A Pilot Trial of a Smartphone-based Self-management Support Program for COPD Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Self-management and Support
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Self-management, Support, Smartphone-based
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
Sites / Locations
- Queen mary HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
The intervention group will receive a smartphone-based self-management support programme, including a 30-min face-to-face or online session at baseline, 3 phone calls (week 2, week 4 and week 6) and 2-month mobile messages in addition to usual care.
Outcomes
Primary Outcome Measures
Change from baseline COPD-related quality of life
COPD 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 Outcome Measures
Change from baseline patient activation
Knowledge, 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-management
Confidence 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 illness
Acceptance 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 from baseline medication adherence
Medication 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.
Change from baseline physical activity level
Physical 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 severity
Dyspnea 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 status
Health 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 symptoms
Anxiety 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 social support
Social 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 quality
Sleep quality measured by a 7-item Insomnia Severity Index. The total score range from 0 (absence of insomnia) to 28 (severe insomnia).
Change in baseline grip strength
Grip strength of both hands measured by dynamometer
Change in baseline balance
Balance assessed by a single-leg stance test.
Full Information
NCT ID
NCT05192083
First Posted
November 27, 2021
Last Updated
April 11, 2022
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05192083
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2022 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Self-management, Support, Smartphone-based
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Self-management education and support
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group will receive a smartphone-based self-management support programme, including a 30-min face-to-face or online session at baseline, 3 phone calls (week 2, week 4 and week 6) and 2-month mobile messages in addition to usual care.
Intervention Type
Behavioral
Intervention Name(s)
Self-management and Support
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline COPD-related quality of life
Description
COPD 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.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Change from baseline patient activation
Description
Knowledge, 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.
Time Frame
Baseline, Week 8
Title
Change from baseline self-efficacy for self-management
Description
Confidence 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.
Time Frame
Baseline, Week 8
Title
Change from baseline acceptance of illness
Description
Acceptance 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.
Time Frame
Baseline, Week 8
Title
Change from baseline medication adherence
Description
Medication 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.
Time Frame
Baseline, Week 8
Title
Change from baseline physical activity level
Description
Physical 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.
Time Frame
Baseline, Week 8
Title
Change from dyspnea severity
Description
Dyspnea 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.
Time Frame
Baseline, week 8
Title
Change from baseline Health status
Description
Health 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.
Time Frame
Baseline, Week 8
Title
Change from anxiety and depressive symptoms
Description
Anxiety 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.
Time Frame
Baseline, Week 8
Title
Change in baseline social support
Description
Social 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.
Time Frame
Baseline, Week 8
Title
Change in from baseline sleep quality
Description
Sleep quality measured by a 7-item Insomnia Severity Index. The total score range from 0 (absence of insomnia) to 28 (severe insomnia).
Time Frame
Baseline, Week 8
Title
Change in baseline grip strength
Description
Grip strength of both hands measured by dynamometer
Time Frame
Baseline, Week 8
Title
Change in baseline balance
Description
Balance assessed by a single-leg stance test.
Time Frame
Baseline, Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnes YK Lai, PhD
Phone
852-3917-6328
Email
agneslai@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Asa Choi, MA
Phone
852-3917-6563
Email
asachoi@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes YK Lai, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen mary Hospital
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnes Lai, PhD
Phone
93176779
Email
agneslai@hku.hk
First Name & Middle Initial & Last Name & Degree
David Lam, PhD
Phone
2255-4455
Email
slnga@hku.hk
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Need to obtain consent from patients before agreeing to share individual participants data.
IPD Sharing Time Frame
When study finished
IPD Sharing Access Criteria
The minimal anonymized dataset will be available upon request to interested researchers. For interested researchers, please contact, Ms Asa Choi (email asachoi@hku.hk), (School of Nursing, The University of Hong Kong) for further information.
Citations:
PubMed Identifier
33751727
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.
Results Reference
background
PubMed Identifier
29899047
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.
Results Reference
background
PubMed Identifier
25785892
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.
Results Reference
background
PubMed Identifier
30826759
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.
Results Reference
background
Links:
URL
https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death
Description
The top 10 causes of death
Learn more about this trial
A Pilot Trial of a Smartphone-based Self-management Support Program for COPD Patients
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