Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT06217718
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2024-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Telenursing Interventions in Empowering Patients With COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D000079102', 'term': 'Empowerment'}, {'id': 'D010358', 'term': 'Patient Participation'}], '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'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'In order to prevent selection bias in the study, the assignment to the experimental and control groups will be made on a computer by a person who is unfamiliar with the research process. Individuals included in the study will not be told whether they are in the experimental or control group. The analysis of the data will be done by a statistics expert who is outside the research process.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups with experimental and control groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-09', 'studyFirstSubmitDate': '2024-01-07', 'studyFirstSubmitQcDate': '2024-01-18', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COPD Empowerment Scale', 'timeFrame': 'Pre-test, Post-test (3rd month), Follow-up Test (6th month)', 'description': 'A 31-item scale that evaluates the impact of interventions on individuals with COPD.'}], 'secondaryOutcomes': [{'measure': 'Lung Function Test', 'timeFrame': 'Pre-test, Post-test (3rd month), Follow-up Test (6th month)', 'description': 'A spirometri test that evaluates lung capacity. FEV1 values will increase after the intervention.'}, {'measure': 'COPD Assesment Test', 'timeFrame': 'Pre-test, Post-test (3rd month), Follow-up Test (6th month)', 'description': 'It is an eight-item test that measures the effects of COPD and deterioration in health status. CAT assessment test score; 0-10 is low 11-20 is considered medium effective, 21-30 is considered highly effective, and 31-40 is considered very high effective.'}, {'measure': 'Number of hospital admissions due to COPD exacerbation', 'timeFrame': 'Pre-test, Post-test (3rd month), Follow-up Test (6th month)', 'description': 'The number of hospital admissions due to COPD exacerbation in the experimental group will decrease.'}, {'measure': 'Number of hospitalizations due to COPD exacerbation', 'timeFrame': 'Pre-test, Post-test (3rd month), Follow-up Test (6th month)', 'description': 'The number of hospitalizations due to COPD exacerbation in the experimental group will decrease.'}, {'measure': 'Modified Barthel Index', 'timeFrame': 'Pre-test, Post-test (3rd month), Follow-up Test (6th month)', 'description': 'A scale that evaluates physical competence and independence in daily living activities. It evaluates 0-15 points with 10 items. On this scale, where the possible score varies between 0 and 100, the higher the score, the more independent the patient is from other people.'}, {'measure': 'Modified Medical Research Council', 'timeFrame': 'Pre-test, Post-test (3rd month), Follow-up Test (6th month)', 'description': 'A brief 5-item scale describing dyspnea. Scores between 0 and 1 are considered mild, and scores of 2 and above are considered moderate to severe dyspnea.'}, {'measure': 'Inhaler Device Use Skill Scale', 'timeFrame': 'Pre-test, Post-test (3rd month), Follow-up Test (6th month)', 'description': 'An observational test that measures inhaler device usage skill, with 10 usage steps explained. 1 point for correct use of each item; Incomplete or incorrect use is given 0 points.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['telenursing', 'empowerment', 'Pulmonary Disease, Chronic Obstructive'], 'conditions': ['Copd', 'Empowerment', 'Empowerment, Patient', 'Self Efficacy']}, 'referencesModule': {'references': [{'pmid': '41420230', 'type': 'DERIVED', 'citation': 'Aksoy Z, Erol S, Oruc O. Effects of empowerment model-based telenursing interventions on empowerment in individuals with COPD. BMC Nurs. 2025 Dec 19. doi: 10.1186/s12912-025-04225-z. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of telenursing interventions based on the empowerment model in empowering patients with COPD.', 'detailedDescription': 'Patient empowerment is gaining importance and popularity day by day as it can be sustained through telehealth applications. The importance of using communication technologies in providing health care services has become more evident during the COVID-19 pandemic. When integrated into healthcare, technology-centric services provide continuous and easily accessible health data for patients and help facilitate self-monitoring. With tele-nursing, COPD patients can be strengthened in health literacy by teaching them how to access accurate and reliable resources. Through tele-nursing, online support groups and forums can be created among COPD patients so that patients can share their experiences with each other. In this way, social support is provided to patients who have to remain in social isolation due to their illness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a confirmed COPD diagnosis for at least one year\n* being literate,\n* Having the cognitive and mental competence to answer questions,\n* Being able to use a mobile phone,\n* Disease symptoms are at a level that does not interfere with communication,\n* Being in COPD Stage 2 and Stage 3 according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD: Global Initiative for Chronic Obstructive Lung Disease) criteria (30% ≤ FEV1 \\<80% (of expected)),\n\nExclusion Criteria:\n\n* The disease is in the acute exacerbation period,\n* Dyspnea is at a level that prevents cooperation,\n* Having sensory loss regarding vision, hearing and speech,\n* Refusal to sign informed consent forms\n* It is the refusal of the research to complete the data collection tools.'}, 'identificationModule': {'nctId': 'NCT06217718', 'briefTitle': 'The Effect of Telenursing Interventions in Empowering Patients With COPD', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'The Effect of Empowerment Model-Based Telenursing Interventions in Empowering Patients With COPD', 'orgStudyIdInfo': {'id': 'MarmaraU-HEM-ZA-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telenursing Interventions Group', 'description': 'Participants in this group will receive five hours of face-to-face empowerment training. After the training, the experimental group will be monitored remotely by the researcher nurse via tele-nursing interventions for 12 weeks. Participants will be given a pulse oximeter, symptom diary, action plan, oxygen saturation-pulse monitoring chart. Participants will be asked to measure their oxygen saturation and pulse once a day for 12 weeks and record it on the chart. Participants will also be asked to record their complaints in their symptom diary. Participants will be called by the researcher every two weeks (on Thursdays) and informative and reminding text messages prepared specifically for the disease will be sent to the participants three times a week for 12 weeks. Participants will be able to reach the researchers by phone whenever they need.', 'interventionNames': ['Other: Telenursing Interventions']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention Group', 'description': 'Participants in this group will be given a pulse oximeter, symptom diary, action plan, oxygen saturation-pulse monitoring chart. No intervention will be taken.'}], 'interventions': [{'name': 'Telenursing Interventions', 'type': 'OTHER', 'description': 'Patient follow-up with phone calls and text messages', 'armGroupLabels': ['Telenursing Interventions Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34844', 'city': 'Istanbul', 'state': 'Maltepe', 'country': 'Turkey (Türkiye)', 'facility': 'Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Zahide Aksoy, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marmara University'}, {'name': 'Saime Erol, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Marmara University'}, {'name': 'Özlem Oruç, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zahide Aksoy', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Scientific and Technological Research Council of Turkey', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Zahide Aksoy', 'investigatorAffiliation': 'Marmara University'}}}}