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

July 25, 2017 updated by: Hospital Sant Joan de Deu

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

359

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to treatment
Time Frame: 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.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk Factors
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sant Joan de Deu

Collaborators

Official Barcelona Nurses Association (COIB)

Investigators

  • Principal Investigator: Eva Maria Guix-Comellas, Professor, Univeristat de Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

September 30, 2016

Study Completion (Actual)

January 15, 2017

Study Registration Dates

First Submitted

July 21, 2017

First Submitted That Met QC Criteria

July 25, 2017

First Posted (Actual)

July 26, 2017

Study Record Updates

Last Update Posted (Actual)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIC-68-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The Study Protocol has been published in Journal of Advanced Nursing

IPD Sharing Time Frame

It is always available.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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