Tuberculosis Clinical Trial
Official title:
Impact of Nursing Interventions on Adherence to Treatment With Anti-tuberculosis Drugs in Children and Adolescents
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.
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