Clinical trial NCT06116292: Impact of the Implementation of a Telemedicine Program on Patients Diagnosed with Asthma
Official title: Impact of the Implementation of a Telemedicine Program on Patients Diagnosed with Asthma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Telemedicine
Adherence, Treatment
Quality of Life
Control
Keywords: Asthma
Telemedicine
Asthma Control
Quality of Live
Adherence, Treatment
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Asthma is one of the most common chronic respiratory diseases worldwide. Despite the extensive knowledge of the condition and available therapeutic options, severe asthmatic patients have poor disease control in 50% of cases.

Objective: To assess the impact of implementing a mobile application (ESTOI) in patients diagnosed with asthma on disease control, treatment adherence, and perceived quality of life.

Methodology: A 52-week randomized clinical trial involving asthma patients receiving care at a highly specialized hospital in Spain. A total of 108 patients will be included and divided into two groups. The intervention group will receive more comprehensive monitoring than usual, including access to the ESTOI application. The Asthma Control Test (ACT) questionnaire will be used as the primary assessment variable. Other variables to be studied include the Inhaler Adherence Test (TAI), the number of exacerbations, peak expiratory flow, exhaled nitric oxide examination, hospital anxiety and depression scale, asthma quality of life questionnaire, forced spirometry parameters (FVC, FEV1, and reversibility), and analytical parameters (eosinophilia and IgE).

Detailed description: Design: A 52-week randomized clinical trial will be conducted, using a single-blind approach, in patients with asthma. There will be two study arms: the control cohort will receive standard care, while the intervention group will also have access to the mobile application (ESTOI).

Setting and Subjects: The study will take place in the pulmonology department of Bellvitge University Hospital in Barcelona, during the years 2024-2026.

Procedure and Instruments: The project will be structured into three visits. During the first visit, all participants will be seen by the pulmonologist at our center for asthma classification, inhaler updates, and requests for additional tests. Subsequently, the control group will receive health education (provided by the asthma specialist nurse) regarding their condition, treatment plan, signs of alarm, action plan, and a review of asthma triggers. On the other hand, intervention group patients, in addition to health education, will be introduced to the ESTOI application database and provided access to the patient portal, where patients will find all the necessary information on asthma management. Both groups will receive a Peakflow meter and instructions on its use and record-keeping.

A nurse will be responsible for managing and monitoring the patients using the application. Patients will also schedule and review the medical records of all patients included in the study and review the data collection notebooks and informed consents. The asthma specialist nurse will be responsible for conducting the questionnaires, collecting data for the Case Report Form (CRF), performing laboratory tests, and conducting respiratory functional tests.

During the three study visits, all included patients will complete the study questionnaires: Asthma Control Test (ACT), Inhaler Adherence Test (TAI), Asthma Quality of Life Questionnaire (AQLQ), and the Hospital Anxiety and Depression Scale (HAD). Afterward, the electronic history of medication dispenses will be reviewed, exhaled nitric oxide (FeNO) will be measured, a spirometry test with bronchodilator response, a control blood test, and an on-site measurement of Peak Expiratory Flow (PEF) using the Peakflow meter will be conducted.

At the end of the first visit, all participants will be scheduled for the next visit and provided with a contact phone number in case the patients have any questions or issues.

Upon completion of the third visit, the intervention group will be given a satisfaction questionnaire for having used the application."

All relevant study data will be recorded in each patient's data collection notebook for subsequent analysis. These notebooks will be stored at the center in a locked room accessible only to the research team. Sociodemographic variables will be collected by the asthma unit nurse during the first study visit.

Information about the current state of asthma will be obtained through questionnaires, respiratory functional tests, laboratory tests, and a review of the patient's medical history.

