Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-11 @ 2:34 AM
Study NCT ID:
NCT02336412
Status:
COMPLETED
Last Update Posted:
2016-02-01
First Post:
2015-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Message Service (SMS) Reminders for Stroke Secondary Preventative Medications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-29', 'studyFirstSubmitDate': '2015-01-08', 'studyFirstSubmitQcDate': '2015-01-08', 'lastUpdatePostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence rate to stroke secondary preventative medication', 'timeFrame': '3 months', 'description': 'Morisky Medication Adherence Scale (MMAS) - 8 items'}], 'secondaryOutcomes': [{'measure': 'Effect of medication adherence on clinical outcomes', 'timeFrame': '3 months', 'description': 'Number of participants reaching target blood pressure level'}, {'measure': 'Effect of medication adherence on clinical outcomes', 'timeFrame': '3 months', 'description': 'Number of participants reaching target cholesterol level'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Medication adherence'], 'conditions': ['Stroke', 'Ischemic Attack, Transient']}, 'descriptionModule': {'briefSummary': 'Secondary preventative medications are prescribed to reduce the risk of recurrent stroke following ischaemic stroke. However, continuation rates can be as low as 50% and are likely to be multifactorial. One factor will be patients forgetting to take the medication or a reduced appreciation of the importance of the medication as the time from the stroke passes. Numerous approaches to improve persistence to secondary preventative medications have been tried. One simple approach is use of mobile phone text messages as a reminder for patients to take their medications. In this study, we will introduce an educational and motivational strategy to inform patients about their medications and explore whether a reminder intervention, using Short Message Service (SMS), improves adherence to antiplatelet drugs, antihypertensive medications and lipid lowering drugs. We will also explore whether this improves blood pressure and cholesterol levels in the first 3 months after stroke.', 'detailedDescription': 'We aim to recruit adult patients diagnosed with stroke or transient ischaemic attack (TIA) who were prescribed secondary preventative medication and are living in the community. They will be provided with a patient information sheet (PIS) with details on the study and will be contacted later to ask if they wish to take part. If so, an arrangement will be made for them to attend a clinic review where they will sign the consent form. Immediately then participants who consent will be randomized into control (will receive education and motivation interviews but not text messages to remind them) or intervention (will receive education and motivation interviews and will be sent a daily text message to remind them of taking their medication). Baseline assessment will include medical history and medications prescribed. They will be given detailed information on their specific prescribed medication and will be handed booklets with relevant information. They will be asked to answer a medication adherence questionnaire and will be given a medication diary to fill in at home. All participants will receive ambulatory blood pressure monitoring.\n\nCholesterol measurement will be made using a finger prick monitor. Participants in the intervention group will be informed that they will receive a daily text message in the morning to remind them about their medications.\n\nFollow-up visits will take place after 1 and 3 months in which the same checks will be carried out as at the baseline visit. At 1 month, the cholesterol level and ambulatory blood pressure level will be repeated. Participants will be encouraged to ask if they have any concerns regarding their medications. At the end of the second visit, participants will be asked if they are satisfied with the care they received during the visits as a quality assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with stroke or TIA\n* treated with any combination of anti-platelet, antihypertensive, and/or lipid-modifying drugs; at least one of which started over the past month\n* living in the community\n\nExclusion Criteria:\n\n* severe disability (modified Rankin Scale (mRS) ≥ 4)\n* patients unable to consent\n* patients with no facility to be reminded by SMS or voicemail message'}, 'identificationModule': {'nctId': 'NCT02336412', 'briefTitle': 'Short Message Service (SMS) Reminders for Stroke Secondary Preventative Medications', 'organization': {'class': 'OTHER', 'fullName': 'NHS Greater Glasgow and Clyde'}, 'officialTitle': 'The Use of Short Message Service (SMS) as a Reminder for Continuation of Treatment With Secondary Preventative Medications After Stroke or TIA', 'orgStudyIdInfo': {'id': 'GN14NE625'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SMS reminder', 'description': 'Daily SMS medication reminder', 'interventionNames': ['Other: SMS reminder']}, {'type': 'NO_INTERVENTION', 'label': 'No SMS reminder', 'description': 'No daily SMS medication reminder'}], 'interventions': [{'name': 'SMS reminder', 'type': 'OTHER', 'description': 'Daily SMS medication reminder', 'armGroupLabels': ['SMS reminder']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G11 6NT', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Western Infirmary, NHS Greater Glasgow and Clyde', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Jesse Dawson, BSc MBChB MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Glasgow'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Glasgow', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}