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Chronic Obstructive Pulmonary Disease (COPD)NCT06888557

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

A study testing Smartphone-based self-management support program ( 3S-C) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Hong Kong Metropolitan University at 3 sites in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Smartphone-based self-management support program ( 3S-C)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
3 sitesHong Kong
Study dates
19 Mar 2025to 31 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Agnes YK Lai, PhD contact

(852)3970-2917

ayklai@hkmu.edu.hk

George OC Cheung, MSc contact

(852)3970-2917

occheung@hkmu.edu.hk

Hong Kong3 sites, 3 recruiting
  • Queen Mary Hospital

    Hong Kong, Hong Kong

    Agnes YK Lai, PhD, ayklai@hkmu.edu.hk

    Not yet recruiting
  • Queen Elizbeth Hospital

    Hong Kong

    Maggie PK Lit, MN, blpkm01@ha.org.hk

    Recruiting
  • United Christian Hospital

    Hong Kong

    Shu Wah Ng, MSc, ngsw1@ha.org.hk

    Recruiting

Other trials in Hong Kong

About this study

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

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:

Read more
  • 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.

Read the 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.

Being tested
Smartphone-based self-management support program ( 3S-C)
Keywords
COPD, Chronic Obstructive Pulmonary Disease, self-management, digital, mobile, smartphone, QOL, quality of life, mixed-method
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smartphone-based self-management support program ( 3S-C)Behavioural

    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.

Study groups in NCT06888557
Study groupRoleWhat they receive
The General Hygiene (GHI) groupNo interventionThe 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) groupActive comparatorThe 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.
Receives: Behavioral: Smartphone-based self-management support program ( 3S-C)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, month 4

Secondary outcomes (22)
  1. 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.

    Measured: Baseline, month 12

  2. 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.

    Measured: Baseline, month 4 and 12

  3. 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.

    Measured: Baseline, month 4 and 12

  4. 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.

    Measured: Baseline, month 4 and 12

  5. 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;

    Measured: Baseline, month 4 and 12

  6. 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.

    Measured: Baseline, month 4 and 12

  7. 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.

    Measured: Baseline, month 4 and 12

  8. 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.

    Measured: Baseline, month 4 and 12

  9. Change in dietary habit

    Measured by 10-item dietary intake and practice outcome based questions

    Measured: Baseline, month 4 and 12

  10. Change in dyspnea severity

    Measured by a 1-item MRC dyspnoea scale ranging from 1 to 10. Higher score shows more dyspnoea

    Measured: Baseline, month 4 and 12

  11. 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).

    Measured: Baseline, month 4 and 12

  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.

    Measured: Baseline, month 4 and 12

  13. 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.

    Measured: Baseline, month 4 and 12

  14. 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.

    Measured: Baseline, month 4 and 12

  15. Health care resource utilization

    assessed by number of hospitalizations, primary and secondary care visits, number of unscheduled admissions; and length of hospital stay.

    Measured: Baseline, month 4 and 12

  16. 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

    Measured: Baseline, month 4 and 12

  17. 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.

    Measured: Baseline, month 4 and 12

  18. Change in grip strength

    measured by dynamometer

    Measured: Baseline, month 4 and 12

  19. 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.

    Measured: Baseline, month 4 and 12

  20. 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.

    Measured: Baseline, month 4 and 12

  21. Change in smoking and drinking habits

    Measured by self-reported smoking and drinking frequency

    Measured: Baseline, month 4 and 12

  22. Change in objective activity level

    Measured by activity tracker for 7 days to record the activity and sleep patterns

    Measured: Baseline, month 4 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2025
  2. Study start19 Mar 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06888557
Sponsor's protocol ID
HE-SF2023/04
Status last verified
Aug 2025
First submitted
11 Mar 2025
Last updated
22 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 10983477
  • 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.

    PubMed 32245961
  • 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.

    PubMed 33854327
  • 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.

    PubMed 31489206
  • 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.

    PubMed 31111039
  • 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.

    PubMed 32238810
  • 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.

    PubMed 28535331
  • 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.

    PubMed 31737348
  • 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.

    PubMed 28732818
  • 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.

    PubMed 28431503

Questions about this trial

What is this clinical trial studying?

A study testing Smartphone-based self-management support program ( 3S-C) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Hong Kong Metropolitan University at 3 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Agnes YK Lai, PhD ((852)3970-2917, ayklai@hkmu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in quality of life (time frame: Baseline, month 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06888557, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.

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