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Electronic patient-reported outcome monitoring–guided acupuncture added to usual care for COPD management: a protocol for a multicenter randomized controlled trial

A Digital Chronic Disease Management Model for COPD Acupuncture Intervention Based on Patient-Reported Outcomes-A Multicenter Randomized Controlled Trial of an ePRO-Based Intelligent Alert System for Acupuncture Management of Chronic Obstructive Pulmonary Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001109
Enrollment
Unknown
Registered
2026-04-28
Start date
2026-05-31
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Ususal Care:Usual care for COPD
ePRO-Guided Acupuncture :Usual care for COPD+ePRO-Guided Acupuncture

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 40–80 years; 2. Patients with Stage II, III, or IV COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and with a forced expiratory volume in one second (FEV1) between 25% and 80% of the predicted value; 3. No acute exacerbation and no sign of edema within 4 weeks prior to enrollment; 4. Receiving stable treatment according to GOLD recommendations for at least 3 months prior to enrollment, with no changes in the treatment regimen. 5. Able to walk independently and perform activities of daily living; 6. At least one hospital visit or consultation at a respiratory clinic for COPD within the past 12 months; 7. Informed consent obtained from patients or their legal representatives.

Exclusion criteria

Exclusion criteria: 1) Patients with language, memory, cognitive or psychiatric disorders, or with limited education that may prevent them from understanding them questionnaires or operating electronic tools; 2) Patient with following comorbidities: chronic heart failure, autoimmune diseases, chronic renal failure, chronic hepatic failure, or malignant tumors. 3) Patients with the following respiratory diseases: active pulmonary tuberculosis, bronchial asthma, severe bronchiectasis, or interstitial lung disease; 4) History of lung surgery for COPD, including segmentectomy, wedge resection, lobectomy, pneumonectomy, or lung volume reduction surgery (including bronchoscopic lung volume reduction); 5) Patients requiring long-term oxygen therapy (LTOT) (oxygen therapy >15 hours/day). 6) Current participation of another clinical trials or has participated in other clinical trials within 90 days preceding trial inclusion; 7) History of any acupuncture treatment in the prior 1 month; 8) Unable to administer acupuncture due to local skin infection at or near the acupoints, limb defects, or other conditions; 9) Women who are pregnant or in lactation.

Design outcomes

Primary

MeasureTime frame
Time from randomization to first COPD-related hospitalization;

Secondary

MeasureTime frame
Annual COPD-related hospitalization/ER visits;Annual self-reported COPD exacerbations;COPD-related mortality within 1 year;All-cause mortality within 1 year;SGRQ score change from baseline to 12 months;FEV1% predicted change from baseline to 12 months;the Borg scale score after the 6-minute walk test from baseline to 12 months;

Countries

China

Contacts

Public ContactWang Yuting

Chengdu University of Traditional Chinese Medicine

yutingwang1991@outlook.com18502841879

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026