Chronic Obstructive Pulmonary DiseaseNCT05667363
Digital Therapeutics on Inhalation Medication Adherence in COPD
A study testing Digital Intervention in people with Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
Digital Therapeutics (DTx) is an evidence-based，clinically evaluated software to treat，manage，and prevent a broad spectrum of diseases and disorders according to Digital Therapeutics Alliance，which may improve the adherence of patients with chronic obstructive pulmonary disease (COPD) to use inhaled medication and… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Digital Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 582 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand and willing to sign the written informed consent;
- Local residents diagnosed COPD by physician;
- Aged 40 and above;
- Plan to receive metered-dose inhaler as long-term treatment;
- Have a smartphone and can apply WeChat applet after training;
Who cannot join
- Certain comorbidities (e.g. unstable coronary complications);
- Undergone thoracic, abdominal or ophthalmic surgery in recent 3 months;
- Pregnant or lactating women;
- ABS allergy history.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship hospital
Beijing, Beijing Municipality
Hanna Wu, MSc, +86 15827502015, wuhanna0506@163.com
About this study
Official title: The Effect of a Digital Therapeutics Program on Inhaled Medication Adherence in Patients With Chronic Obstructive Pulmonary Disease：a Prospective, Open-label, Randomized Controlled Clinical Trial
Digital Therapeutics (DTx) is an evidence-based，clinically evaluated software to treat，manage，and prevent a broad spectrum of diseases and disorders according to Digital Therapeutics Alliance，which may improve the adherence of patients with chronic obstructive pulmonary disease (COPD) to use inhaled medication and reduce the risk of acute exacerbation. This study plans to carry out a randomized controlled trial (RCT), using digital therapy to record and manage the behavior data of patients with COPD in the process of using inhaler medication, and analyze the correlation between digital therapy of COPD and patients' drug compliance and treatment effect.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a major disease that causes death and disability worldwide. The World Health Organization (WHO) estimates that COPD has become the third leading cause of death worldwide, accounting for 6% of the global total deaths in 2019. COPD seriously affects the quality of life of patients and causes heavy economic burden to society and families.
Inhaled medication is the key treatment for COPD, and the adherence of inhaled medication is closely related to the effect of disease control. Studies have shown that incorrect and irregular use of metered-dose inhaler are very common in patients.Previous studies have shown that patients using mobile phones to record respiratory symptom diaries, and send blood oxygen saturation, heart rate, body temperature and other data, as well as changes in medication and medical treatment to the portal, and doctors access the data online to identify potential acute exacerbation and take intervention measures, can reduce the risk of acute exacerbation of COPD.
The digital therapeutics of COPD consists of patient mobile phone program, doctor management software and intelligent medication recorder. It develops a digital intervention plan for patients, helping patients intuitively and comprehensively understand the treatment plan and how to act through medication tracking reminder. It also helps doctors to view visualized patient medication, symptoms and other trend data online to understand the real treatment response of patients. This study take digital therapeutics as intervention to explore the correlation between digital therapy and patient medication adherence and treatment effect.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Digital Intervention
- Keywords
- COPD, Digital Intervention, Inhalation Medication, Adherence
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital InterventionCombination product
Digital therapeutics are consist of a smartphone app and an intelligent medication recorder. The intelligent medication recorder can automatically record medication using data and reminds patients through the app. Patients can also record their symptom on the app for doctors to monitor.
| Study group | Role | What they receive |
|---|---|---|
| Digital Intervention | Experimental | Accept metered-dose inhaler medication treatment equipped with digital therapeutics consist of smartphone app and intelligent medication recorder. The intelligent medication recorder can automatically record medication using data and reminds patients through the app. Patients can also record their symptom on the app for doctors to monitor. Receives: Combination Product: Digital Intervention |
| Usual use | No intervention | Accept regular metered-dose inhaler medication treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of adherent patients.
The proportion of patients whose TAI scores 50.
