Impact of Nursing Interventions on Adherence to Treatment With Anti-tuberculosis Drugs in Children and Adolescents
NCT ID: NCT03230409
Last Updated: 2017-07-26
Study Results
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Basic Information
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COMPLETED
NA
359 participants
INTERVENTIONAL
2014-01-01
2017-01-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Phase 1, Retrospective
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.
No interventions assigned to this group
Phase 2, Prospective
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.
Leaflet written in the patient's/family mother tongue
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.
A follow-up telephone call
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.
Eidus-Hamilton Test
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%
A written questionnaire
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).
Interventions
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Leaflet written in the patient's/family mother tongue
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.
A follow-up telephone call
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.
Eidus-Hamilton Test
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%
A written questionnaire
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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with other chronic diseases requiring hospital follow-up and/or other chronic therapies
* Known poor previous adherence to anti-TB treatment (if treatment was repeated or restarted)
* A significant language barrier that prevented the child or his/her relatives from properly understanding the nature of the study.
18 Years
ALL
No
Sponsors
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Official Barcelona Nurses Association (COIB)
UNKNOWN
Hospital Sant Joan de Deu
OTHER
Responsible Party
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Principal Investigators
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Eva Maria Guix-Comellas, Professor
Role: PRINCIPAL_INVESTIGATOR
Univeristat de Barcelona
References
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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.
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.
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.
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.
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.
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.
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.
Guix-Comellas EM, Rozas-Quesada L, Velasco-Arnaiz E, Ferres-Canals A, Estrada-Masllorens JM, Force-Sanmartin E, Noguera-Julian A. Impact of nursing interventions on adherence to treatment with antituberculosis drugs in children and young people: A nonrandomized controlled trial. J Adv Nurs. 2018 May 3. doi: 10.1111/jan.13692. Online ahead of print.
Other Identifiers
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PIC-68-13
Identifier Type: -
Identifier Source: org_study_id
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