About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

130 Participants

are divided into 2 treatment groups

Group A: The General Hygiene (GHI) groupNo intervention 0 interventions

Group B: The Intervention (3S-C) groupActive comparator 1 intervention

Trial outcomes

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.

Time frame

Baseline, month 4

Secondary 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.

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

Baseline, month 4 and 12

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

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