Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT04466020
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2020-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SELF - BREATHE for Chronic Breathlessness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D004417', 'term': 'Dyspnea'}], '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': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-01', 'studyFirstSubmitDate': '2020-07-07', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Descriptive qualitative analysis of patients' preferences, values and motivations that would influence the use of an online self - management intervention for chronic breathlessness (SELF-BREATHE).", 'timeFrame': '12 months', 'description': 'Qualitative data'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD', 'Cancer', 'Heart Failure', 'Interstitial Disease', 'Dyspnea']}, 'descriptionModule': {'briefSummary': 'Semi-structured qualitative interviews will be conducted to understand key factors that would enable / facilitate patients with chronic breathlessness to potentially use an online breathlessness intervention (SELF-BREATHE).', 'detailedDescription': "STUDY OVERVIEW\n\nFull title:\n\nA self -guided, internet -based intervention for patients with chronic breathlessness (SELF-BREATHE): an interview study.\n\nObjective:\n\nTo understand the key factors that would enable / facilitate patients with chronic breathlessness to use an online breathlessness support intervention (SELF-BREATHE).\n\nStudy type:\n\nQualitative interview study\n\nMethods:\n\nSemi-structured qualitative interviews will be conducted to achieve maximum variation in approx 20 patients with chronic breathlessness (a purposive sample: age sex, diagnoses, and presence of caregiver).\n\nThe interview will explore and identify:\n\nPatients' views/experiences of internet-based activities, e.g. digital apps, shopping online; Patients' understanding, preferences, values and motivations that would influence uptake of SELF-BREATHE; Potential barriers to the development and use of SELF-BREATHE; Facilitators to usage of SELF-BREATHE, such as the ability to self-monitor progress etc...\n\nThese topics cover areas of uncertainty in order to optimise the SELF - BREATHE intervention.\n\nInclusion criteria:\n\nAdult patients \\>18 years of age, with the ability to read, converse in English and able to provide informed consent\n\nChronic breathlessness on exertion and or rest (MRC dysponea score \\>2)\n\nAdvanced disease such as cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF) or interstitial lung disease (ILD), where the underlying disease is deemed to be optimally medically managed by the referring clinician / allied health professional / clinical nurse specialist\n\nExclusion criteria:\n\nBreathlessness of unknown cause\n\nA primary diagnosis of chronic hyperventilation syndrome"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD, Cancer, Heart Failure, Interstitial Lung disease, Dyspnea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients \\>18 years of age, with the ability to read, converse in English and able to provide informed consent\n* Chronic breathlessness on exertion and or rest (MRC dyspnea score \\>2)\n* Advanced disease such as cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF) or interstitial lung disease (ILD), where the underlying disease is deemed to be optimally medically managed by the referring clinician / allied health professional / clinical nurse specialist\n\nExclusion Criteria:\n\n* Breathlessness of unknown cause\n* A primary diagnosis of chronic hyperventilation syndrome'}, 'identificationModule': {'nctId': 'NCT04466020', 'briefTitle': 'SELF - BREATHE for Chronic Breathlessness', 'organization': {'class': 'OTHER', 'fullName': "King's College Hospital NHS Trust"}, 'officialTitle': 'A Self -Guided, Internet -Based Intervention for Patients With Chronic Breathlessness (SELF-BREATHE): an Interview Study.', 'orgStudyIdInfo': {'id': 'KCH20-056'}, 'secondaryIdInfos': [{'id': 'ICA-CL-2018-04-ST2-001', 'type': 'OTHER_GRANT', 'domain': 'HEE/NIHR Integrated Clinical Academic Programme'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Chronic Breathlessness', 'description': 'Patients with Chronic Breathlessness', 'interventionNames': ['Other: Qualitative research interviews to be conducted']}], 'interventions': [{'name': 'Qualitative research interviews to be conducted', 'type': 'OTHER', 'description': 'None. Qualitative research interviews to be conducted', 'armGroupLabels': ['Patients with Chronic Breathlessness']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Charles C Reilly, PhD,MSc,BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College Hospital NHS Trust"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}, 'collaborators': [{'name': "King's College London", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}