Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-21 @ 11:33 AM
Study NCT ID:
NCT02682095
Status:
TERMINATED
Last Update Posted:
2021-03-09
First Post:
2016-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Achieve Blood Pressure Control With Retained Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Only part three, the individual interviews, has been carried out. We have not been able to get funding to complete the rest of the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-05', 'studyFirstSubmitDate': '2016-02-08', 'studyFirstSubmitQcDate': '2016-02-10', 'lastUpdatePostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-care agency', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Exercise of Self Care Agency (ESCA) instrument'}, {'measure': 'Quality of life: SF-36', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Short Form Health Survey, 36 items'}, {'measure': 'Individual interviews', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Semistructured interviews'}, {'measure': 'Focus-group interviews', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Discussions in focus-groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Blood Pressure Control', 'Adherence', 'Mixed Methods'], 'conditions': ['Hypertension', 'Patient Compliance']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to get an understanding about what problems patients with hypertension are facing, how they manage these challenges, how they feel and what requirements they believe are important to have in their treatment. These factors will later act as a foundation and incentive for designing an intervention that may result in more patients achieving blood pressure control with maintained quality of life.', 'detailedDescription': 'This is a Swedish observational mixed-methods study to get an understanding about what problems patients with hypertension are facing. The information will act as a foundation for designing an intervention/interventions that may result in more patients achieving blood pressure control with maintained quality of life. Patients, who have well/not well controlled blood pressure, are to fill in questionnaires about their view on ability to perform self-care and their perceived quality of life. Individual interviews will also be made about for what reasons they do or do not change lifestyle as well as take their drugs to treat their hypertension. In focus group interviews the patients are to be asked about what they want and expect in the encounter with health care personnel, what other things outside the health care area would be helpful for the patient and how age, gender, cultural and psychosocial aspects affect the ability to achieve blood pressure control. The developed future interventions will be evaluated in clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'To preserve that the population is representative for an area in southern Sweden, patients are to be included consequtively through stratified sampling regarding age, gender and treatment at health centre or medical clinic at a hospital as well as geographically.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with hypertension since 9 months\n* being able to read and speak Swedish\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02682095', 'briefTitle': 'To Achieve Blood Pressure Control With Retained Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Possibilities for Patients With Elevated Blood Pressure to Achieve Blood Pressure Control Without Affecting Quality of Life (the PEQ Study)', 'orgStudyIdInfo': {'id': 'The PEQ-study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients: achieved BP control', 'description': 'Patients who have achieved blood pressure control (≤140/90 mmHg)'}, {'label': 'Patients: not achieved BP control', 'description': 'Patients who have not achieved blood pressure control (\\>140/90 mmHg)'}, {'label': 'Individual interviews', 'description': 'Hypertensive patients who have considered changing lifestyle regarding one or more of the areas of tobacco, alcohol, diet, physical activity or stress.'}, {'label': 'Focus-group interviews', 'description': 'Hypertensive patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-221 00', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Department of Health Sciences', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Lena-Karin Erlandsson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eva Drevenhorn', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer', 'investigatorFullName': 'Eva Drevenhorn', 'investigatorAffiliation': 'Lund University'}}}}