Tuberculosis Clinical Trial
Official title:
Impact of Nursing Interventions on Adherence to Treatment With Anti-tuberculosis Drugs in Children and Adolescents
Verified date | July 2017 |
Source | Hospital Sant Joan de Deu |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 359 |
Est. completion date | January 15, 2017 |
Est. primary completion date | September 30, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospital Sant Joan de Deu | Official Barcelona Nurses Association (COIB) |
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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation
Guix-Comellas EM, Rozas L, Velasco-Arnaiz E, Morín-Fraile V, Force-Sanmartín 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. — View 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;(5):CD006591. doi: 10.1002/14651858.CD006591.pub2. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence to treatment | 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. |
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 | Risk Factors | 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. | 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. |
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