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| Name | Class |
|---|---|
| United Christian Hospital | OTHER |
| Queen Mary Hospital, Hong Kong | OTHER |
| Queen Elizabeth Hospital, Hong Kong | OTHER |
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The goal of this study is to find out if a smartphone-based program (called 3S-C) can help people with COPD live better, healthier lives. It will also look at how the program affects their knowledge, habits, and overall health.
The main questions the study wants to answer are:
Participants will be split into two groups:
The 3S-C group: They will use the smartphone-based program, which includes: (i) Two short individual sessions to motivate them, (ii) helpful messages sent through apps like WhatsApp or WeChat; (iii) support through personalized messaging, phone calls, and a hotline; (iv) an online platform to track their health; and (v) a group session to connect with other COPD patients.
The general hygiene (control) group: They will get information about staying healthy, such as tips on hand washing, food safety, keeping their home clean, and better sleep habits.
What will participants do?
Take part in the study for 12 months. visit the clinic for checkups and complete surveys and simple fitness tests at the start, after 4 months, and after 12 months.
Researchers will check if the 3S-C program improves:
This study will compare the 3S-C program to general hygiene tips to see if using a smartphone can make living with COPD easier and healthier.
COPD is a progressive condition that worsens with age, significantly impacting patients, families, and society due to declining health status, reduced quality of life, and high healthcare utilization. Quality of life impairment remains a critical issue for individuals with COPD.
This assessor-blinded, two-armed randomized controlled trial, with a 12-month follow-up, will recruit 130 eligible patients who will be randomized in blocks of 4-6 into either the intervention group (n=65) or the control group (n=65). The intervention group will receive the 3S-C smartphone-based self-management support program, while the control group will receive general hygiene (GH) information.
The 3S-C program is designed to enhance patients' knowledge, skills, confidence, and self-management of their illness. It includes two 30-minute motivational enhancement sessions, staged WhatsApp/WeChat messages, personalized chat-based support (messaging, phone calls, and hotline services), an e-platform for self-monitoring, and a mutual support group session. In contrast, the GH program provides education on personal hygiene (e.g., hand washing), food hygiene (e.g., safe food storage), environmental hygiene (e.g., pest control), and sleep hygiene (e.g., avoiding caffeine before bedtime).
The primary objective of this trial is to evaluate the impact of the 3S-C program on quality of life in COPD patients. Secondary outcomes include improvements in health-related cognition (knowledge, self-efficacy, and acceptance of illness), behavior (medication adherence, inhalation technique, physical activity, dietary habits, and smoking cessation), clinical outcomes (dyspnea, exacerbations, exercise capacity, sleep quality, and mental health), and healthcare utilization (frequency of hospital visits and emergency care).
Data will be collected at baseline, 4 months, and 12 months through surveys and simple fitness tests. Additionally, focus group interviews will be conducted. This study will determine if the 3S-C program effectively improves quality of life and health outcomes for COPD patients while reducing healthcare utilization. If successful, the 3S-C program could provide a scalable, low-cost solution to enhance COPD management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The General Hygiene (GHI) group | No Intervention | The General Hygiene (GHI) group will not receive any intervention within the study period other than some general hygiene information, and will not join the mutual support group. | |
