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NCT Number: NCT06776601

Digital Therapy in Self-management of COPD Patients

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location status: Recruiting

Location contact

Hanna Wu, MD

CONTACT

[email protected]

86+15827502015

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Full process digital therapy intervention package

Behavioral

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 outcomes

  1. severe exacerbation

    Time frame: 12 month

    Proportion of patients with severe acute exacerbation of COPD pulmonary disease during the follow-up period.

Secondary outcomes

  1. First Second Forced Expiratory Volume/ Forced Vital Capacity

    Time frame: 12 month

    First Second Forced Expiratory Volume/Forced Vital Capacity (FEV1/FVC) measured by pulmonomete, %

  2. First Second Forced Expiratory Volume percentage of estimated

    Time frame: 12 month

    First Second Forced Expiratory Volume (FEV1) percentage of estimated measured by pulmonomete, %

  3. peak expiratory flow

    Time frame: 12 month

    peak expiratory flow (PEF) measured by pulmonomete, L/min

  4. COPD Assessment Test score

    Time frame: 12 month

    COPD assessment test (CAT) is an eight-item questionnaire range from 0 to 40. Higher scroe represents heavier symptom.

  5. modified Medical Research Council scale

    Time frame: 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.

  6. St. George's Respiratory Questionnairefor chronic obstructive pulmonary disease (SGRQ) score

    Time frame: 12 month

    the SGRQ scroe range from 0 to 100. 0 represents for the least and 100represents for the most.

  7. peak inspiratory flow rate

    Time frame: 12 month

    peak inspiratory flow rate (PIFR) measured by the sensor in the study

  8. mild and moderate exacerbation

    Time frame: 12 month

    Proportion of patients with mild and moderate acute exacerbation of COPD pulmonary disease during the follow-up period.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanna Wu, MD

CONTACT

[email protected]

86+15827502015

Hongtao Niu, PhD

CONTACT

[email protected]

86+15810610306

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

Digital Therapy in Self-management of Chronic Obstructive Pulmonary Disease Patients：A Prospective, Open-labled, Multicenter Randomized Controlled Clinical Study.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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