Data Analysis: Continuous variables will be expressed as mean and standard deviation in case of a normal distribution, and as median and interquartile range in case of a non-normal distribution. Qualitative variables will be presented as frequencies and percentages. For the comparison of continuous variables, analysis of variance (ANOVA) or the Kruskal-Wallis test will be used. The chi-square test will be performed for the analysis of the primary outcome variable. Stepwise logistic regression models will be used to select the subgroup of parameters significantly associated with poor asthma control. A priori, the factors included in the analysis will be age, asthma duration, education level, BMI, smoking, environmental exposure, pre-BD FEV1, post-BD FEV1, FeNO, blood eosinophilia, general and specific blood IgE levels, ACT, TAI, HAD, AQLQ, the number of exacerbations, and control of comorbidities affecting asthma (GERD, rhinitis, polyps, overweight/obesity, and smoking). Statistical significance will be assumed at p \< 0.05.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years with a diagnosis of asthma based on GEMA 5.2 2022.
* Patients seen in the pulmonology service of the center.
* Patients who have not previously received asthma education.
* Capable of giving signed informed consent.

Exclusion Criteria:

* Patient who does not have a mobile device with Android or IOS system.
* Lack of minimum technological knowledge for the use of the application (ESTOI).
* People who are participating or have participated in a clinical trial in the last 6 months.
* Patients diagnosed with other respiratory diseases except for obstructive sleep apnea (OSA), Asthma-COPD overlap syndrome (ACOS).
* Patients with palliative or severe chronic illnesses that limit their life expectancy.

