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A Pilot Trial of a Smartphone-based Self-management Support Program for COPD Patients

A Pilot Trial of a Smartphone-based Self-management Support Program for Patients With Chronic Obstructive Pulmonary Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05192083
Enrollment
14
Registered
2022-01-14
Start date
2022-01-02
Completion date
2022-05-31
Last updated
2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Self-management, Support, Smartphone-based

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.

Interventions

BEHAVIORALSelf-management and Support

A smartphone-based self-management support programme includes a 30-min face-to-face or online session at baseline, 3 phone calls and 2-month mobile messages

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Self-management education and support

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline COPD-related quality of lifeBaseline, Week 8COPD symptoms and impacts and activity level were measured by an 8-item COPD Assessment Test. Total scores range from 0 to 40, with higher scores denoting a more severe impact of COPD on a patient's life.

Secondary

MeasureTime frameDescription
Change in baseline social supportBaseline, Week 8Social support measured by a 6-item Multidimensional Scale of Perceived Social Support. Each item ranges from 1 (very strongly disagree) to 7 (very strongly agree). The total score is the sum across all items divided by 6, with higher score indicating more social support.
Change in from baseline sleep qualityBaseline, Week 8Sleep quality measured by a 7-item Insomnia Severity Index. The total score range from 0 (absence of insomnia) to 28 (severe insomnia).
Change from baseline patient activationBaseline, Week 8Knowledge, skills and confidence in self-management were measured by a 13-item Patient Activation Measure Scale. The total score ranges from 0 (no activation) to 100 (high activation), with higher scores denoting the better patient activation.
Change from baseline self-efficacy for self-managementBaseline, Week 8Confidence and perceived ability of self-care were measured by a 6-item Stanford self-efficacy scale. The score for each item ranges from 1 (not at all confident) to 10 (totally confident). The total score of the scale is the mean of the six items, with higher number indicates higher self-efficacy.
Change from baseline acceptance of illnessBaseline, Week 8Acceptance of illness measured by a 8-item acceptance of illness scale. Each item ranges from 1 to 5. The total score of the scale is between 8 and 40, with low score showing a lack of adjustment to the disease, no acceptance of the condition, and mental discomfort, while high score indicating good disease acceptance.
Change in baseline balanceBaseline, Week 8Balance assessed by a single-leg stance test.
Change from baseline physical activity levelBaseline, Week 8Physical activity measured by a 7-item International Physical Activity Questionnaire-short form. Number of days and duration (in hours and minutes) engaging in vigorous activities, moderate activities, and walking in past 7 days will be collected. Duration (in hours and minutes) of sitting time on week days and weekends will be collected.
Change from dyspnea severityBaseline, week 8Dyspnea severity measured by a 1-item MRC dyspnea scale. The scale consists of five statements about perceived breathlessness: grade 1, I only get breathless with strenuous exercise; grade 2, I get short of breath when hurrying on the level or up a slight hill; grade 3, I walk slower than people of the same age on the level because of breathlessness or have to stop for breath when walking at my own pace on the level; grade 4, I stop for breath after walking 100 yards or after a few minutes on the level; grade 5, I am too breathless to leave the house. Patients selected the grade that applied to them.
Change from baseline Health statusBaseline, Week 8Health status measured by a 5-item EuroQol 5-Dimension questionnaire. The scale comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension was scored by five levels, with 1 representing no problem and 5 representing extreme problem.
Change from anxiety and depressive symptomsBaseline, Week 8Anxiety and depressive symptoms measured by a 14-item Hospital Anxiety and Depression Scale. Each item ranges from 0-3. The total scores of both Anxiety and Depression subscales range from 0-21, with higher scores indicating higher level of anxiety and depression respectively.
Change in baseline grip strengthBaseline, Week 8Grip strength of both hands measured by dynamometer
Change from baseline medication adherenceBaseline, Week 8Medication adherence measured by a 4-item Morisky Medication-Taking Adherence Scale. The scale consists of four items with a scoring scheme of Yes = 0 and No = 1. All items are summed to give a range of scores from 0 to 4, with higher score indicating a low level of medication adherence.

Countries

Hong Kong

Contacts

Primary ContactAgnes YK Lai, PhD
agneslai@hku.hk852-3917-6328
Backup ContactAsa Choi, MA
asachoi@hku.hk852-3917-6563

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026