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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Change in quality of life [Time frame: Baseline, month 4]

Secondary outcome measures (12)

• Change in quality of life [Time frame: Baseline, month 12]
• Change in patient activation [Time frame: Baseline, month 4 and 12]
• Change in self-efficacy for self-management [Time frame: Baseline, month 4 and 12]
• Change in acceptance of illness [Time frame: Baseline, month 4 and 12]
• Change in medication adherence [Time frame: Baseline, month 4 and 12]
• Change in PAP treatment adherence (optional for those using PAP machine) [Time frame: Baseline, month 4 and 12]
• Change in inhaler technique [Time frame: Baseline, month 4 and 12]
• Change in physical activity level [Time frame: Baseline, month 4 and 12]
• Change in dietary habit [Time frame: Baseline, month 4 and 12]
• Change in dyspnea severity [Time frame: Baseline, month 4 and 12]
• Change in exacerbation [Time frame: Baseline, month 4 and 12]
• Change in health status [Time frame: Baseline, month 4 and 12]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Hong Kong · 3 centers

• Queen Mary Hospital — Hong Kong
• Queen Elizbeth Hospital — Hong Kong
• United Christian Hospital — Hong Kong

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 31737348

Identifiers

NCT: NCT06888557 · HE-SF2023/04

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