<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03230409</url>
  </required_header>
  <id_info>
    <org_study_id>PIC-68-13</org_study_id>
    <nct_id>NCT03230409</nct_id>
  </id_info>
  <brief_title>Impact of Nursing Interventions on Adherence to Treatment With Anti-tuberculosis Drugs in Children and Adolescents</brief_title>
  <official_title>Impact of Nursing Interventions on Adherence to Treatment With Anti-tuberculosis Drugs in Children and Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Sant Joan de Deu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Official Barcelona Nurses Association (COIB)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Sant Joan de Deu</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the efficacy of nursing interventions on adherence to antituberculosis&#xD;
      medication in a paediatric cohort (aged 0-18 years) and identifies the risk factors for&#xD;
      non-compliance.&#xD;
&#xD;
      There are two phases in the study; Phase 1: retrospective descriptive analysis in children&#xD;
      and young people receiving antituberculosis treatment (non-intervention group); and Phase 2:&#xD;
      quasi-experimental, longitudinal, prospective study (intervention group). The results of the&#xD;
      two phases will be compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was carried out in the outpatient tuberculosis (TB) Unit of a tertiary-care&#xD;
      pediatric center in Catalonia (Northeast Spain), which is a referral center for pediatric TB&#xD;
      (Hospital Sant Joan de Déu) in the Southern Barcelona Health Care Region (Regió Sanitària&#xD;
      Barcelona Sud) (1,346,000 inhabitants, 16.5% of whom are under 18 years of age).The TB&#xD;
      incidence rate in Catalonia has decreased from 21.6 per 100,000 population in 2004 to 14.4 in&#xD;
      2015 (7.3 cases per 100,000 population of pediatric age)(Rodés, Espinilla, &amp; García, 2016).&#xD;
&#xD;
      In both phases, all children and adolescents (aged &lt;18 years) starting anti-tuberculosis&#xD;
      (anti-TB) treatment due to close contact with a TB patient (primary chemoprophylaxis), Latent&#xD;
      Tuberculosis Infection (LTBI) or TB disease were eligible to participate in the study.&#xD;
      Directly Observed Treatment (DOT) is not routinely available in Spain, and its use is&#xD;
      restricted to individual cases, as per physician decision.&#xD;
&#xD;
      The number of children and adolescents required to participate in the study was calculated&#xD;
      using a unilateral chi-square proportion comparison test for independent samples, with a&#xD;
      level of significance of 5% and a power of 80%, a 2/1 ratio in Phase 1/Phase 2 group sizes&#xD;
      and assuming a significant increase of 15% in the adherence rate after the nurse-led&#xD;
      interventions (60% in Phase 1 and 75% in Phase 2). Thus, it was calculated that 182 and 91&#xD;
      children and adolescents would be needed in the Phase 1 and Phase 2 groups, respectively.&#xD;
&#xD;
      Procedure and interventions:&#xD;
&#xD;
      As per national guidelines, primary chemoprophylaxis after TB contact consists of isoniazid&#xD;
      in monotherapy until TB infection screening is repeated 10-12 weeks later. Treatment of LTBI&#xD;
      includes either 3 months of isoniazid and rifampicin or 6-9 months of isoniazid in&#xD;
      monotherapy, and treatment of TB disease consists of a 2-month induction phase with 4 drugs&#xD;
      (isoniazid, rifampicin, pyrazinamide and ethambutol), followed by isoniazid and rifampicin&#xD;
      for a minimum of 4 months.&#xD;
&#xD;
      Routine outpatient follow-up visits were scheduled as follows: (a) in patients receiving&#xD;
      primary chemoprophylaxis or LTBI treatment: baseline visit, and 2 weeks and 3 months later&#xD;
      (end of treatment in most cases); (b) in patients treated for TB disease: baseline visit, 2&#xD;
      weeks later and on a monthly basis thereafter.&#xD;
&#xD;
      Four nurse-led interventions were implemented after Phase 1: 2 educational interventions&#xD;
      (leaflet in mother tongue and a follow-up open telephone call) and 2 monitoring interventions&#xD;
      (the Eidus-Hamilton test and a written questionnaire about adherence to anti-TB treatment),&#xD;
      which were exclusively carried out by 2 study nurses.&#xD;
&#xD;
      Whenever the Eidus-Hamilton test or the written questionnaire were consistent with&#xD;
      sub-optimal adherence, immediate feedback was given to the parents and the patient the study&#xD;
      nurse underlined the importance of adherence, assessed any potential hindrances and answered&#xD;
      any questions. A follow-up visit or telephone call was scheduled 7-10 days later.&#xD;
