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

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BIOLOGICAL

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%

BEHAVIORAL

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).

Sponsors & Collaborators

• Official Barcelona Nurses Association (COIB)

  collaborator UNKNOWN

• Hospital Sant Joan de Deu

  lead OTHER

Principal Investigators

• Eva Maria Guix-Comellas, Professor · Univeristat de Barcelona

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-01

Primary Completion

2016-09-30

Completion

2017-01-15