Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-09 @ 7:57 AM
Study NCT ID:
NCT02534766
Status:
COMPLETED
Last Update Posted:
2016-09-27
First Post:
2015-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-26', 'studyFirstSubmitDate': '2015-08-25', 'studyFirstSubmitQcDate': '2015-08-25', 'lastUpdatePostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days', 'timeFrame': '6 months previous', 'description': 'To assess whether the number COPD exacerbations (prednisolone or equivalent ≥30 mg for \\>3 days or antibiotics for \\>3 days) improves in MISSION patients in the 6 months after the clinic compared with the 6 months before.'}, {'measure': 'COPD control measured by number of exacerbations treated with steroids and or antibiotics for ≥3 days', 'timeFrame': '6 months', 'description': 'To assess whether the number COPD exacerbations (prednisolone or equivalent ≥30 mg for \\>3 days or antibiotics for \\>3 days) improves in MISSION patients in the 6 months after the clinic compared with the 6 months before.'}, {'measure': 'Number of exacerbations of COPD that require hospital admission and treatment', 'timeFrame': '6 months previous', 'description': 'Number of exacerbations of COPD that require admission to hospital for treatment to assess whether hospital admissions change in the 6 months after the MISSION clinic'}, {'measure': 'Number of exacerbations of COPD that require hospital admission and treatment', 'timeFrame': '6 months', 'description': 'Number of exacerbations of COPD that require admission to hospital for treatment to assess whether hospital admissions change in the 6 months after the MISSION clinic'}], 'secondaryOutcomes': [{'measure': 'COPD Assessment Test (CAT) Score', 'timeFrame': 'baseline', 'description': 'patients will complete the CAT questionnaire to assess COPD control'}, {'measure': 'COPD Assessment Test (CAT) Score', 'timeFrame': '3 months', 'description': 'patients will complete the CAT questionnaire to assess COPD control'}, {'measure': 'COPD Assessment Test (CAT) Score', 'timeFrame': '6 months', 'description': 'patients will complete the CAT questionnaire to assess COPD control'}, {'measure': "St George's Respiratory Questionnaire (SGRQ)", 'timeFrame': 'baseline'}, {'measure': "St George's Respiratory Questionnaire (SGRQ)", 'timeFrame': '3 months'}, {'measure': "St George's Respiratory Questionnaire (SGRQ)", 'timeFrame': '6 months'}, {'measure': 'Number of non elective GP visits for COPD', 'timeFrame': '6 month previous', 'description': 'Number of non elective GP visits for COPD in the 6 months pre MISSION'}, {'measure': 'Number of non elective GP visits for COPD', 'timeFrame': '6 months', 'description': 'Number of non elective GP visits for COPD in the 6 months post MISSION'}, {'measure': 'Number of hospital admissions for COPD', 'timeFrame': '6 month previous', 'description': 'Number of hospital admissions for COPD in the 6 months pre MISSION'}, {'measure': 'Number of hospital admissions for COPD', 'timeFrame': '6 months', 'description': 'Number of hospital admissions for COPD in the 6 months post MISSION'}, {'measure': 'Number of Emergency Department contacts for COPD', 'timeFrame': '6 month previous', 'description': 'Number of Emergency Department contacts for COPD in the 6 months pre MISSION'}, {'measure': 'Number of Emergency Department contacts for COPD', 'timeFrame': '6 months', 'description': 'Number of Emergency Department contacts for COPD in the 6 months post MISSION'}, {'measure': 'Number of out of hour (OOH) attendances/contacts for COPD', 'timeFrame': '6 month previous', 'description': 'Number of out of hour attendances (OOH) contacts for COPD in the 6 months pre MISSION'}, {'measure': 'Number of out of hour (OOH) attendances/contacts for COPD', 'timeFrame': '6 months', 'description': 'Number of out of hour attendances (OOH) contacts for COPD in the 6 months post MISSION'}, {'measure': 'Global initiative in chronic Obstructive Lung Disease (GOLD) score', 'timeFrame': 'Baseline', 'description': 'To assess the severity of COPD by GOLD and BTS stage in the MISSION clinics'}, {'measure': 'Measurement and variation of lung function.', 'timeFrame': 'Baseline'}, {'measure': 'Assessment of eosinophilic airways inflammation', 'timeFrame': 'Baseline', 'description': 'Assessment of eosinophilic airways inflammation by Fractional Exhaled Nitric Oxide (FeNO) Assessment.'}, {'measure': 'COPD controller medication', 'timeFrame': '6 months previous', 'description': 'COPD controller medication in 6 months pre MISSION.'}, {'measure': 'COPD controller medication', 'timeFrame': '6 months', 'description': 'COPD controller medication in 6 months post MISSION.'}, {'measure': 'Number of antibiotic courses without prednisolone for lower respiratory tract infections', 'timeFrame': '6 months previous', 'description': 'Number of antibiotic courses without prednisolone for lower respiratory tract infections in 6 months pre MISSION'}, {'measure': 'Number of antibiotic courses without prednisolone for lower respiratory tract infections', 'timeFrame': '6 months', 'description': 'Number of antibiotic courses without prednisolone for lower respiratory tract infections in 6 months post MISSION'}, {'measure': 'Short acting bronchodilator (SABA) use', 'timeFrame': '6 months previous', 'description': 'Short acting bronchodilator (SABA) use measured by number of inhalers prescribed in 6 months pre MISSION.'