Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:58 AM
Study NCT ID:
NCT07469904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Health Self-Management Intervention for Patient With Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in COPD health status', 'timeFrame': 'Baseline, 1 month, 2 months and 3 months', 'description': 'Health status will be assessed using the COPD Assessment Test (CAT). The outcome will be defined as the change in CAT score from baseline during the 3-month follow-up period.'}], 'secondaryOutcomes': [{'measure': 'Change in inhaler technique score', 'timeFrame': 'Baseline, 1 month, 2 months and 3 months', 'description': 'Inhaler technique will be assessed using a standardized inhaler technique checklist. The outcome will be defined as the change in inhaler technique score from baseline through 3 months, with monthly measurements.'}, {'measure': 'Change in adherence to the inhalation regimen', 'timeFrame': 'Baseline, 1 month, 2 months and 3 months', 'description': 'Adherence to the inhalation regimen will be measured as the ratio of doses taken to doses prescribed on the device. The outcome will be defined as the change in adherence rate from baseline through 3 months, with monthly measurements.'}, {'measure': 'Change in COPD-related health knowledge', 'timeFrame': 'Baseline, 1 month, 2 months and 3 months', 'description': 'COPD-related health knowledge will be measured using a structured knowledge questionnaire (Indonesian version of Health Knowledge of Lung Function Questionnaire Assessment, 25-item). The outcome will be defined as the change in knowledge score from baseline through 3 months, with monthly measurements.'}, {'measure': 'Change in dyspnea severity', 'timeFrame': 'Baseline, 1 month, 2 months, and 3 months', 'description': 'Dyspnea severity will be assessed using the modified Medical Research Council (mMRC) dyspnea scale.'}, {'measure': 'Change in respiratory quality of life', 'timeFrame': 'Baseline, 1 month, 2 months, and 3 months', 'description': "Quality of life will be assessed using the St George's Respiratory Questionnaire (SGRQ)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AERIS', 'serious games'], 'conditions': ['COPD', 'COPD (Chronic Obstructive Pulmonary Disease)']}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to evaluate the effectiveness of a pharmacist-led interactive mobile health intervention (serious game) in adults aged 50 years and older with chronic obstructive pulmonary disease (COPD). The study will test whether the intervention improves health status compared with usual care. Secondary outcomes include inhaler technique, medication adherence, health knowledge, dyspnea, clinical events, healthcare utilization, and costs. Participants in the intervention group will receive pharmacist guidance and use the serious game at home for 2 weeks.', 'detailedDescription': "Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disease that requires long-term self-management to control symptoms and prevent exacerbations. However, many patients experience difficulties in maintaining proper inhaler technique, adhering to medication, and recognizing early signs of exacerbation. Digital health interventions may provide additional support to improve patients' knowledge and self-management behaviors.\n\nThis study evaluates a pharmacist-led interactive mobile health intervention delivered through a serious game designed to support COPD self-management. The intervention includes educational content, inhaler technique training, medication reminders, and guidance on exacerbation prevention and management. Participants will receive pharmacist guidance on how to use the application and will be asked to play the game at home for two weeks.\n\nThe study is designed as a pilot randomized controlled trial comparing the serious game intervention with usual care in adults aged 50 years and older with COPD. The trial will assess whether the intervention can improve patients' self-management and health outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 50 years and older\n* Diagnosed with chronic obstructive pulmonary disease (COPD) and clinically stable at the time of enrollment\n* Receiving inhalation therapy\n* Able to use or access a smartphone\n* Able to communicate in Bahasa Indonesia\n* Willing to participate and provide informed consent\n\nExclusion Criteria:\n\n* Other respiratory diseases (active tuberculosis, lung cancer, asthma, and pneumonia)\n* Serious comorbidities (renal insufficiency and cardiac failure, terminal illness, life expectancy \\<6 m)\n* mental disorders or cognitive dysfunction\n* auditory, visual, or verbal inability\n* participation in other intervention studies'}, 'identificationModule': {'nctId': 'NCT07469904', 'acronym': 'AERIS', 'briefTitle': 'Mobile Health Self-Management Intervention for Patient With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Katolik Widya Mandala Surabaya'}, 'officialTitle': 'Evaluation of the Effectiveness of a Pharmacist-Led Interactive Mobile Health Intervention (Serious Games) for Improving Health Outcomes in Adults With COPD (Pilot RCT)', 'orgStudyIdInfo': {'id': 'AERIS-COPD-PilotRCT-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mHealth Serious Game Intervention', 'description': 'Participants will receive a pharmacist-led mobile health serious game designed to support COPD self-management. The application includes educational content, inhaler technique training, medication reminders, and guidance on exacerbation prevention and management. Participants will receive brief guidance from a pharmacist and will use the application at home for 2 weeks, with continued access during the 3-month follow-up period.', 'interventionNames': ['Behavioral: Pharmacist-Led mHealth Serious Game']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Participants will receive usual COPD care and routine education provided by healthcare professionals according to standard clinical practice.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Pharmacist-Led mHealth Serious Game', 'type': 'BEHAVIORAL', 'description': 'A mobile health serious game designed to support COPD self-management through interactive learning activities. The application provides education on COPD management, inhaler technique training, medication reminders, and guidance on recognizing and managing exacerbations.', 'armGroupLabels': ['mHealth Serious Game Intervention']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Participants will receive standard COPD care and routine education provided by healthcare professionals according to usual clinical practice.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60119', 'city': 'Surabaya', 'state': 'East Java', 'country': 'Indonesia', 'facility': 'Gotong Royong Hospital Surabaya', 'geoPoint': {'lat': -7.24917, 'lon': 112.75083}}], 'centralContacts': [{'name': 'Galuh Nawang Prawesti, Master of Clinical Pharmacy', 'role': 'CONTACT', 'email': 'galuh@ukwms.ac.id', 'phone': '+6281235111205'}], 'overallOfficials': [{'name': 'Shawn Hsiang-Yin Chen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Katolik Widya Mandala Surabaya', 'class': 'OTHER'}, 'collaborators': [{'name': 'Taipei Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Galuh Nawang Prawesti', 'investigatorAffiliation': 'Universitas Katolik Widya Mandala Surabaya'}}}}