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

NCT06888557 | Recruiting

• 1 other identifier: HE-SF2023/04
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Chronic Obstructive Pulmonary Disease; self-management; digital; mobile; smartphone; QOL; quality of life; mixed-method

Outcome Measures

Primary Outcomes (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.

  Baseline, month 4

Secondary Outcomes (22)

• Change in quality of life

  Baseline, month 12

• Change in patient activation

  Baseline, month 4 and 12

• Change in self-efficacy for self-management

  Baseline, month 4 and 12

• Change in acceptance of illness

  Baseline, month 4 and 12

• Change in medication adherence

  Baseline, month 4 and 12

Study Arms (2)

The General Hygiene (GHI) group

NO INTERVENTION

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.

The Intervention (3S-C) group

ACTIVE COMPARATOR

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)

Interventions

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

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.

The Intervention (3S-C) group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hong Kong Metropolitan University: lead
• United Christian Hospital: collaborator
• Queen Mary Hospital, Hong Kong: collaborator
• Queen Elizabeth Hospital, Hong Kong: collaborator

Study Sites (3)

Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong

NOT YET RECRUITING

Queen Elizbeth Hospital

Hong Kong, Hong Kong

RECRUITING

United Christian Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (10)

• 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.

  PMID: 10983477 BACKGROUND

• 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.

  PMID: 32245961 BACKGROUND

• 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.

  PMID: 33854327 BACKGROUND

• 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.

  PMID: 31489206 BACKGROUND

• 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.

  PMID: 31111039 BACKGROUND

• 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.

  PMID: 32238810 BACKGROUND

• 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.

  PMID: 28535331 BACKGROUND

• 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.

  PMID: 31737348 BACKGROUND

• 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.

  PMID: 28732818 BACKGROUND

• 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.

  PMID: 28431503 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Agnes YK Lai, PhD

  Hong Kong Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnes YK Lai, PhD

CONTACT

(852)3970-2917; ayklai@hkmu.edu.hk

George OC Cheung, MSc

CONTACT

(852)3970-2917; occheung@hkmu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 21, 2025
• Study Start: March 19, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (3)