Clinical trial NCT05192083: A Pilot Trial of a Smartphone-based Self-management Support Program for COPD Patients
Official title: A Pilot Trial of a Smartphone-based Self-management Support Program for Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Self-management
Support
Smartphone-based
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Self-management education and support
Primary purpose: SUPPORTIVE_CARE

Brief summary: COPD patients often experience multiple symptoms (e.g. dyspnea, cough, and deteriorating quality of life) and have imposed a substantial economic and social burden on health care.

The current proposal is to evaluate the feasibility and acceptability of a pilot trial of a smartphone-based instant messaging self-management support program to improve the quality of life in patients with COPD.

Detailed description: Chronic obstructive pulmonary disease (COPD) is the number 3 killer globally by 2020. COPD patients often experience multiple symptoms (e.g. dyspnea, cough, and deteriorating quality of life) and have imposed a substantial economic and social burden on health care.

Current policy for the prevention and management of long-term conditions focuses on efforts to prevent the onset or slow progression of disease early in the disease trajectory. This prevention paradigm has only recently been adopted for COPD. Systematic reviews have shown self-management support for patients with COPD is effective in improving health-related quality of life and in reducing hospital admissions, but the evidence comes largely from patients with moderate or severe disease and is predominantly recruited from secondary care. Simple and systematic strategies are needed to improve out-of-hospital support and management for people living with COPD.

An instant messaging smartphone app, which allows texts, audio, pictures and video messages to be shared in chat groups, is already available to and is the most popular in the Hong Kong general public. Mobile instant messaging can be conducted through a daily use device to increase access and efficacy, which has been suggested as a feasible approach to delivering an intervention with positive effects on health behaviours and outcomes. Text messaging via mobile phones has been shown to be effective in helping promote lifestyle change in diabetes self-management, weight loss, physical activity, smoking cessation and medication adherence with quantitative and qualitative evidence. However, the investigator has not found messaging intervention that was applied in people with COPD, except an ongoing study of using instant text message support for patients with chronic respiratory and cardiovascular diseases.

Hence, the current intervention program is to evaluate the feasibility and acceptability of a smartphone-based instant messaging self-management support program to improve the quality of life in patients with COPD.

Eligibility criteria: Inclusion criteria

* Aged 18 years and above
* Diagnosis with COPD
* General condition stable
* Able to speak and read Chinese
* Able to complete the self-administered questionnaire
* Able to use instant messages such as WhatsApp or WeChat
* Mental, cognitive and physically fit for joining the trial as determined by the clinician or responsible investigator
* Signed informed consent

Exclusion criteria

* Skeletal fragility
* Serious active infection
* Inability to walk
* Severe respiratory insufficiency

Primary outcomes:
measure: Change from baseline COPD-related quality of life
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change from baseline patient activation
timeFrame: Baseline, Week 8
measure: Change from baseline self-efficacy for self-management
timeFrame: Baseline, Week 8
measure: Change from baseline acceptance of illness
timeFrame: Baseline, Week 8
measure: Change from baseline medication adherence
timeFrame: Baseline, Week 8
measure: Change from baseline physical activity level
timeFrame: Baseline, Week 8
measure: Change from dyspnea severity
timeFrame: Baseline, week 8
measure: Change from baseline Health status
timeFrame: Baseline, Week 8
measure: Change from anxiety and depressive symptoms
timeFrame: Baseline, Week 8
measure: Change in baseline social support
timeFrame: Baseline, Week 8
measure: Change in from baseline sleep quality
timeFrame: Baseline, Week 8
measure: Change in baseline grip strength
timeFrame: Baseline, Week 8
measure: Change in baseline balance
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Agnes YK Lai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buttery SC, Zysman M, Vikjord SAA, Hopkinson NS, Jenkins C, Vanfleteren LEGW. Contemporary perspectives in COPD: Patient burden, the role of gender and trajectories of multimorbidity. Respirology. 2021 May;26(5):419-441. doi: 10.1111/resp.14032. Epub 2021 Mar 9.
citation: Jolly K, Sidhu MS, Hewitt CA, Coventry PA, Daley A, Jordan R, Heneghan C, Singh S, Ives N, Adab P, Jowett S, Varghese J, Nunan D, Ahmed K, Dowson L, Fitzmaurice D. Self management of patients with mild COPD in primary care: randomised controlled trial. BMJ. 2018 Jun 13;361:k2241. doi: 10.1136/bmj.k2241.
citation: Hall AK, Cole-Lewis H, Bernhardt JM. Mobile text messaging for health: a systematic review of reviews. Annu Rev Public Health. 2015 Mar 18;36:393-415. doi: 10.1146/annurev-publhealth-031914-122855.
citation: Redfern J, Hyun K, Singleton A, Hafiz N, Raeside R, Spencer L, Carr B, Caterson I, Cullen J, Ferry C, Santo K, Hayes A, Leung RWM, Raadsma S, Swinbourne J, Cho JG, King M, Roberts M, Kok C, Jenkins C, Chow C. ITM support for patients with chronic respiratory and cardiovascular diseases: a protocol for a randomised controlled trial. BMJ Open. 2019 Mar 1;9(3):e023863. doi: 10.1136/bmjopen-2018-023863.