Smartphone-based Self-Management Support Program to Enhance Quality of Life in Patients With COPD

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Behavioral: Smartphone-based self-management support program ( 3S-C)

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.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agnes YK Lai, PhD; Phone Number: (852)3970-2917; Email: ayklai@hkmu.edu.hk
• Study Contact Backup: Name: George OC Cheung, MSc; Phone Number: (852)3970-2917; Email: occheung@hkmu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Not yet recruiting
    • Queen Mary Hospital
    • Contact: Agnes YK Lai, PhD; Email: ayklai@hkmu.edu.hk
  • Hong Kong, Hong Kong
    • Recruiting
    • United Christian Hospital
    • Contact: Shu Wah Ng, MSc; Email: ngsw1@ha.org.hk
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Elizbeth Hospital
    • Contact: Maggie PK Lit, MN; Email: blpkm01@ha.org.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: The General Hygiene (GHI) group; 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.
Active Comparator: The Intervention (3S-C) group; 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.	Behavioral: Smartphone-based self-management support program ( 3S-C); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Hong Kong Metropolitan University
• Collaborators: Queen Elizabeth Hospital, Hong Kong; Queen Mary Hospital, Hong Kong; United Christian Hospital
• Investigators: Principal Investigator: Agnes YK Lai, PhD, Hong Kong Metropolitan University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; COPD; self-management; smartphone; Chronic Obstructive Pulmonary Disease; QOL; mobile; digital; mixed-method
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: HE-SF2023/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No