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van CCT (UK)

van CCT (UK)

Development and testing of an adolescent adherence patient tool for asthma.

- candidate number21688
- NTR NumberNTR5061
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-feb-2015
- Secondary IDs80-83600-98-20002; 14-592/M and NL50997.041.14 ZonMw; METC UMC Utrecht
- Public TitleDevelopment and testing of an adolescent adherence patient tool for asthma.
- Scientific TitleWhy should I use my inhaler? Development and testing of an adolescent adherence patient tool.
- ACRONYMADAPT-asthma study
- hypothesisAn eHealth intervention will be effective in improving adherence and asthma outcomes in adolescents with asthma
- Healt Condition(s) or Problem(s) studiedAsthma, Adolescents, Intervention, Medication adherence, E-health
- Inclusion criteriaAdolescent patients using inhaled corticosteroids (ICS) registered in one of the pharmacies in the UPPER-network.
- Age between 12-18 years
- Use of ICS: filling of ≥ 2 prescriptions for ICS or ICS/LABA combination during the previous 12 months
- Diagnosis of (persistent) asthma (verified by GP)
- Having a smartphone
- Exclusion criteria- Patients who use ICS for indications other than asthma
- Patients who have insufficient understanding of the Dutch language
- Patients who are not able to take care for themselves (e.g. living in an institution)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2015
- planned closingdate1-dec-2016
- Target number of participants360
- InterventionsThe patients in the intervention group receive the ADAPT-intervention, a self-management activating program consisting of a smartphone application for patients combined with a computer management system for healthcare providers (pharmacists). Patients in the control group receive usual care.
Primary and secondary parameters will be measured via questionnaires. Patients and pharmacists in the intervention group receive an additional questionnaire to evaluate the ADAPT intervention.
- Primary outcomeTo evaluate effectiveness of an intervention to improve adherence in adolescents with asthma.
- Secondary outcome- Asthma control
- Asthma-related quality of life
- Medication beliefs
- Illness perceptions
- Patient and pharmacist satisfaction
- Costs effectiveness estimation
- TimepointsPatients in the intervention group use the smartphone application and will be followed by their pharmacist through a management system for 6 months. To determine the effect of the ADAPT intervention a questionnaire is used to measure the primary and secondary parameters at baseline (t=0) and after 6 months at the end of the follow-up (t=6).
- Trial web
- statusinclusion stopped: follow-up
- Sponsor/Initiator Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht Pharmacy Practice Network for Education and Research (UPPER)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Umenz
- PublicationsKosse RC, Bouvy ML, de Vries TW, Kaptein AA, Geers HC, van Dijk L, Koster ES. mHealth intervention to support asthma self-management in adolescents: the ADAPT study. Patient Prefer Adherence 2017;11:571-577.
- Brief summaryNon-adherence to chronic medication is a complex problem and leads to uncontrolled disease, severely effecting quality of life. Little attention has been paid to non-adherence in adolescents and evidence-based interventions to improve medication intake behaviour are lacking for this patient group. The current study evaluates an intervention to improve medication intake behaviour in adolescents with asthma. As adolescents are highly engaged in technology and increasingly communicate through their mobile phone, an adolescent adherence patient tool (ADAPT) intervention consisting of an interactive smartphone application is developed. The ADAPT intervention will be tested in a cluster randomized trial. Adherence is measured through refill records and patients' self-report. In addition, asthma control and asthma-related quality of life are measured via questionnaires. Also a process evaluation will be carried out to assess both patient and healthcare provider satisfaction and invested time. This study might deliver an evidence-based tool to improve adolescent adherence behaviour and contributes to the knowledge about treatment adherence in adolescents. Asthma is used as a model, but insights from this study will also be valuable for future interventions aiming at adolescents suffering other chronic disorders.
- Main changes (audit trail)
- RECORD17-feb-2015 - 1-okt-2017

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