| The Intervention (3S-C) group | Active Comparator | The 3S-C intervention group will receive a smartphone-based self-management support program for them to motivate, actively engage and empower self-management, supplement current service, and provide remote continuous support within the study period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone-based self-management support program ( 3S-C) | Behavioral | The 3S-C include: (1) two 30-minute individual sessions ; (2) a set of instant messages, 10-minute telephone-delivered health coaching ; (3) continuous personalized chat-based messaging, phone call support, and hotline service ; (4) an e-platform for goal setting and self-monitoring ; (5) A mutual support group session. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life | Measured by an 8-item COPD Assessment Test (CAT). Each item score ranges from 0 to 5. The total score ranges from a minimum of 0 to a maximum of 40. Higher scores denote a more severe impact of COPD on a patient's life. The difference between stable and exacerbation patients was five units. No target score represents the best achievable outcome. | Baseline, month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life | Measured by an 8-item COPD Assessment Test (CAT). Each item score ranges from 0 to 5. The total score ranges from a minimum of 0 to a maximum of 40. Higher scores denote a more severe impact of COPD on a patient's life. The difference between stable and exacerbation patients was five units. No target score represents the best achievable outcome. | Baseline, month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agnes YK Lai, PhD | Contact | (852)3970-2917 | ayklai@hkmu.edu.hk | |
| George OC Cheung, MSc | Contact | (852)3970-2917 | occheung@hkmu.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Agnes YK Lai, PhD | Hong Kong Metropolitan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Not yet recruiting | Hong Kong | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10983477 | Background | Zhao H, Kanda K. Translation and validation of the standard Chinese version of the EORTC QLQ-C30. Qual Life Res. 2000 Mar;9(2):129-37. doi: 10.1023/a:1008981520920. | |
| 32245961 | Background | Ansari S, Hosseinzadeh H, Dennis S, Zwar N. Activating primary care COPD patients with multi-morbidity through tailored self-management support. NPJ Prim Care Respir Med. 2020 Apr 3;30(1):12. doi: 10.1038/s41533-020-0171-5. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Change in patient activation | Measured by a 13-item Patient Activation Measure with a 5-point Likert response scale from 0 to 4. Raw scores are transformed to a scale of 0-100 with higher scores indicating a higher activation in self-management. | Baseline, month 4 and 12 |
| Change in self-efficacy for self-management | Measured by a 6-item Stanford self-efficacy scale ranging from 1 to 10 for each item. The score for the scale is the mean of the six items. Minimum score is 1 and the maximum score is 10. If more than two items are missing, do not score the scale. Higher number indicates higher self-efficacy. | Baseline, month 4 and 12 |
| Change in acceptance of illness | Measured by an 8-item Acceptance of Illness Scale. The scale consists of 8 statements expressing specific difficulties and limitations caused by the disease. Each item ranges from 1 to 5. The total score with a minimum of 8 and a maximum of 40. | Baseline, month 4 and 12 |
| Change in medication adherence | Medication adherence was measured by a checklist and was calculated as a ratio of the number of doses taken to the number of doses prescribed; | Baseline, month 4 and 12 |
| Change in PAP treatment adherence (optional for those using PAP machine) | Information on the number of days using the PAP and total duration of machine used per day in the past 3 month will be retrieved from built-in machine record. | Baseline, month 4 and 12 |
| Change in inhaler technique | Inhaler technique assessed by a 10-item checklist with answer of "Yes" or "No" . The proportion of correctness will be calculated the number of correct step divided by the number of step expected to perform. | Baseline, month 4 and 12 |
| Change in physical activity level | Measured the days and duration of physical activity level (light, moderate and vigorous) and sitting time in the past 7 days by the International Physical Activity Questionnaire (short version) with 4 questions. | Baseline, month 4 and 12 |
| Change in dietary habit | Measured by 10-item dietary intake and practice outcome based questions | Baseline, month 4 and 12 |
| Change in dyspnea severity | Measured by a 1-item MRC dyspnoea scale ranging from 1 to 10. Higher score shows more dyspnoea | Baseline, month 4 and 12 |
| Change in exacerbation | The number of episode of exacerbation will be reported by patients (including use of self-help packs, need medical consultations or medical treatment for his/her shortness of breath). | Baseline, month 4 and 12 |
