Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Chronic obstructive pulmonary disease, adherence, inhaled medication, self management
Brief 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 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
BEHAVIORALFull 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.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with COPD 2. Aged 40 and above 3. Had one or more severe acute exacerbations in the past year, and be in stable condition for the last 4 weeks 4. Can operate a smartphone proficiently 5. Take inhalation medication suits for the inhalation monitoring device as treatment 6. Fully understand and be willing to sign the informed consent form
Exclusion criteria
1. Certain comorbidities (e.g. unstable coronary complications) 2. Undergone thoracic, abdominal or ophthalmic surgery in recent 3 months 3. Pregnant or lactating women 4. ABS allergy history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| severe exacerbation | 12 month | Proportion of patients with severe acute exacerbation of COPD pulmonary disease during the follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First Second Forced Expiratory Volume percentage of estimated | 12 month | First Second Forced Expiratory Volume (FEV1) percentage of estimated measured by pulmonomete, % |
| peak expiratory flow | 12 month | peak expiratory flow (PEF) measured by pulmonomete, L/min |
| COPD Assessment Test score | 12 month | COPD assessment test (CAT) is an eight-item questionnaire range from 0 to 40. Higher scroe represents heavier symptom. |
| First Second Forced Expiratory Volume/ Forced Vital Capacity | 12 month | First Second Forced Expiratory Volume/Forced Vital Capacity (FEV1/FVC) measured by pulmonomete, % |
| St. George's Respiratory Questionnairefor chronic obstructive pulmonary disease (SGRQ) score | 12 month | the SGRQ scroe range from 0 to 100. 0 represents for the least and 100represents for the most. |
| peak inspiratory flow rate | 12 month | peak inspiratory flow rate (PIFR) measured by the sensor in the study |
| mild and moderate exacerbation | 12 month | Proportion of patients with mild and moderate acute exacerbation of COPD pulmonary disease during the follow-up period. |
| modified Medical Research Council scale | 12 month | 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. |
Countries
China
Contacts
Primary ContactHanna Wu, MD
Backup ContactHongtao Niu, PhD
Outcome results
None listed