&#xD;
      The level of adherence to anti-TB treatment was be identified retrospectively in Phase 1 of&#xD;
      the study, as the risk factors associated with adherence in our cohort. Once Phase 2 was&#xD;
      completed, the results were be compared with those of Phase 1 and the success of the new&#xD;
      nurse-led interventions assessed.&#xD;
&#xD;
      Final results will be used to design the definitive Nurse-led Follow-up Programme that will&#xD;
      be implemented in the TB Unit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 1, 2014</start_date>
  <completion_date type="Actual">January 15, 2017</completion_date>
  <primary_completion_date type="Actual">September 30, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to treatment</measure>
    <time_frame>Through the study completion, an average of 3 months for those patients starting anti-TB treatment due to close contact with a TB patient (primary chemoprophylaxis) or LTBI and 6-9 months for those with TB disease.</time_frame>
    <description>Non-adherence was defined as the presence of any of the following situations:&#xD;
At the follow-up visits, it was calculated and/or the children or relatives stated that they had failed to take &gt;20% of the previously prescribed anti-TB treatment.&#xD;
The child failed to attend two or more of the scheduled visits without justification.&#xD;
DOT was indicated for any reason.&#xD;
The child or relatives intentionally stopped the previously prescribed anti-TB treatment.&#xD;
The Eidus-Hamilton urine test was negative on one or more follow-up visits.&#xD;
The written questionnaire showed that compliance was below 80% of the prescribed anti-TB treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk Factors</measure>
    <time_frame>Through the study completion, an average of 3 months for those patients starting anti-TB treatment due to close contact with a TB patient (primary chemoprophylaxis) or LTBI and 6-9 months for those with TB disease.</time_frame>
    <description>To identify epidemiological, clinical or social markers that make it possible to predict good or poor adherence to anti-TB treatment in children and young people.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">359</enrollment>
  <condition>Tuberculosis</condition>
  <arm_group>
    <arm_group_label>Phase 1, Retrospective</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Routine outpatient follow-up visits were scheduled as follows: (a) in patients receiving primary chemoprophylaxis or Latent Tuberculosis Infection (LTBI) treatment: baseline visit, and 2 weeks and 3 months later (end of treatment in most cases); (b) in patients treated for Tuberculosis disease: baseline visit, 2 weeks later and on a monthly basis thereafter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2, Prospective</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four nurse-led interventions were implemented after Phase 1:&#xD;
Intervention 1: at baseline visit, the parents or carers of the children, were given a leaflet in the mother tongue. This leaflet was available in 10 different languages: Spanish and Catalan (the two official languages of the country), English, French, German, Russian, Romanian, Chinese, Urdu and Arabic.&#xD;
Intervention 2: a follow-up open telephone call was made 7-10 days after the baseline visit and whenever the patient failed to attend the scheduled visits.&#xD;
Intervention 3: the Eidus-Hamilton test was performed twice, 2 weeks after the baseline visit and at the end of treatment. To prevent patients from only taking their medication occasionally, directly before their visits, they were not informed of the purpose of the urine test.&#xD;
Intervention 4: a written questionnaire about adherence to anti-TB treatment on all the follow-up visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Leaflet written in the patient's/family mother tongue</intervention_name>
    <description>At baseline visit, the parents or carers of the children and/or the young patients themselves (in the case of adolescents &gt;12 years of age), were given a leaflet including questions and answers about the most common doubts that people have about anti-TB treatment (what to do if you forget a dose, if you vomit, if you have stomach ache, etc.). The study nurse read and reviewed the leaflet with the family. This leaflet was available in 10 different languages: Spanish and Catalan (the two official languages of the country), English, French, German, Russian, Romanian, Chinese, Urdu and Arabic.</description>
    <arm_group_label>Phase 2, Prospective</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A follow-up telephone call</intervention_name>
