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Behavioural Intervention in Mechanically Ventilated Patients

26 aprile 2019 aggiornato da: CRISTINA EMBID LOPEZ, Hospital Clinic of Barcelona

Effects of a Behavioural Intervention in Home-based Mechanically Ventilated Patients

Background: Non-invasive ventilation at home for chronic respiratory failure due to different etiologies has proven effective regarding mortality and quality of life. Nonetheless, adherence to therapy still constitutes a clinical day-to-day problem. Physiological monitoring has shown to improve adherence. We hypothesise that an additional behavioural intervention delivered via mHealth tools, on top of usual care, can further enhance therapeutical success alongside patient satisfaction.

Methods: Randomized single-blinded controlled trial with an intervention and control groups. Intervention will consist of a multi-component based behavioural intervention delivered via a mHealth tool, during a three-month period. Primary objective will be change in self-efficacy towards non-invasive ventilation use

Statistical Analysis: Based on a change of 0.5 units in the Self Efficacy in Sleep apnea (SEMSA) questionnaire, a sample size of 30 subjects per study arm was calculated. It has been anticipated a drop-out rate of 5%. Standard statistical analysis will take place.

Expected results: we expect a positive change on the SEMSA score (reflecting better self-efficacy) after three-month use. Indirectly, this enhancement should facilitate patient adherence specifically via mask leak problems resolution. Also, we presume that the proposed mHealth tool will be highly usable and accepted by the patients, leading to overall satisfaction with the service provided.

Panoramica dello studio

Stato

Sconosciuto

Intervento / Trattamento

Descrizione dettagliata

The polio epidemics demonstrated the safety and efficacy of non-invasive ventilation (NIV) to decrease mortality. Since then, this therapeutic approach has been shown to reduce hospital admissions, impact favourably on health-related quality of life (HRQL), improve sleep quality and reduce mortality in patients with diverse chronic pathologies. This success has driven the increase in prevalence of patients using home NIV in Europe, ranging from 4.5 to 20 per 100,000 adults.

The use of NIV at home has been proven to be cost-effective, but patients' adherence to therapy has still potential to improve which should further enhance healthcare efficiencies of the intervention. Optimization of physiological settings and monitoring can contribute to enhance adherence by improving timely detection of problems such as mask leaks, patient-ventilator asynchronies, etc. However, improvement of behavioural aspects such as patient motivation and empowerment for self-management are also important factors to consider when addressing adherence to respiratory therapies.

The current protocol seeks to explore the transfer of previous positive experiences on behavioural interventions in other fields (i.e. physical activity into home-based NIV and, in general, into respiratory therapies. Specifically, we will explore the concept of self-efficacy. It is defined as the individual's perceived capability to perform the particular behaviour. A person who does not believe in her or his own capability to perform a desired action will fail to adopt, initiate, and maintain it. Self-efficacy is therefore seen as the most influential motivational factor and the strongest predictor of behavioural intentions.

The application of self-efficacy to the problem of identifying predictors of BIPAP use derives from the social cognitive theory concept of Bandura (Bandura's model). This model has been widely applied in studies of the adoption, initiation, and maintenance of health-promoting behaviors and consists of the concepts of perception of the risk to health, expectations regarding treatment outcome (outcome expectancies), and the confidence or volition to engage in the behavior (treatment self-efficacy).

Alongside this well-defined behavioural concept, we also identify the role of information and communication technologies (ICT) as a promising scenario to generate efficiencies by enhancing coordination between stakeholders and contributing to improve health outcomes.

Nonetheless, it is acknowledged that the scenario is not still mature. Mainly, because of lacking evidence in real-world scenarios for the capacity of ICT to escort behavioural changes in chronic complex patients. It is widely accepted that, despite current limitations, chronic complex patients are an ideal population where care coordination, patient and medical staff satisfaction alongside patient empowerment are of utmost importance to produce health benefits.

The study protocol intends to produce evidence on the capacity of a behavioural intervention to increase patient empowerment for self-management and adherence to therapy accompanied by an ICT tool interoperable with the information system of the healthcare provider. Moreover, the intervention should generate high acceptability/satisfaction among patients, carers and professionals. We fully acknowledge that if the expected results are achieved, the proposed study shall be followed by long-term assessment of the impact of the intervention.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

67

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Catalonia
      • Barcelona, Catalonia, Spagna, 08036
        • Hospital Clínic

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • All adult patients with hypercapnic ventilatory failure due to chest wall, neuromuscular, lung parenchyma and/ or airway disease already receiving treatment with non-invasive ventilation irrespective of treatment duration.
  • Having a mobile phone, tablet or personal computer that can support the use of MyPathway application.
  • Accepting to participate in the study and signing informed consent.

Exclusion Criteria:

  • Clinical instability (including a respiratory acute exacerbation) at time of assessment for study enrolment.
  • Not willing to use the proposed mHealth tool at home.
  • Severe psychiatric disease.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention group
The multicomponent intervention will comprise three aspects on-top of usual care: i) Motivational interview to assess patient's adherence profile and to raise the compromise with the behaviour change towards NIV, physical activity and nutritional habits; ii) Bi-directional interaction between the study participants and clinical staff delivered by the MyPathway app, where specific clinical problems regarding NIV will be addressed as they arise; and iii) Motivational messages and educational material delivered via the MyPathway app regarding changes in physical activity and/or nutritional habits. As part of the behavioural intervention, goal setting for NIV adherence and life-style changes will be introduced to the MyPathway app in order for the participants to follow the advice.
Behaviorial intervention on non-invasive ventilation use and adherence alongside lifestyle changes recommendations supported by an mHealth tool (MyPathway app)
Nessun intervento: Control group
Patients will receive usual care according to guidelines on management of chronically ventilated patients, without any mHealth tool or behavioural intervention

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Self efficacy
Lasso di tempo: 3 months
Change in the Self Efficacy in Sleep apnea (SEMSA) questionnaire
3 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
mHealth tool usability
Lasso di tempo: 3 months
mHealth tool usability assessed by the System Usability Scale
3 months
Patient satisfaction
Lasso di tempo: 3 months
Patient satisfaction with the mHealth tool assessed by the Net Promoter Score
3 months
Non-invasive ventilation adherence
Lasso di tempo: 3 months
Number of hours of daily use of the non-invasive ventilation machine during the study period
3 months
Patient centred healthcare provision
Lasso di tempo: 3 months
Patient centred healthcare provision as measured by the Person Centred Coordinated Experience Questionnaire
3 months
Continuity of care within the healthcare system
Lasso di tempo: 3 months
Continuity of care within the healthcare system as measured by the Nijmegen Continuity of Care Questionnaire
3 months
Health and well-being
Lasso di tempo: 3 months
Change in quality of life assessed by the EuroQol-5D questionnaire
3 months
Sleepiness
Lasso di tempo: 3 months
Change in sleepiness assessed by the Epworth Sleepiness Score
3 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Cristina Embid, MD, Hospital Clínic

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 febbraio 2019

Completamento primario (Anticipato)

19 giugno 2019

Completamento dello studio (Anticipato)

25 giugno 2019

Date di iscrizione allo studio

Primo inviato

26 aprile 2019

Primo inviato che soddisfa i criteri di controllo qualità

26 aprile 2019

Primo Inserito (Effettivo)

30 aprile 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 aprile 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 aprile 2019

Ultimo verificato

1 aprile 2019

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • NIV - MyPathway

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Intervention group

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