Digital Therapy in Self-management of COPD Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Full process digital therapy intervention package.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Digital Therapy in Self-management of Chronic Obstructive Pulmonary Disease Patients：A Prospective, Open-labled, Multicenter Randomized Controlled Clinical Study.
Overview
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.
Interventions
- Behavioral Full process digital therapy intervention package
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.
Primary outcome measures
- severe exacerbation [Time frame: 12 month]
Secondary outcome measures (8)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Certain comorbidities (e.g. unstable coronary complications)
- Undergone thoracic, abdominal or ophthalmic surgery in recent 3 months
- Pregnant or lactating women
- ABS allergy history
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
China · 1 center
- China Japan Friendship Hospital — Beijing
Identifiers
NCT: NCT06776601 · ZRJY2023-QM16