Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-03 @ 8:40 PM
Study NCT ID:
NCT06888557
Status:
RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smartphone-based Self-Management Support Program to Enhance Quality of Life in Patients With COPD
Sponsor:
Hong Kong Metropolitan University
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: