Chronic Obstructive Pulmonary DiseaseNCT06776601
Digital Therapy in Self-management of COPD Patients
A study testing Full process digital therapy intervention package in people with Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
This project adopts a whole-process digital therapy intervention package composed of an inhalation technique assessment device, an electronic inhalant medication monitoring device and digital software to guide patients use the inhaler correctly personalizedly, record and manage the behavior data of chronic obstructive… 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?
- Full process digital therapy intervention package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients diagnosed with COPD
- Aged 40 and above
- Had one or more severe acute exacerbations in the past year, and be in stable condition for the last 4 weeks
- Can operate a smartphone proficiently
- Take inhalation medication suits for the inhalation monitoring device as treatment
- Fully understand and be willing to sign the informed consent form
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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Hanna Wu, MD, 86+15827502015, wuhanna0506@163.com
About this study
Official title: Digital Therapy in Self-management of Chronic Obstructive Pulmonary Disease Patients：A Prospective, Open-labled, Multicenter Randomized Controlled Clinical Study.
This project adopts a whole-process digital therapy intervention package composed of an inhalation technique assessment device, an electronic inhalant medication monitoring device and digital software to guide patients use the inhaler correctly personalizedly, record and manage the behavior data of chronic obstructive pulmonary disease (COPD) patients during the use of inhalant medication, and provide personalized reminders and feedback to patients according to the data. The purpose is to analyze whether this digital intervention scheme can reduce the number of acute exacerbations of COPD, improve the management effect of COPD, and reduce the burden of disease by improving the medication compliance of COPD patients.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Full process digital therapy intervention package
- Keywords
- Chronic obstructive pulmonary disease, adherence, inhaled medication, self management
- 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.
Full process digital therapy intervention packageBehavioural
Patients will receive individualized inhalation skills guidance after being tested by inhalation capacity measuring device, and be equipped with electronic inhalation monitoring devices, which can record their medication using data, reminding patients to use the medication on time, and correct their inhalation mistake. They can also check their inhalation record on their mobile phones. Clinicians can check the record every month to assess their adherence.
| Study group | Role | What they receive |
|---|---|---|
| Digital therapy intervention group | Experimental | Patients will receive individualized inhalation skills guidance after being tested by inhalation capacity measuring device, and be equipped with electronic inhalation monitoring devices, which can record their medication using data, reminding patients to use the medication on time, and correct their inhalation mistake. They can also check their inhalation record on their mobile phones. Clinicians can check the record every month to assess their adherence. Receives: Behavioral: Full process digital therapy intervention package |
| General management group | No intervention | Patients will accept regular inhaler medication direction, and equipped with electronic inhalation monitoring that can only record medication using data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
severe exacerbation
Proportion of patients with severe acute exacerbation of COPD pulmonary disease during the follow-up period.
Measured: 12 month
Secondary outcomes (8)
First Second Forced Expiratory Volume/ Forced Vital Capacity
First Second Forced Expiratory Volume/Forced Vital Capacity (FEV1/FVC) measured by pulmonomete, %
Measured: 12 month
First Second Forced Expiratory Volume percentage of estimated
First Second Forced Expiratory Volume (FEV1) percentage of estimated measured by pulmonomete, %
Measured: 12 month
peak expiratory flow
peak expiratory flow (PEF) measured by pulmonomete, L/min
Measured: 12 month
COPD Assessment Test score
COPD assessment test (CAT) is an eight-item questionnaire range from 0 to 40. Higher scroe represents heavier symptom.
Measured: 12 month
modified Medical Research Council scale
The modified Medical Research Council (mMRC) scale stands for the level of patient self-report dyspnea. 0 is the minimum and 4 is the maximum.
Measured: 12 month
St. George's Respiratory Questionnairefor chronic obstructive pulmonary disease (SGRQ) score
the SGRQ scroe range from 0 to 100. 0 represents for the least and 100represents for the most.