}, {'measure': 'Short acting bronchodilator (SABA) use', 'timeFrame': '6 months', 'description': 'Short acting bronchodilator (SABA) use measured by number of inhalers prescribed in 6 months post MISSION.'}, {'measure': 'Frequency and severity of co-morbidities', 'timeFrame': 'Baseline', 'description': 'Frequency and severity of co morbidities including anxiety and depression, dysfunctional breathing, gastro oesophageal reflux and obstructive sleep apnoea in all patients.'}, {'measure': 'Medication adherence', 'timeFrame': 'Baseline', 'description': 'Medication adherence will be measured at baseline'}, {'measure': 'Medication adherence', 'timeFrame': '3 months', 'description': 'Medication adherence will be measured at 3 months'}, {'measure': 'Medication adherence', 'timeFrame': '6 months', 'description': 'Medication adherence will be measured at 6 months'}, {'measure': 'Patient activation measure', 'timeFrame': 'Baseline', 'description': 'Patients will complete the patient activation measure questionnaire at Baseline'}, {'measure': 'Patient activation measure', 'timeFrame': '3 months', 'description': 'Patients will complete the patient activation measure questionnaire at 3 months'}, {'measure': 'Patient activation measure', 'timeFrame': '6 months', 'description': 'Patients will complete the patient activation measure questionnaire at 6 months'}, {'measure': 'Investigations performed', 'timeFrame': 'Baseline', 'description': 'Investigations performed at the MISSION COPD clinics (e.g. sputum induction, High-Resolution Computed Tomography (HRCT) chest).'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS) score', 'timeFrame': 'Baseline', 'description': 'HADS scores at baseline for patients attending the MISSION clinics'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS) score', 'timeFrame': '6 months', 'description': 'HADS scores at 6 months for patients attending the MISSION clinics'}, {'measure': 'Gastroesophageal Reflux Disease Questionnaire (GERDQ) score', 'timeFrame': 'baseline', 'description': 'GERDQ scores at baseline for patients attending the Severe COPD Assessment Clinic (SCAC)'}, {'measure': 'Gastroesophageal Reflux Disease Questionnaire (GERDQ) score', 'timeFrame': '6 months', 'description': 'GERDQ scores at 6 months for patients attending the Severe COPD Assessment Clinic (SCAC)'}, {'measure': 'Assessment of inhaler technique and recommendations for inhaler devices.', 'timeFrame': 'Baseline'}, {'measure': 'Smoking cessation advice', 'timeFrame': 'Baseline'}, {'measure': 'The frequency of non-attendance at clinic', 'timeFrame': 'Baseline', 'description': 'The frequency of non-attendance at the MISSION clinic'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '24108523', 'type': 'BACKGROUND', 'citation': 'Kruis AL, Smidt N, Assendelft WJ, Gussekloo J, Boland MR, Rutten-van Molken M, Chavannes NH. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2013 Oct 10;(10):CD009437. doi: 10.1002/14651858.CD009437.pub2.'}, {'pmid': '25141877', 'type': 'BACKGROUND', 'citation': 'Wilkinson T, North M, Bourne SC. Reducing hospital admissions and improving the diagnosis of COPD in Southampton City: methods and results of a 12-month service improvement project. NPJ Prim Care Respir Med. 2014 Aug 21;24(0):14035. doi: 10.1038/npjpcrm.2014.35.'}], 'seeAlsoLinks': [{'url': 'https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/216139/dh_128428.pdf', 'label': 'Department of Health, 2011. An outcomes strategy for people with chronic obstructive pulmonary disease (COPD) and asthma in England'}, {'url': 'http://www.google.co.uk/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CCEQFjAAahUKEwiMnbWLlcTHAhUL6RQKHc6ZB30&url=http%3A%2F%2Fwww.apho.org.uk%2Fresource%2Fview.aspx%3FRID%3D142418&ei=JFbcVYz7GYvSU86znugH&usg=AFQjCNFAG7d96FNAi44xlQ5uWh3eRHFJmg', 'label': 'Public Health England, 2014. Portsmouth Unitary Authority Health Profile 2014'}, {'url': 'http://www.tobaccoprofiles.info/profile/tobacco-control/data', 'label': 'Public Health England, 2015. Local Tobacco Control Proflies.'}]}, 'descriptionModule': {'briefSummary': 'MISSION is a new and novel way of delivering highly specialised Chronic Obstructive Pulmonary Disease (COPD) care and has the potential to change the way COPD care across the UK is delivered as well as services for other long term health conditions. The MISSION model has been piloted in asthma which is the subject of an ongoing research study. This is the first model of this type in COPD and the current research study aims to evaluate the outcomes of the project. This will be done in several different ways. The study is a mixed methods evaluation of the new service comparing outcomes before and after the clinic using retrospective data analysis and prospective qualitative interview. The study will be conducted at Portsmouth Hospitals NHS Trust and will recruit patients who attend MISSION COPD clinics as well as staff who attended MISSION clinics in a professional capacity.', 'detailedDescription': "The purpose of the study is to evaluate in detail the clinical and health economic outcomes from the MISSION COPD project. MISSION COPD is a quality improvement project funded by the Health Foundation, Foundation with additional funding from Pfizer, to trial an innovative way of finding and assessing patients with COPD and also case finding new diagnoses of COPD.