NCT Number: NCT06888557
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:
* Does the 3S-C program help people with COPD feel better and improve their quality of life? * Does it help them understand and manage their condition better? * Does it improve their health, such as reducing breathing problems or making it easier to sleep? * Can it reduce the need for hospital visits or other healthcare?
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:
* quality of life and how well people manage their condition. * habits like taking medication on time, exercising, eating well, or quitting smoking. * health outcomes like breathing, sleep, or feeling less anxious or depressed.
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.
Interested in participating?
Request Info40 year and older
All sexes
Interventional
Not applicable
Queen Mary Hospital, Hong Kong
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, month 4
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.
Time frame: Baseline, month 12
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.
Time frame: Baseline, month 4 and 12
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.
Time frame: Baseline, month 4 and 12
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.
Time frame: Baseline, month 4 and 12
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.
Time frame: Baseline, month 4 and 12
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;
Time frame: Baseline, month 4 and 12
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.
Time frame: Baseline, month 4 and 12
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.
Time frame: Baseline, month 4 and 12
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.
Time frame: Baseline, month 4 and 12
Measured by 10-item dietary intake and practice outcome based questions
Time frame: Baseline, month 4 and 12
Measured by a 1-item MRC dyspnoea scale ranging from 1 to 10. Higher score shows more dyspnoea
Time frame: Baseline, month 4 and 12
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).
Time frame: Baseline, month 4 and 12
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.
Time frame: Baseline, month 4 and 12
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.
Time frame: Baseline, month 4 and 12
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.
Time frame: Baseline, month 4 and 12
assessed by number of hospitalizations, primary and secondary care visits, number of unscheduled admissions; and length of hospital stay.
Time frame: Baseline, month 4 and 12
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
Time frame: Baseline, month 4 and 12
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.
Time frame: Baseline, month 4 and 12
measured by dynamometer
Time frame: Baseline, month 4 and 12
Measured by a 30-second chair stand test. The number of participant stood up repeatedly from a chair for 30 seconds.
Time frame: Baseline, month 4 and 12
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.
Time frame: Baseline, month 4 and 12
Measured by self-reported smoking and drinking frequency
Time frame: Baseline, month 4 and 12
Measured by activity tracker for 7 days to record the activity and sleep patterns
Contact information is provided by the study sponsor or research team.
Agnes YK Lai, PhD
CONTACT
George OC Cheung, MSc
CONTACT
Hong Kong Metropolitan University
Other
A Proactive Patient-centered Interactive Smartphone-based Self-Management Support Program for Patients With Chronic Obstructive Pulmonary Disease - A Pragmatic Randomized Controlled Trial With Mixed-method Evaluation
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