Primary outcomes:
measure: Asthma Control Test (ACT)
timeFrame: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
measure: Number of exacerbations
timeFrame: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52).
measure: Peak Expiratory Flow (PEF)
timeFrame: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
measure: Forced expiratory volume in one second (FEV1)
timeFrame: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
Secondary outcomes:
measure: Test of the Adherence to Inhalers (TAI).
timeFrame: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
measure: Electronic history of medication dispenses
timeFrame: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: Visit 1 (week 0), visit 2 (week 26) and visit 3 (week 52)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Bellvitge University Hospital
Study officials:
affiliation: Hospital Universitari de Bellvitge
name: Héctor Cabrerizo Carreño, M.N
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari de Bellvitge
name: Mariana M Muñoz, M.D.
role: STUDY_DIRECTOR
References:
citation: GBD 2015 Chronic Respiratory Disease Collaborators. Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Respir Med. 2017 Sep;5(9):691-706. doi: 10.1016/S2213-2600(17)30293-X. Epub 2017 Aug 16.
citation: Plaza V, Quirce S, Delgado J, Martinez Moragon E, Perez de Llano L; Grupo multidisciplinar de expertos "Asmaforum". [Multidisciplinary expert discussion. Uncontrolled asthma: causes, consequences and possible solutions]. An Sist Sanit Navar. 2016 Nov 21;39(3):357-370. doi: 10.23938/ASSN.0233. Spanish.
citation: Rabe KF, Adachi M, Lai CK, Soriano JB, Vermeire PA, Weiss KB, Weiss ST. Worldwide severity and control of asthma in children and adults: the global asthma insights and reality surveys. J Allergy Clin Immunol. 2004 Jul;114(1):40-7. doi: 10.1016/j.jaci.2004.04.042.
citation: Quirce S, Plaza V, Picado C, Vennera M, Casafont J. Prevalence of uncontrolled severe persistent asthma in pneumology and allergy hospital units in Spain. J Investig Allergol Clin Immunol. 2011;21(6):466-71.
citation: Almonacid Sanchez C, Blanco Aparicio M, Dominguez Ortega J, Giner Donaire J, Molina Paris J, Sanchez Marcos N, Plaza V. [Multidisciplinary Consensus for the Monitoring and Control of Asthma Through Telemedicine. The COMETA Project]. Open Respir Arch. 2021 Apr 19;3(2):100098. doi: 10.1016/j.opresp.2021.100098. eCollection 2021 Apr-Jun. Spanish.
citation: Marcano Belisario JS, Huckvale K, Greenfield G, Car J, Gunn LH. Smartphone and tablet self management apps for asthma. Cochrane Database Syst Rev. 2013 Nov 27;2013(11):CD010013. doi: 10.1002/14651858.CD010013.pub2.
citation: Hollenbach JP, Cushing A, Melvin E, McGowan B, Cloutier MM, Manice M. Understanding clinicians' attitudes toward a mobile health strategy to childhood asthma management: A qualitative study. J Asthma. 2017 Sep;54(7):754-760. doi: 10.1080/02770903.2016.1263649. Epub 2016 Nov 23.
citation: Munteanu LA, Frandes M, Timar B, Tudorache E, Fildan AP, Oancea C, Tofolean DE. The efficacy of a mobile phone application to improve adherence to treatment and self-management in people with chronic respiratory disease in Romanian population - a pilot study. BMC Health Serv Res. 2020 May 27;20(1):475. doi: 10.1186/s12913-020-05340-0.
citation: Guan Z, Sun L, Xiao Q, Wang Y. Constructing an assessment framework for the quality of asthma smartphone applications. BMC Med Inform Decis Mak. 2019 Oct 15;19(1):192. doi: 10.1186/s12911-019-0923-8.
citation: Farzandipour M, Nabovati E, Heidarzadeh Arani M, Akbari H, Sharif R, Anvari S. Enhancing Asthma Patients' Self-Management through Smartphone-Based Application: Design, Usability Evaluation, and Educational Intervention. Appl Clin Inform. 2019 Oct;10(5):870-878. doi: 10.1055/s-0039-1700866. Epub 2019 Nov 13.
citation: Morrison D, Wyke S, Agur K, Cameron EJ, Docking RI, Mackenzie AM, McConnachie A, Raghuvir V, Thomson NC, Mair FS. Digital asthma self-management interventions: a systematic review. J Med Internet Res. 2014 Feb 18;16(2):e51. doi: 10.2196/jmir.2814.
citation: Thomas M, Kay S, Pike J, Williams A, Rosenzweig JR, Hillyer EV, Price D. The Asthma Control Test (ACT) as a predictor of GINA guideline-defined asthma control: analysis of a multinational cross-sectional survey. Prim Care Respir J. 2009 Mar;18(1):41-9. doi: 10.4104/pcrj.2009.00010.
citation: Plaza V, Fernandez-Rodriguez C, Melero C, Cosio BG, Entrenas LM, de Llano LP, Gutierrez-Pereyra F, Tarragona E, Palomino R, Lopez-Vina A; TAI Study Group. Validation of the 'Test of the Adherence to Inhalers' (TAI) for Asthma and COPD Patients. J Aerosol Med Pulm Drug Deliv. 2016 Apr;29(2):142-52. doi: 10.1089/jamp.2015.1212. Epub 2015 Jul 31.