\n\nMISSION-COPD will allow swift early specialist multi-disciplinary interventions in primary care to diagnose and treat those at greatest risk, consistent with the NHS England '5-year Forward View' calling for removal of traditional primary and secondary care barriers. MISSION COPD will target COPD patients with risk factors for exacerbations and deteriorating lung function as well potential new diagnoses of COPD.\n\nThe aim of the study is to review the MISSION clinic model outcomes as well as performing qualitative interviews with patients who attended and staff who took part in the project.\n\nUp to 150 patients who attend the MISSION COPD clinic will be recruited along with approximately 20 health care professionals. The number of patients has been decided as the number that can be seen for the project in the MISSION COPD project time and budget.\n\nParticipants will be either:\n\n* Patients who attend MISSION COPD clinics - identified as having uncontrolled or potentially severe COPD or unrecognised COPD from GP records by the MISSION clinical team\n* Health care professionals who attend the clinic in a clinical capacity.\n\nRetrospective quantitative analysis of the data collected during the MISSION clinics will be analysed looking for COPD phenotypes and contributing co-morbidities. The data collected at the initial visit and 3 and 6 month follow up questionnaires will be analysed looking for improvement in COPD control and quality of life following the patients' attendance at MISSION clinics.\n\nA self completion questionnaire will be filled in after the clinic by participants in the research study to assess their views on the clinic and where they would like changes to be made. A questionnaire will also be given to health care professionals to seek their views on the clinic.\n\nQualitative interviews will be conducted with a sample of participants, willing to take part, to explore the experiences and acceptability of the participants and health care professionals. The interviews with health care professionals will explore their thoughts on MISSION and its strengths and weaknesses as well as any suggestions for improvement.\n\nThis research is important as it will provide evidence to support the use of the MISSION clinic model for patients with COPD. It will also give us more information on the patient with COPD and any medical conditions related to their COPD so we can adapt our service to meet their needs.\n\nThe telephone and group interviews will help us understand what we are doing right and what we are doing wrong with COPD care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be patients who attend MISSION COPD clinics, identified as having uncontrolled or potentially severe COPD or unrecognised COPD from GP records by the MISSION clinical team or health care professionals who attend the clinic in a clinical capacity.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria - Patients:\n\n* Male of Female, aged 18 years or above.\n* Attended the MISSION clinic as a patient.\n* Participant is willing and able to give informed consent for participation in the study.\n\nExclusion Criteria - Patients:\n\n\\- The patient is unable or unwilling to give consent\n\nInclusion criteria - Health Care Professionals\n\n* Male or Female, aged 18 or above.\n* Attended the MISSION clinic as a health care professional\n* Participant is willing and able to give informed consent for participation in the study.\n\nExclusion Criteria - Health Care Professionals\n\n\\- The health care professional is unable or unwilling to give consent'}, 'identificationModule': {'nctId': 'NCT02534766', 'acronym': 'MISSION-COPD', 'briefTitle': 'MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN COPD', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Portsmouth Hospitals NHS Trust'}, 'officialTitle': 'MISSION COPD - Modern Innovative SolutionS in Improving Outcomes iN - COPD - A Comparison of Clinical Outcomes Before and After the MISSION Clinic.', 'orgStudyIdInfo': {'id': 'PHT/2015/71'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who attended the MISSION COPD clinics', 'description': 'COPD patients who attended the MISSION COPD clinics, identified as having uncontrolled or potentially severe COPD or unrecognised COPD from GP records by the MISSION clinical team'}, {'label': 'Health Care Professionals', 'description': 'Health Care Professionals who attended the MISSION COPD clinics in a professional/ clinical capacity.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PO6 3LY', 'city': 'Portsmouth', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}], 'overallOfficials': [{'name': 'Professor Anoop J Chauhan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Portsmouth Hospitals NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Portsmouth Hospitals NHS Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}