    <description>A follow-up open telephone call was made 7-10 days after the baseline visit and whenever the patient failed to attend the scheduled visits. The parents and/or patient were informed about this. This call was made to reinforce the information, answer any questions that may have arisen and insist on the importance of proper follow-up.</description>
    <arm_group_label>Phase 2, Prospective</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Eidus-Hamilton Test</intervention_name>
    <description>E-H test was performed twice, 2 weeks after the baseline visit and at the end of treatment. To prevent patients from only taking their medication occasionally, directly before their visits, they were not informed of the purpose of the urine test. This test is a rapid, simple point-of-care method to detect urinary acetyl-isoniazid, the main metabolite of isoniazid, up to 12-24 hours following isoniazid administration and is used as a surrogate marker of treatment adherence. The test consists of placing 4 drops of a 10%potassium cyanide solution and 9 drops of a 10%chloramine solution in a test tube containing 4 drops of patient urine. The result is considered positive if a deep red color develops after 1 minute. If a pink color slowly appears,this indicates that there are only traces of the metabolite. If there is no change in color, the result is considered negative and suggests no recent isoniazid intake. The sensitivity and specificity of this test have been reported to be over 99%</description>
    <arm_group_label>Phase 2, Prospective</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A written questionnaire</intervention_name>
    <description>The parents or carers of the children and/or the young patients themselves were asked to complete a written questionnaire about adherence to anti-TB treatment on all the follow-up visits, which was partially adapted from two validated questionnaires on adherence to chronic therapies (SMAQ compliance test, Svarstad et al., 1999; and Hermes test, Rodríguez-Chamorro et al., 2008).</description>
    <arm_group_label>Phase 2, Prospective</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In both phases, all children and adolescents (aged &lt;18 years) starting anti-TB&#xD;
             treatment due to close contact with a TB patient (primary chemoprophylaxis), Latent&#xD;
             Tuberculosis Infectious (LTBI) or Tuberculosis (TB) disease were eligible to&#xD;
             participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Referral from another center after anti-TB treatment had already begun&#xD;
&#xD;
          -  Patients with other chronic diseases requiring hospital follow-up and/or other chronic&#xD;
             therapies&#xD;
&#xD;
          -  Known poor previous adherence to anti-TB treatment (if treatment was repeated or&#xD;
             restarted)&#xD;
&#xD;
          -  A significant language barrier that prevented the child or his/her relatives from&#xD;
             properly understanding the nature of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eva Maria Guix-Comellas, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univeristat de Barcelona</affiliation>
  </overall_official>
  <reference>
    <citation>Amlabu V, Mulligan C, Jele N, Evans A, Gray D, Zar HJ, McIlleron H, Smith P. Isoniazid/acetylisoniazid urine concentrations: markers of adherence to isoniazid preventive therapy in children. Int J Tuberc Lung Dis. 2014 May;18(5):528-30. doi: 10.5588/ijtld.13.0730.</citation>
    <PMID>24903787</PMID>
  </reference>
  <reference>
    <citation>Cass AD, Talavera GA, Gresham LS, Moser KS, Joy W. Structured behavioral intervention to increase children's adherence to treatment for latent tuberculosis infection. Int J Tuberc Lung Dis. 2005 Apr;9(4):415-20.</citation>
    <PMID>15830747</PMID>
  </reference>
  <reference>
    <citation>Chang SH, Eitzman SR, Nahid P, Finelli ML. Factors associated with failure to complete isoniazid therapy for latent tuberculosis infection in children and adolescents. J Infect Public Health. 2014 Mar-Apr;7(2):145-52. doi: 10.1016/j.jiph.2013.11.001. Epub 2013 Dec 19.</citation>
    <PMID>24361084</PMID>
  </reference>
  <reference>
    <citation>Cruz AT, Starke JR. Increasing adherence for latent tuberculosis infection therapy with health department-administered therapy. Pediatr Infect Dis J. 2012 Feb;31(2):193-5. doi: 10.1097/INF.0b013e318236984f.</citation>
    <PMID>21979799</PMID>
  </reference>
  <reference>
    <citation>Garfield S, Clifford S, Eliasson L, Barber N, Willson A. Suitability of measures of self-reported medication adherence for routine clinical use: a systematic review. BMC Med Res Methodol. 2011 Nov 3;11:149. doi: 10.1186/1471-2288-11-149.</citation>