Measured: 12 month
peak inspiratory flow rate
peak inspiratory flow rate (PIFR) measured by the sensor in the study
Measured: 12 month
mild and moderate exacerbation
Proportion of patients with mild and moderate acute exacerbation of COPD pulmonary disease during the follow-up period.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start18 Jul 2024
- Primary completion18 Sep 2025 (estimated)
- Study completion30 Dec 2025 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongtao Niu, China-Japan Friendship Hospital
- Investigators
- Hongtao Niu, PhD, Principal investigator, China Japan Friendshi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776601
- Sponsor's protocol ID
- ZRJY2023-QM16
- Status last verified
- Jan 2025
- First submitted
- 21 Dec 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Therapy in Self-management of Chronic Obstructive Pulmonary Disease Patients：A Prospective, Open-labled, Multicenter Randomized Controlled Clinical Study.
- ClinicalTrials.gov ID
- NCT06776601
- Acronym / sponsor ID
- ZRJY2023-QM16
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, adherence, inhaled medication, self management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 18 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 Jan 2025 (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.
This project adopts a whole-process digital therapy intervention package composed of an inhalation technique assessment device, an electronic inhalant medication monitoring device and digital software to guide patients use the inhaler correctly personalizedly, record and manage the behavior data of chronic obstructive pulmonary disease (COPD) patients during the use of inhalant medication, and provide personalized reminders and feedback to patients according to the data. The purpose is to analyze whether this digital intervention scheme can reduce the number of acute exacerbations of COPD, improve the management effect of COPD, and reduce the burden of disease by improving the medication compliance of COPD patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital therapy intervention group | Experimental | Behavioral: Full process digital therapy intervention packagePatients will receive individualized inhalation skills guidance after being tested by inhalation capacity measuring device, and be equipped with electronic inhalation monitoring devices, which can record their medication using data, reminding patients to use the medication on time, and correct their inhalation mistake. They can also check their inhalation record on their mobile phones. Clinicians can check the record every month to assess their adherence. |
| General management group | No intervention | –Patients will accept regular inhaler medication direction, and equipped with electronic inhalation monitoring that can only record medication using data. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with COPD
- Aged 40 and above
- Had one or more severe acute exacerbations in the past year, and be in stable condition for the last 4 weeks
- Can operate a smartphone proficiently
- Take inhalation medication suits for the inhalation monitoring device as treatment
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 |
|---|---|---|
| Full process digital therapy intervention packagePatients will receive individualized inhalation skills guidance after being tested by inhalation capacity measuring device, and be equipped with electronic inhalation monitoring devices, which can record their medication using data, reminding patients to use the medication on time, and correct their inhalation mistake. They can also check their inhalation record on their mobile phones. Clinicians can check the record every month to assess their adherence. | Behavioural | Digital therapy intervention group |
Primary outcome
severe exacerbation
Time frame: 12 month
Proportion of patients with severe acute exacerbation of COPD pulmonary disease during the follow-up period.
8 secondary outcomes
First Second Forced Expiratory Volume/ Forced Vital Capacity
Time frame: 12 month
First Second Forced Expiratory Volume percentage of estimated
Time frame: 12 month
peak expiratory flow
Time frame: 12 month
COPD Assessment Test score
Time frame: 12 month
modified Medical Research Council scale
Time frame: 12 month
St. George's Respiratory Questionnairefor chronic obstructive pulmonary disease (SGRQ) score
Time frame: 12 month
peak inspiratory flow rate
Time frame: 12 month
mild and moderate exacerbation
Time frame: 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Hongtao Niu, PhD principal investigator
China Japan Friendshi 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 Full process digital therapy intervention package 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 6 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: looking for participants now, as of the sponsor's last update on 15 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanna Wu, MD (86+15827502015, wuhanna0506@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severe exacerbation (time frame: 12 month). 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 15 Jan 2025.