citation: Perpina M, Belloch A, Pascual LM, de Diego A, Compte L. [The quality of life in asthma: an evaluation of the AQLQ questionnaire for its use on a Spanish population. Asthma Quality of Life Questionnaire]. Arch Bronconeumol. 1995 May;31(5):211-8. doi: 10.1016/s0300-2896(15)30926-1. Spanish.
citation: Reddel HK, Marks GB, Jenkins CR. When can personal best peak flow be determined for asthma action plans? Thorax. 2004 Nov;59(11):922-4. doi: 10.1136/thx.2004.023077.
citation: Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available.
citation: Lu Z, Huang W, Wang L, Xu N, Ding Q, Cao C. Exhaled nitric oxide in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2018 Aug 30;13:2695-2705. doi: 10.2147/COPD.S165780. eCollection 2018.
citation: Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009 Oct;124(4):719-23.e1. doi: 10.1016/j.jaci.2009.06.053. Epub 2009 Sep 19.
citation: Kolmodin MacDonell K, Naar S, Gibson-Scipio W, Lam P, Secord E. The Detroit Young Adult Asthma Project: Pilot of a Technology-Based Medication Adherence Intervention for African-American Emerging Adults. J Adolesc Health. 2016 Oct;59(4):465-71. doi: 10.1016/j.jadohealth.2016.05.016. Epub 2016 Jul 27.
citation: Patel MR, Song PX, Sanders G, Nelson B, Kaltsas E, Thomas LJ, Janevic MR, Hafeez K, Wang W, Wilkin M, Johnson TR, Brown RW. A randomized clinical trial of a culturally responsive intervention for African American women with asthma. Ann Allergy Asthma Immunol. 2017 Feb;118(2):212-219. doi: 10.1016/j.anai.2016.11.016. Epub 2016 Dec 27.
citation: Kim MY, Lee SY, Jo EJ, Lee SE, Kang MG, Song WJ, Kim SH, Cho SH, Min KU, Ahn KH, Chang YS. Feasibility of a smartphone application based action plan and monitoring in asthma. Asia Pac Allergy. 2016 Jul;6(3):174-80. doi: 10.5415/apallergy.2016.6.3.174. Epub 2016 Jul 28.
citation: Zairina E, Abramson MJ, McDonald CF, Li J, Dharmasiri T, Stewart K, Walker SP, Paul E, George J. Telehealth to improve asthma control in pregnancy: A randomized controlled trial. Respirology. 2016 Jul;21(5):867-74. doi: 10.1111/resp.12773. Epub 2016 Mar 31.
citation: Pool AC, Kraschnewski JL, Poger JM, Smyth J, Stuckey HL, Craig TJ, Lehman EB, Yang C, Sciamanna CN. Impact of online patient reminders to improve asthma care: A randomized controlled trial. PLoS One. 2017 Feb 3;12(2):e0170447. doi: 10.1371/journal.pone.0170447. eCollection 2017.
citation: Khusial RJ, Honkoop PJ, Usmani O, Soares M, Simpson A, Biddiscombe M, Meah S, Bonini M, Lalas A, Polychronidou E, Koopmans JG, Moustakas K, Snoeck-Stroband JB, Ortmann S, Votis K, Tzovaras D, Chung KF, Fowler S, Sont JK; myAirCoach study group. Effectiveness of myAirCoach: A mHealth Self-Management System in Asthma. J Allergy Clin Immunol Pract. 2020 Jun;8(6):1972-1979.e8. doi: 10.1016/j.jaip.2020.02.018. Epub 2020 Mar 3.
citation: Cao Y, Lin SH, Zhu D, Xu F, Chen ZH, Shen HH, Li W. WeChat Public Account Use Improves Clinical Control of Cough-Variant Asthma: A Randomized Controlled Trial. Med Sci Monit. 2018 Mar 14;24:1524-1532. doi: 10.12659/msm.907284.
citation: Prabhakaran L, Chun Wei Y. Effectiveness of the eCARE programme: a short message service for asthma monitoring. BMJ Health Care Inform. 2019 Jun;26(1):e100007. doi: 10.1136/bmjhci-2019-100007.
citation: Nemanic T, Sarc I, Skrgat S, Flezar M, Cukjati I, Marc Malovrh M. Telemonitoring in asthma control: a randomized controlled trial. J Asthma. 2019 Jul;56(7):782-790. doi: 10.1080/02770903.2018.1493599. Epub 2018 Sep 5.
citation: Ahmed S, Ernst P, Bartlett SJ, Valois MF, Zaihra T, Pare G, Grad R, Eilayyan O, Perreault R, Tamblyn R. The Effectiveness of Web-Based Asthma Self-Management System, My Asthma Portal (MAP): A Pilot Randomized Controlled Trial. J Med Internet Res. 2016 Dec 1;18(12):e313. doi: 10.2196/jmir.5866.
citation: Koufopoulos JT, Conner MT, Gardner PH, Kellar I. A Web-Based and Mobile Health Social Support Intervention to Promote Adherence to Inhaled Asthma Medications: Randomized Controlled Trial. J Med Internet Res. 2016 Jun 13;18(6):e122. doi: 10.2196/jmir.4963.
citation: Chongmelaxme B, Lee S, Dhippayom T, Saokaew S, Chaiyakunapruk N, Dilokthornsakul P. The Effects of Telemedicine on Asthma Control and Patients' Quality of Life in Adults: A Systematic Review and Meta-analysis. J Allergy Clin Immunol Pract. 2019 Jan;7(1):199-216.e11. doi: 10.1016/j.jaip.2018.07.015. Epub 2018 Jul 25.