    <PMID>22050830</PMID>
  </reference>
  <reference>
    <citation>Guix-Comellas EM, Rozas L, Velasco-Arnaiz E, Morin-Fraile V, Force-Sanmartin E, Noguera-Julian A. Adherence to Antituberculosis Drugs in Children and Adolescents in A Low-Endemic Setting: A Retrospective Series. Pediatr Infect Dis J. 2017 Jun;36(6):616-618. doi: 10.1097/INF.0000000000001508.</citation>
    <PMID>28030525</PMID>
  </reference>
  <reference>
    <citation>M'imunya JM, Kredo T, Volmink J. Patient education and counselling for promoting adherence to treatment for tuberculosis. Cochrane Database Syst Rev. 2012 May 16;2012(5):CD006591. doi: 10.1002/14651858.CD006591.pub2.</citation>
    <PMID>22592714</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tuberculosis, Latent Tuberculosis Infection, Adherence, Nursing, Pediatrics, Public Health.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Study Protocol has been published in Journal of Advanced Nursing</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>It is always available.</ipd_time_frame>
    <ipd_access_criteria>Guix-Comellas, E. M., Rozas-Quesada, L., Force-Sanmartín, E., Estrada-Masllorens, J. M., Galimany-Masclans, J., &amp; Noguera-Julian, A. (2015). Influence of nursing interventions on adherence to treatment with antituberculosis drugs in children and young people: research protocol. Journal of Advanced Nursing, 71(9), 2189-99. http://doi.org/10.1111/jan.12656</ipd_access_criteria>
    <ipd_url>http://doi.org/10.1111/jan.12656</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03230409
org study id: PIC-68-13
nct id: NCT03230409
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the efficacy of nursing interventions on adherence to antituberculosis
      medication in a paediatric cohort (aged 0-18 years) and identifies the risk factors for
      non-compliance.

      There are two phases in the study; Phase 1: retrospective descriptive analysis in children
      and young people receiving antituberculosis treatment (non-intervention group); and Phase 2:
      quasi-experimental, longitudinal, prospective study (intervention group). The results of the
      two phases will be compared.
The study was carried out in the outpatient tuberculosis (TB) Unit of a tertiary-care
      pediatric center in Catalonia (Northeast Spain), which is a referral center for pediatric TB
      (Hospital Sant Joan de Déu) in the Southern Barcelona Health Care Region (Regió Sanitària
      Barcelona Sud) (1,346,000 inhabitants, 16.5% of whom are under 18 years of age).The TB
      incidence rate in Catalonia has decreased from 21.6 per 100,000 population in 2004 to 14.4 in
      2015 (7.3 cases per 100,000 population of pediatric age)(Rodés, Espinilla, & García, 2016).

      In both phases, all children and adolescents (aged <18 years) starting anti-tuberculosis
      (anti-TB) treatment due to close contact with a TB patient (primary chemoprophylaxis), Latent
      Tuberculosis Infection (LTBI) or TB disease were eligible to participate in the study.
      Directly Observed Treatment (DOT) is not routinely available in Spain, and its use is
      restricted to individual cases, as per physician decision.

      The number of children and adolescents required to participate in the study was calculated
      using a unilateral chi-square proportion comparison test for independent samples, with a
      level of significance of 5% and a power of 80%, a 2/1 ratio in Phase 1/Phase 2 group sizes
      and assuming a significant increase of 15% in the adherence rate after the nurse-led
      interventions (60% in Phase 1 and 75% in Phase 2). Thus, it was calculated that 182 and 91
      children and adolescents would be needed in the Phase 1 and Phase 2 groups, respectively.

      Procedure and interventions:

      As per national guidelines, primary chemoprophylaxis after TB contact consists of isoniazid
      in monotherapy until TB infection screening is repeated 10-12 weeks later. Treatment of LTBI
      includes either 3 months of isoniazid and rifampicin or 6-9 months of isoniazid in
      monotherapy, and treatment of TB disease consists of a 2-month induction phase with 4 drugs
      (isoniazid, rifampicin, pyrazinamide and ethambutol), followed by isoniazid and rifampicin
      for a minimum of 4 months.

      Routine outpatient follow-up visits were scheduled as follows: (a) in patients receiving
      primary chemoprophylaxis or LTBI treatment: baseline visit, and 2 weeks and 3 months later
      (end of treatment in most cases); (b) in patients treated for TB disease: baseline visit, 2
      weeks later and on a monthly basis thereafter.