| Change in health status | Measured by 5-item EuroQol-5D Questionnaire. Each item is a different dimension that ranges from level 1-5, a higher level indicates a more severe level of perceived problem of that dimension. | Baseline, month 4 and 12 |
| Change in subjective happiness | Measured by 4-item Subjective Happiness Scale with a 7-point Likert scale. Total scores range from 4 to 28. The highest scores reflect greater happiness. | Baseline, month 4 and 12 |
| Change in sleep quality | Measured by 7-item Severe Insomnia Index. Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale. The total score ranges from 0 to 28. The higher scores the greater severity of insomnia. | Baseline, month 4 and 12 |
| Health care resource utilization | assessed by number of hospitalizations, primary and secondary care visits, number of unscheduled admissions; and length of hospital stay. | Baseline, month 4 and 12 |
| Change in anxiety symptoms | Measured by a 7-item Generalised Anxiety Disorder Assessment. Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale. The total score ranges from 0 to 21. The higher scores the greater severity of anxiety symptoms | Baseline, month 4 and 12 |
| Change in functional exercise capacity | Measured by a 6-minute walk test. The distance of participant walked with the instructions to walk back and forth at their own pace to a designated spot for 6 minutes. | Baseline, month 4 and 12 |
| Change in grip strength | measured by dynamometer | Baseline, month 4 and 12 |
| Change in lower limb muscle strength | Measured by a 30-second chair stand test. The number of participant stood up repeatedly from a chair for 30 seconds. | Baseline, month 4 and 12 |
| Change in depression symptoms | Measured by a 9-item Patient Health Questionnaire. Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale. The total score ranges from 0 to 27. The higher scores the greater severity of depression symptoms. | Baseline, month 4 and 12 |
| Change in smoking and drinking habits | Measured by self-reported smoking and drinking frequency | Baseline, month 4 and 12 |
| Change in objective activity level | Measured by activity tracker for 7 days to record the activity and sleep patterns | Baseline, month 4 and 12 |
| Queen Elizbeth Hospital | Recruiting | Hong Kong | Hong Kong |
|
| United Christian Hospital | Recruiting | Hong Kong | Hong Kong |
|
| 33854327 | Background | Kjellsdotter A, Andersson S, Berglund M. Together for the Future - Development of a Digital Website to Support Chronic Obstructive Pulmonary Disease Self-Management: A Qualitative Study. J Multidiscip Healthc. 2021 Apr 6;14:757-766. doi: 10.2147/JMDH.S302013. eCollection 2021. |
| 31489206 | Background | Slevin P, Kessie T, Cullen J, Butler MW, Donnelly SC, Caulfield B. A qualitative study of chronic obstructive pulmonary disease patient perceptions of the barriers and facilitators to adopting digital health technology. Digit Health. 2019 Aug 25;5:2055207619871729. doi: 10.1177/2055207619871729. eCollection 2019 Jan-Dec. |
| 31111039 | Background | Slevin P, Kessie T, Cullen J, Butler MW, Donnelly SC, Caulfield B. Exploring the potential benefits of digital health technology for the management of COPD: a qualitative study of patient perceptions. ERJ Open Res. 2019 May 10;5(2):00239-2018. doi: 10.1183/23120541.00239-2018. eCollection 2019 Apr. |
| 32238810 | Background | Shaw G, Whelan ME, Armitage LC, Roberts N, Farmer AJ. Are COPD self-management mobile applications effective? A systematic review and meta-analysis. NPJ Prim Care Respir Med. 2020 Apr 1;30(1):11. doi: 10.1038/s41533-020-0167-1. |
| 28535331 | Background | McCabe C, McCann M, Brady AM. Computer and mobile technology interventions for self-management in chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2017 May 23;5(5):CD011425. doi: 10.1002/14651858.CD011425.pub2. |
| 31737348 | Background | Ding H, Fatehi F, Maiorana A, Bashi N, Hu W, Edwards I. Digital health for COPD care: the current state of play. J Thorac Dis. 2019 Oct;11(Suppl 17):S2210-S2220. doi: 10.21037/jtd.2019.10.17. |
| 28732818 | Background | Rogliani P, Ora J, Puxeddu E, Matera MG, Cazzola M. Adherence to COPD treatment: Myth and reality. Respir Med. 2017 Aug;129:117-123. doi: 10.1016/j.rmed.2017.06.007. Epub 2017 Jun 13. |
| 28431503 | Background | Miravitlles M, Ribera A. Understanding the impact of symptoms on the burden of COPD. Respir Res. 2017 Apr 21;18(1):67. doi: 10.1186/s12931-017-0548-3. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |