Behavioural Intervention in Mechanically Ventilated Patients

NCT03932175 | Unknown DMC

• 1 other identifier: NIV - MyPathway
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Noninvasive Ventilation; Chronic Disease Lung

Outcome Measures

Primary Outcomes (1)

• Self efficacy

  Change in the Self Efficacy in Sleep apnea (SEMSA) questionnaire

  3 months

Secondary Outcomes (7)

• mHealth tool usability

  3 months

• Patient satisfaction

  3 months

• Non-invasive ventilation adherence

  3 months

• Patient centred healthcare provision

  3 months

• Continuity of care within the healthcare system

  3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Intervention group

Control group

NO INTERVENTION

Patients will receive usual care according to guidelines on management of chronically ventilated patients, without any mHealth tool or behavioural intervention

Interventions

Intervention group BEHAVIORAL

Behaviorial intervention on non-invasive ventilation use and adherence alongside lifestyle changes recommendations supported by an mHealth tool (MyPathway app)

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (8)

• Lloyd-Owen SJ, Donaldson GC, Ambrosino N, Escarabill J, Farre R, Fauroux B, Robert D, Schoenhofer B, Simonds AK, Wedzicha JA. Patterns of home mechanical ventilation use in Europe: results from the Eurovent survey. Eur Respir J. 2005 Jun;25(6):1025-31. doi: 10.1183/09031936.05.00066704.

  PMID: 15929957 BACKGROUND

• de Lucas Ramos P, Rodriguez Gonzalez-Moro JM, Paz Gonzalez L, Santa-Cruz Siminiani A, Cubillo Marcos JM. [Current status of home mechanical ventilation in Spain: results of a national survey]. Arch Bronconeumol. 2000 Nov;36(10):545-50. Spanish.

  PMID: 11149196 BACKGROUND

• Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.

  PMID: 28489682 BACKGROUND

• Troosters T, Maltais F, Leidy N, Lavoie KL, Sedeno M, Janssens W, Garcia-Aymerich J, Erzen D, De Sousa D, Korducki L, Hamilton A, Bourbeau J. Effect of Bronchodilation, Exercise Training, and Behavior Modification on Symptoms and Physical Activity in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2018 Oct 15;198(8):1021-1032. doi: 10.1164/rccm.201706-1288OC.

  PMID: 29664681 BACKGROUND

• Bandura A. Self-efficacy mechanism in human agency. Am Psychol. 1982;37(2):122-47.

  BACKGROUND

• Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.

  PMID: 847061 BACKGROUND

• Ambrosino N, Vitacca M, Dreher M, Isetta V, Montserrat JM, Tonia T, Turchetti G, Winck JC, Burgos F, Kampelmacher M, Vagheggini G; ERS Tele-Monitoring of Ventilator-Dependent Patients Task Force. Tele-monitoring of ventilator-dependent patients: a European Respiratory Society Statement. Eur Respir J. 2016 Sep;48(3):648-63. doi: 10.1183/13993003.01721-2015. Epub 2016 Jul 7.

  PMID: 27390283 BACKGROUND

• Baltaxe E, Embid C, Aumatell E, Martinez M, Barberan-Garcia A, Kelly J, Eaglesham J, Herranz C, Vargiu E, Montserrat JM, Roca J, Cano I. Integrated Care Intervention Supported by a Mobile Health Tool for Patients Using Noninvasive Ventilation at Home: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Apr 13;8(4):e16395. doi: 10.2196/16395.

  PMID: 32281941 DERIVED

Study Officials

• Cristina Embid, MD

  Hospital Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will assess only anonymized data from the two study groups, wherein every group will also be de-identified in relation to its study arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Two-groups, randomised parallel study with 1:1 ratio

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: April 30, 2019
• Study Start: February 1, 2019
• Primary Completion: June 19, 2019
• Study Completion: June 25, 2019
• Last Updated: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)