      Four nurse-led interventions were implemented after Phase 1: 2 educational interventions
      (leaflet in mother tongue and a follow-up open telephone call) and 2 monitoring interventions
      (the Eidus-Hamilton test and a written questionnaire about adherence to anti-TB treatment),
      which were exclusively carried out by 2 study nurses.

      Whenever the Eidus-Hamilton test or the written questionnaire were consistent with
      sub-optimal adherence, immediate feedback was given to the parents and the patient the study
      nurse underlined the importance of adherence, assessed any potential hindrances and answered
      any questions. A follow-up visit or telephone call was scheduled 7-10 days later.

      The level of adherence to anti-TB treatment was be identified retrospectively in Phase 1 of
      the study, as the risk factors associated with adherence in our cohort. Once Phase 2 was
      completed, the results were be compared with those of Phase 1 and the success of the new
      nurse-led interventions assessed.

      Final results will be used to design the definitive Nurse-led Follow-up Programme that will
      be implemented in the TB Unit.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Adherence to treatment
time frame: Through the study completion, an average of 3 months for those patients starting anti-TB treatment due to close contact with a TB patient (primary chemoprophylaxis) or LTBI and 6-9 months for those with TB disease.
description: Non-adherence was defined as the presence of any of the following situations:
At the follow-up visits, it was calculated and/or the children or relatives stated that they had failed to take >20% of the previously prescribed anti-TB treatment.
The child failed to attend two or more of the scheduled visits without justification.
DOT was indicated for any reason.
The child or relatives intentionally stopped the previously prescribed anti-TB treatment.
The Eidus-Hamilton urine test was negative on one or more follow-up visits.
The written questionnaire showed that compliance was below 80% of the prescribed anti-TB treatment.
measure: Risk Factors
time frame: Through the study completion, an average of 3 months for those patients starting anti-TB treatment due to close contact with a TB patient (primary chemoprophylaxis) or LTBI and 6-9 months for those with TB disease.
description: To identify epidemiological, clinical or social markers that make it possible to predict good or poor adherence to anti-TB treatment in children and young people.
arm group label: Phase 1, Retrospective
arm group type: No Intervention
description: Routine outpatient follow-up visits were scheduled as follows: (a) in patients receiving primary chemoprophylaxis or Latent Tuberculosis Infection (LTBI) treatment: baseline visit, and 2 weeks and 3 months later (end of treatment in most cases); (b) in patients treated for Tuberculosis disease: baseline visit, 2 weeks later and on a monthly basis thereafter.
arm group label: Phase 2, Prospective
arm group type: Experimental
description: Four nurse-led interventions were implemented after Phase 1:
Intervention 1: at baseline visit, the parents or carers of the children, were given a leaflet in the mother tongue. This leaflet was available in 10 different languages: Spanish and Catalan (the two official languages of the country), English, French, German, Russian, Romanian, Chinese, Urdu and Arabic.
Intervention 2: a follow-up open telephone call was made 7-10 days after the baseline visit and whenever the patient failed to attend the scheduled visits.
Intervention 3: the Eidus-Hamilton test was performed twice, 2 weeks after the baseline visit and at the end of treatment. To prevent patients from only taking their medication occasionally, directly before their visits, they were not informed of the purpose of the urine test.
Intervention 4: a written questionnaire about adherence to anti-TB treatment on all the follow-up visits.
intervention type: Behavioral
intervention name: Leaflet written in the patient's/family mother tongue
description: At baseline visit, the parents or carers of the children and/or the young patients themselves (in the case of adolescents >12 years of age), were given a leaflet including questions and answers about the most common doubts that people have about anti-TB treatment (what to do if you forget a dose, if you vomit, if you have stomach ache, etc.). The study nurse read and reviewed the leaflet with the family. This leaflet was available in 10 different languages: Spanish and Catalan (the two official languages of the country), English, French, German, Russian, Romanian, Chinese, Urdu and Arabic.
arm group label: Phase 2, Prospective
intervention type: Behavioral
intervention name: A follow-up telephone call
description: A follow-up open telephone call was made 7-10 days after the baseline visit and whenever the patient failed to attend the scheduled visits. The parents and/or patient were informed about this. This call was made to reinforce the information, answer any questions that may have arisen and insist on the importance of proper follow-up.
