodependencias (UAD). Trabajo Social y Salud. 2008; (61):155-182.

  • López-Goñi JJ, Fernández-Montalvo J, Illescas C, Landa N, Lorea I. Razones para el abandono del tratamiento en una comunidad terapéutica. Trastor Adict. 2008;10(2):104-111.

  • Domínguez-Martín AL, Miranda-Estribí MD, Pedrero-Pérez EJ, Pérez-López M, Puerta-García C. Estudio de las causas de abandono del tratamiento en un centro de atención a drogodependientes. Trastor Adict. 2008;10(2):112-120.

  • Silva Lento AF, Cerqueira AM, Rocha Costa OC. Programa de deshabituación. ¿Cuáles son los factores que llevan al dropout? Revista española de drogodependencias. 2004; (1):62-70.

  • Roncero C, Rodriguez-Cintas L, Barral C, Fuste G, Daigre C, Ramos-Quiroga JA, Casas M. Treatment adherence to treatment in substance users referred from Psychiatric Emergency service to outpatient treatment. Actas Esp Psiquiatr. 2012 Mar-Apr;40(2):63-9. Epub 2012 Mar 1.

    PubMed 22508071

Questions about this trial

What is this clinical trial studying?

An observational study of Substance-Related Disorders, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

treatment adherence (time frame: two month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02930577, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2016.

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