Measured: 24 weeks
Secondary outcomes (1)
Average times of AECOPD
The average times of self-reported history of AECOPD since the last follow-up
Measured: 4, 12 ,24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start20 Dec 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 582 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting YANG, China-Japan Friendship Hospital
- Investigators
- Ting Yang, MD, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667363
- Sponsor's protocol ID
- 2022-HX-43
- Status last verified
- Dec 2022
- First submitted
- 24 Oct 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Digital Therapeutics Program on Inhaled Medication Adherence in Patients With Chronic Obstructive Pulmonary Disease：a Prospective, Open-label, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05667363
- Acronym / sponsor ID
- 2022-HX-43
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Digital Intervention, Inhalation Medication, Adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 582 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 20 Dec 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Digital Therapeutics (DTx) is an evidence-based，clinically evaluated software to treat，manage，and prevent a broad spectrum of diseases and disorders according to Digital Therapeutics Alliance，which may improve the adherence of patients with chronic obstructive pulmonary disease (COPD) to use inhaled medication and reduce the risk of acute exacerbation. This study plans to carry out a randomized controlled trial (RCT), using digital therapy to record and manage the behavior data of patients with COPD in the process of using inhaler medication, and analyze the correlation between digital therapy of COPD and patients' drug compliance and treatment effect.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a major disease that causes death and disability worldwide. The World Health Organization (WHO) estimates that COPD has become the third leading cause of death worldwide, accounting for 6% of the global total deaths in 2019. COPD seriously affects the quality of life of patients and causes heavy economic burden to society and families.
Inhaled medication is the key treatment for COPD, and the adherence of inhaled medication is closely related to the effect of disease control. Studies have shown that incorrect and irregular use of metered-dose inhaler are very common in patients.Previous studies have shown that patients using mobile phones to record respiratory symptom diaries, and send blood oxygen saturation, heart rate, body temperature and other data, as well as changes in medication and medical treatment to the portal, and doctors access the data online to identify potential acute exacerbation and take intervention measures, can reduce the risk of acute exacerbation of COPD.
The digital therapeutics of COPD consists of patient mobile phone program, doctor management software and intelligent medication recorder. It develops a digital intervention plan for patients, helping patients intuitively and comprehensively understand the treatment plan and how to act through medication tracking reminder. It also helps doctors to view visualized patient medication, symptoms and other trend data online to understand the real treatment response of patients. This study take digital therapeutics as intervention to explore the correlation between digital therapy and patient medication adherence and treatment effect.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Intervention | Experimental | Combination Product: Digital InterventionAccept metered-dose inhaler medication treatment equipped with digital therapeutics consist of smartphone app and intelligent medication recorder. The intelligent medication recorder can automatically record medication using data and reminds patients through the app. Patients can also record their symptom on the app for doctors to monitor. |
| Usual use | No intervention | –Accept regular metered-dose inhaler medication treatment. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fully understand and willing to sign the written informed consent;
- Local residents diagnosed COPD by physician;
- Aged 40 and above;
- Plan to receive metered-dose inhaler as long-term treatment;
- Have a smartphone and can apply WeChat applet after training;
Key exclusion criteria (4 listed)
- Certain comorbidities (e.g. unstable coronary complications);
- Undergone thoracic, abdominal or ophthalmic surgery in recent 3 months;
- Pregnant or lactating women;
- ABS allergy history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital InterventionDigital therapeutics are consist of a smartphone app and an intelligent medication recorder. The intelligent medication recorder can automatically record medication using data and reminds patients through the app. Patients can also record their symptom on the app for doctors to monitor. | Combination product | Digital Intervention |
Primary outcome
Proportion of adherent patients.
Time frame: 24 weeks
The proportion of patients whose TAI scores 50.
1 secondary outcome
Average times of AECOPD
Time frame: 4, 12 ,24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Yang, MD principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Intervention in people with Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Yang, MD (84206272, zryyyangting@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of adherent patients. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.