Clinical trial NCT06888557: Smartphone-based Self-Management Support Program to Enhance Quality of Life in Patients with COPD
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Chronic Obstructive Pulmonary Disease
self-management
digital
mobile
smartphone
QOL
quality of life
mixed-method
Lead sponsor: Hong Kong Metropolitan University
Sponsor class: OTHER
Collaborators: name: United Christian Hospital
name: Queen Mary Hospital, Hong Kong
name: Queen Elizabeth Hospital, Hong Kong
First posted: 2025-03-21
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* Aged 40 years and above
* Confirmed diagnosis of COPD
* Had COPD acute exacerbation in prior 6 months that required hospitalization, medical intervention or seek medical consultation
* Mentally, cognitively and physically fit to join as determined by the doctor in-charge and responsible clinical investigators
* Can speak and read Chinese
* Completion of the Physical Activity Readiness Questionnaire
* Has a smartphone with WhatsApp or WeChat

Exclusion Criteria:

* Have other significant lung disease or Class 4 heart failure \[defined by the New York Heart Association classification\]
* Serious active infection
* Inability to walk
* Unstable psychiatric illness

Primary outcomes:
measure: Change in quality of life
timeFrame: Baseline, month 4
Secondary outcomes:
measure: Change in quality of life
timeFrame: Baseline, month 12
measure: Change in patient activation
timeFrame: Baseline, month 4 and 12
measure: Change in self-efficacy for self-management
timeFrame: Baseline, month 4 and 12
measure: Change in acceptance of illness
timeFrame: Baseline, month 4 and 12
measure: Change in medication adherence
timeFrame: Baseline, month 4 and 12
measure: Change in PAP treatment adherence (optional for those using PAP machine)
timeFrame: Baseline, month 4 and 12
measure: Change in inhaler technique
timeFrame: Baseline, month 4 and 12
measure: Change in physical activity level
timeFrame: Baseline, month 4 and 12
measure: Change in dietary habit
timeFrame: Baseline, month 4 and 12
measure: Change in dyspnea severity
timeFrame: Baseline, month 4 and 12
measure: Change in exacerbation
timeFrame: Baseline, month 4 and 12
measure: Change in health status
timeFrame: Baseline, month 4 and 12
measure: Change in subjective happiness
timeFrame: Baseline, month 4 and 12
measure: Change in sleep quality
timeFrame: Baseline, month 4 and 12
measure: Health care resource utilization
timeFrame: Baseline, month 4 and 12
measure: Change in anxiety symptoms
timeFrame: Baseline, month 4 and 12
measure: Change in functional exercise capacity
timeFrame: Baseline, month 4 and 12
measure: Change in grip strength
timeFrame: Baseline, month 4 and 12
measure: Change in lower limb muscle strength
timeFrame: Baseline, month 4 and 12
measure: Change in depression symptoms
timeFrame: Baseline, month 4 and 12
measure: Change in smoking and drinking habits
timeFrame: Baseline, month 4 and 12
measure: Change in objective activity level
timeFrame: Baseline, month 4 and 12
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Elizbeth Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: United Christian Hospital
Study officials:
affiliation: Hong Kong Metropolitan University
name: Agnes YK Lai, PhD
role: PRINCIPAL_INVESTIGATOR
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