Digital Tool for Improved Self-management of COPD

Обзор

Primary aim: To evaluate the feasibility, usability and safety of the investigational device in clinical practice over 6 months in 50 patients. Secondary aims: To describe the number of healthcare contacts and the adequacy of those contacts. Study design: Traditional feasibility clinical investigationPilot feasibility open observational study. Subjects: 50 subjects being investigated for or with a diagnosis of COPD with at least one exacerbation within the last year will be invited to voluntarily participate. Exclusion criteria is severe disease from either COPD or any severe concomitant conditions that would make home spirometry unsafe for the patient. Patients with no access to use BankID or similar electronic personal identification service and not using Android (version 8+) or iOS (version 16+) smartphones will be excluded. Intervention: At inclusion patients will be on-boarded on to the digital platform and recommended to follow instructions in the app. The intervention is the COPD Treatment check, which is a medical device that is connected to a spirometer. Patients will be instructed to self-test on a daily basis. Control group: There will be no control group. Primary endpoints: • Feasability and usability of the system in a clinical setting as determined by usage and questionnaire evaluation. Feasibility measured by proportion of participants who complete the study, compliance and adoption (system usage), time needed to train users Secondary endpoints: * Safety of the device \- Experienced usability and the number of adverse events * Adequacy of the participant's healthcare contacts. * Number of actual clinic contacts in relation to the number of recommendations by the COPD treatment check to seek medical attention. Exacerbations (as defined by healthcare staff) * Evaluation of questionnaires (healthcare and patient reported)

Подробное описание

Patient "education" often takes the form of providers giving didactic Information and assumes that knowledge will lead to behavioural change. Although important, it may not be sufficient for promoting self-management skills. Enhancing patient knowledge is an important step towards behaviour change using self-management interventions and should include topics such as smoking cessation, correct use of inhaler devices, early recognition of exacerbations, decision-making and acting at the right time, and when to seek help. Personalized education and training that takes into account specific issues relating to the individual patient, and that aims to enhance long-term functionality and appropriate health behaviours are likely to benefit patients more. A good COPD self-management intervention is structured but personalized, with goals of motivating, engaging and supporting the patients to positively adapt their health behaviour(s) and develop skills to better manage their disease. The aim is to elicit patient motivation, confidence and competence. Systematic reviews have provided evidence that self-management interventions improve outcomes in COPD. A 2022 Cochrane review reported that interventions for people with COPD are associated with improvements in health-related quality of life (HRQoL), a lower probability of respiratory-related hospital admissions, and no excess respiratory-related and all-cause mortality risks.

One of the most important goals for treatment of COPD exacerbations are to minimize the negative impact of an exacerbation and to prevent subsequent events. Also, it is now recognized that many exacerbations are not reported to healthcare professionals for therapy and yet these events have a significant impact on health status. Thus, one focus is for COPD patients to receive education about the importance of understanding exacerbation symptoms and when to seek professional healthcare.

According to the Swedish National Board of Health and Welfare a written self-management plan should be established together with the healthcare team and be reevaluated at follow-up visits. The plan should contain information on how to adjust treatment according to for example symptoms and infections, and when it is important for the patient to contact healthcare for assistance.

The investigational device is a separate module, COPD Treatment check, embedded in the cloud-based CE-marked system called AsthmaTuner. Our hypothesis is that this digital tool will improve self-management of COPD. Thus, the aim of this study is to assess the feasibility, usability and safety of the COPD Treatment check in clinical practice. Secondary aim is to evaluate the number of healthcare contacts and the adequacy of those contacts.

At baseline, a trained nurse will onboard and instruct patients in device handling (standard education). According to a flow algorithm, the app will instruct patients to contact their healthcare provider. The healthcare provider will be able to see collected data that is displayed in the back-end system but will not be instructed to actively monitor patients.

Data on feasibility, safety and experienced usability of the investigational device will be presented. The analysis of feasibility and the experienced benefit of using the COPD Treatment check in clinical practice is estimated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree), and presented as mean and median scores. The number of clinic contacts will be presented in relation to the number of times that the app has recommended such contacts. A medical doctor will categorize the contacts as correct or incorrect, without knowing whether the contacts were initiated via the app or the patient themselves to avoid bias.

Вмешательства

• Устройство COPD treatment check
  The investigational device is designed to support self-management of COPD. It provided patients with remote individualized feedback and recommendations for symptom relief and exacerbation management based on actual lung function and symptom report.

Первичные конечные точки

• The rate of participants that perceives the device feasible to use. [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Adequacy of the participant's healthcare contacts and adverse events. [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Subjects from the age of 40 years with documented diagnosis of COPD, using at least two inhaled medications (one combination inhaler or several inhalers), and with at least one exacerbation within the last year will be invited to voluntarily participate.

Критерии исключения

• Exclusion criteria is severe disease from either COPD or any severe concomitant conditions that would make home spirometry unsafe for the patient. Patients with no access to use BankID or similar electronic personal identification service and not using smartphones will be excluded. Also, individuals who are pregnant or breastfeeding women, and individuals who are unable to provide informed consent due to cognitive impairment or other reasons indicating lack of decision-making capacity will be excluded.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Швеция · 1 центр

• KPE Lung and Allergy, QB:84, Karolinska University Hospital. — Solna

Публикации

• Breckner A, Roth C, Glassen K, Wensing M. Self-management perspectives of elderly patients with multimorbidity and practitioners - status, challenges and further support needed? BMC Fam Pract. 2021 Nov 26;22(1):238. doi: 10.1186/s12875-021-01584-9. PMID 34836506
• Human D, Crawley F, IJesselmuiden C. Revised declaration of Helsinki. WMA will continue to revise policy as medicine and research changes. BMJ. 2001 Aug 4;323(7307):283-4. No abstract available. PMID 11505938
• Williams V, Price J, Hardinge M, Tarassenko L, Farmer A. Using a mobile health application to support self-management in COPD: a qualitative study. Br J Gen Pract. 2014 Jul;64(624):e392-400. doi: 10.3399/bjgp14X680473. PMID 24982491
• Chau JP, Lee DT, Yu DS, Chow AY, Yu WC, Chair SY, Lai AS, Chick YL. A feasibility study to investigate the acceptability and potential effectiveness of a telecare service for older people with chronic obstructive pulmonary disease. Int J Med Inform. 2012 Oct;81(10):674-82. doi: 10.1016/j.ijmedinf.2012.06.003. Epub 2012 Jul 11. PMID 22789911
• Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27. PMID 22743675
• Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available. PMID 16055882
• Schoultz K, Svensson A, Emilsson M. Nurses' experiences of using AsthmaTuner - an eHealth self-management system for healthcare of patients with asthma. Digit Health. 2022 Apr 11;8:20552076221092542. doi: 10.1177/20552076221092542. eCollection 2022 Jan-Dec. PMID 35433019
• Ljungberg H, Carleborg A, Gerber H, Ofverstrom C, Wolodarski J, Menshi F, Engdahl M, Eduards M, Nordlund B. Clinical effect on uncontrolled asthma using a novel digital automated self-management solution: a physician-blinded randomised controlled crossover trial. Eur Respir J. 2019 Nov 14;54(5):1900983. doi: 10.1183/13993003.00983-2019. Print 2019 Nov. PMID 31481605

Идентификаторы

NCT: NCT07573098 · CIV-24-12-050346

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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