DOI: 10.6084/m9.figshare.28684955.v1
title: <b>Data of health education intervention for COPD patients</b>

description: Adherence to treatment is critical to effective management of COPD and is key to addressing the growing burden of disease. So, this study condcuted to evaluate the effectiveness of a health education intervention on treatment adherence behavior of COPD outpatients and identify the level of health status improvement.A random control trial was conducted in 2022 at two respiratory outpatient clinics in Da Nang City, Vietnam with the identification number is TCTR20240526001. 90 participants were divided into two group, 45 members of the health education group who received 5-times consulting about disease knowledge, training using inhallers, breathing exercises at clinic, then 12-times tele-consultation; and 45 controls who only joined surveys. Treatment adherence and level of health status improvement were assessed as outcomes.<b>Inclusion criteria</b><b>: </b>Patients were diagnosed with COPD according to GOLD 2018 criteria; Received stable home treatment with inhaled medications; No acute episodes, including acute episodes due to chronic diseases requiring hospitalization for at least 3 months; Able to speak, read and understand Vietnamese; Participants had and knew how to use a smartphone with an Internet connection; Voluntarily participated in the study.<b>Exclusion criteria</b>: History of bronchial asthma, allergic rhinitis, lung surgery, or respiratory diseases; People with mental disorders or other serious illnesses.<b>Research time: </b>The pre-intervention data collection period spans from April 2021 to October 2021; Content development for the intervention occurs from November 2021 to April 2022; The intervention itself takes place from April 2022 to June 2022, lasting three months; and Post-intervention assessments are conducted from July 2022 to August 2022.<b>Intervention</b>The intervention conducted from 01/03/2022 to 25/12/2022.Participants in the intervention group participated in two topical discussions with the research team at the hospital's outpatient clinic. Within 60 to 90 minutes, patients were provided with knowledge about the disease, practical skills in using inhaled drugs, instructions on breathing exercises, and self-management skills to improve their treatment adherence. The second session was conducted one week later (see Table 1). In addition, after completion, each patient would be given and instructed to maintain medicine use and breathing exercise diary. The diary was collected after the intervention ended and considered the basis for assessing participants' treatment adherence level. Face-to-face meetings were still conducted once a month for three continuously 3 months when the patient came for a regular appointment. This outline program has assessed by healthcare managers and practicing nurses with high scores of acceptability, appropriateness, and feasibility (M = 4.31; SD = 0.11) and (M = 4.37; SD = 0.12), respectively.The online home monitoring process was conducted immediately afterward and continued for 3 months. Periodically once a week during the hours of 8 - 9 am on Wednesday of the week, the research team made group phone calls (5 patients/group) via Zalo software; the time for each phone call was around 3-5 minutes and no more than 10 minutes. For patients who did not participate in the group call, the researcher called via their personal phone number to remind them to participate. The private call would be made three times, each time five minutes apart, to ensure the group call had enough participants. Participants were instructed not to tell and/or share phone calls contents with others. During these calls, each participant self-reported medication history, side effects of the drug (if any), the process of performing breathing exercises at home, common symptoms when performing therapy, number of dyspnea/weeks, amount and color of sputum. In addition, the research team also provided some health information such as measures to deal with dyspnea, reminding patients to practice these exercises, giving advice to quit smoking, practice inhalation with Sopiroball, practice coughing effectively, and reminding patients to record information in the diary, send a video of their breathing exercises for us to monitor and support. In all group phone calls, we maintained a consistent structure by implementing the exchanges mentioned above to ensure uniformity across all calls.<b>Data collection</b>The primary outcome in this study was treatment adherence (including adherence to inhaled medications and adherence to breathing exercises), and the secondary outcome was the proportion of participants with health status enhancement (assessing by disease severity, degree of dyspnea, and degree of airway obstruction). Primary and secondary outcomes were measured at study baseline and three months later. Treatment adherence was assessed in two ways, including adherent to inhaled drugs, and adherent to breathing exercises. Assessment of adherence to inhaled drugs by the Test of Adherence to Inhalers (TAI-10) that developed by Plaza et al., consisted of 10 questions [20]. Each item is based on a 5-Likert scale that ranges from 1- worst to 5 - best adherence. The total score was from 10 to 50 points, in which patients were seen as adhering with a score ranging from 46 to 50, and non-adherence for a score ≤ 45. The questionnaire was testing reliability with high score (Cronbach alpha at 0.871), and the test-retest reliability coefficient for the total sum score was 0.832 (p &lt; 0.01). Additionally, adherence to breathing exercises was assessed based on successful practice as well as maintaining the frequency of daily breathing exercises. Patients were seen as adherence if they did the correct all steps through the practice checklist of breathing exercises and did one or more times per day within 10 to 15 minutes per time, and/or gradually increased by their own ability. Non-adherence was recorded for the patient if did not maintain daily practice or maintains daily practice but practiced with "fail" result. Finally, the patient was assessed as adherence to treatment if there was concurrent adherence with inhaled drugs and breathing exercise therapy; conversely, non-adherent if adherence one of two contents or non-adherence with both. The patient’s health status was assessed through two indicators, including severity of disease and degree of airway obstruction. For the first indicator, it was assessed through the modified Medical Research Council (mMRC) scale and the COPD Assessment Test (CAT). Patients were considered "Mild disease" if mMRC 0-1 and CAT&lt;10; and severity with mMRC=2 and CAT&gt;10. The mMRC scale was tested with had good validity and reliability, while CAT scale was assessed with Cronbach’s alpha coefficient of 0.924. The second indicator was a degree of airway obstruction that was measured by a spirometer, and the result of each patient was classified as:“Mild - Moderate” with FEV1≥ 80% and 50%.