arm group label: Phase 2, Prospective
intervention type: Biological
intervention name: Eidus-Hamilton Test
description: E-H test was performed twice, 2 weeks after the baseline visit and at the end of treatment. To prevent patients from only taking their medication occasionally, directly before their visits, they were not informed of the purpose of the urine test. This test is a rapid, simple point-of-care method to detect urinary acetyl-isoniazid, the main metabolite of isoniazid, up to 12-24 hours following isoniazid administration and is used as a surrogate marker of treatment adherence. The test consists of placing 4 drops of a 10%potassium cyanide solution and 9 drops of a 10%chloramine solution in a test tube containing 4 drops of patient urine. The result is considered positive if a deep red color develops after 1 minute. If a pink color slowly appears,this indicates that there are only traces of the metabolite. If there is no change in color, the result is considered negative and suggests no recent isoniazid intake. The sensitivity and specificity of this test have been reported to be over 99%
arm group label: Phase 2, Prospective
intervention type: Behavioral
intervention name: A written questionnaire
description: The parents or carers of the children and/or the young patients themselves were asked to complete a written questionnaire about adherence to anti-TB treatment on all the follow-up visits, which was partially adapted from two validated questionnaires on adherence to chronic therapies (SMAQ compliance test, Svarstad et al., 1999; and Hermes test, Rodríguez-Chamorro et al., 2008).
arm group label: Phase 2, Prospective
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Eva Maria Guix-Comellas, Professor
role: Principal Investigator
affiliation: Univeristat de Barcelona
citation: Amlabu V, Mulligan C, Jele N, Evans A, Gray D, Zar HJ, McIlleron H, Smith P. Isoniazid/acetylisoniazid urine concentrations: markers of adherence to isoniazid preventive therapy in children. Int J Tuberc Lung Dis. 2014 May;18(5):528-30. doi: 10.5588/ijtld.13.0730.
PMID: 24903787
citation: Cass AD, Talavera GA, Gresham LS, Moser KS, Joy W. Structured behavioral intervention to increase children's adherence to treatment for latent tuberculosis infection. Int J Tuberc Lung Dis. 2005 Apr;9(4):415-20.
PMID: 15830747
citation: Chang SH, Eitzman SR, Nahid P, Finelli ML. Factors associated with failure to complete isoniazid therapy for latent tuberculosis infection in children and adolescents. J Infect Public Health. 2014 Mar-Apr;7(2):145-52. doi: 10.1016/j.jiph.2013.11.001. Epub 2013 Dec 19.
PMID: 24361084
citation: Cruz AT, Starke JR. Increasing adherence for latent tuberculosis infection therapy with health department-administered therapy. Pediatr Infect Dis J. 2012 Feb;31(2):193-5. doi: 10.1097/INF.0b013e318236984f.
PMID: 21979799
citation: Garfield S, Clifford S, Eliasson L, Barber N, Willson A. Suitability of measures of self-reported medication adherence for routine clinical use: a systematic review. BMC Med Res Methodol. 2011 Nov 3;11:149. doi: 10.1186/1471-2288-11-149.
PMID: 22050830
citation: Guix-Comellas EM, Rozas L, Velasco-Arnaiz E, Morin-Fraile V, Force-Sanmartin E, Noguera-Julian A. Adherence to Antituberculosis Drugs in Children and Adolescents in A Low-Endemic Setting: A Retrospective Series. Pediatr Infect Dis J. 2017 Jun;36(6):616-618. doi: 10.1097/INF.0000000000001508.
PMID: 28030525
citation: M'imunya JM, Kredo T, Volmink J. Patient education and counselling for promoting adherence to treatment for tuberculosis. Cochrane Database Syst Rev. 2012 May 16;2012(5):CD006591. doi: 10.1002/14651858.CD006591.pub2.
PMID: 22592714
responsible party type: Sponsor
mesh term: Tuberculosis
sharing ipd: Yes
ipd description: The Study Protocol has been published in Journal of Advanced Nursing
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: It is always available.
ipd access criteria: Guix-Comellas, E. M., Rozas-Quesada, L., Force-Sanmartín, E., Estrada-Masllorens, J. M., Galimany-Masclans, J., & Noguera-Julian, A. (2015). Influence of nursing interventions on adherence to treatment with antituberculosis drugs in children and young people: research protocol. Journal of Advanced Nursing, 71(9), 2189-99. http://doi.org/10.1111/jan.12656
ipd url: http://doi.org/10.1111/jan.12656