Impact of Nursing Interventions on Adherence to Treatment With Anti-tuberculosis Drugs in Children and Adolescents

NCT03230409 | Completed DMC

• 1 other identifier: PIC-68-13
• Study Type: interventional
• Target: 359
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tuberculosis

Keywords

Tuberculosis, Latent Tuberculosis Infection, Adherence, Nursing, Pediatrics, Public Health.

Outcome Measures

Primary Outcomes (1)

• Adherence to treatment

  Non-adherence was defined as the presence of any of the following situations: 1. 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. 2. The child failed to attend two or more of the scheduled visits without justification. 3. DOT was indicated for any reason. 4. The child or relatives intentionally stopped the previously prescribed anti-TB treatment. 5. The Eidus-Hamilton urine test was negative on one or more follow-up visits. 6. The written questionnaire showed that compliance was below 80% of the prescribed anti-TB treatment.

  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.

Secondary Outcomes (1)

• Risk Factors

  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.

Study Arms (2)

Phase 1, Retrospective

NO INTERVENTION

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.

Phase 2, Prospective

EXPERIMENTAL

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.

Behavioral: Leaflet written in the patient's/family mother tongue; Behavioral: A follow-up telephone call; Biological: Eidus-Hamilton Test; Behavioral: A written questionnaire

Interventions

Leaflet written in the patient's/family mother tongue BEHAVIORAL

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.

Phase 2, Prospective

A follow-up telephone call BEHAVIORAL

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.

Phase 2, Prospective

Eidus-Hamilton Test BIOLOGICAL

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%

Phase 2, Prospective

A written questionnaire BEHAVIORAL

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).

Phase 2, Prospective

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• In both phases, all children and adolescents (aged \<18 years) starting anti-TB treatment due to close contact with a TB patient (primary chemoprophylaxis), Latent Tuberculosis Infectious (LTBI) or Tuberculosis (TB) disease were eligible to participate in the study.

You may not qualify if:

• Referral from another center after anti-TB treatment had already begun
• 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.

Sponsors & Collaborators

• Hospital Sant Joan de Deu: lead
• Official Barcelona Nurses Association (COIB): collaborator

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 29726024 DERIVED

MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Eva Maria Guix-Comellas, Professor

  Univeristat de Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 26, 2017
• Study Start: January 1, 2014
• Primary Completion: September 30, 2016
• Study Completion: January 15, 2017
• Last Updated: July 26, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: It is always available.
• 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