Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:31 PM
Study NCT ID:
NCT06195969
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2023-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Instant Message-guided Hypertension Management Intervention Among Stroke Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006973', 'term': 'Hypertension'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2023-12-08', 'studyFirstSubmitQcDate': '2023-12-27', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': '4 weeks', 'description': "A validated blood pressure monitor will be used to evaluate the participants' blood pressure. A higher systolic blood pressure number indicates higher blood pressure."}, {'measure': 'Diastolic blood pressure Diastolic blood pressure', 'timeFrame': '4 weeks', 'description': "A validated blood pressure monitor will be used to evaluate the participants' blood pressure. A higher diastolic blood pressure number indicates higher blood pressure."}], 'secondaryOutcomes': [{'measure': 'Self-efficacy (Stroke Self-Efficacy Questionnaire)', 'timeFrame': '4 weeks', 'description': 'Each item was scored on an 11-point scale (0 "not at all confident" to 10 "very confident"). The total score is calculated by summing up the score of all items (range 0-130). High scores indicate greater self-efficacy.'}, {'measure': 'Quality of life (EuroQol 5-dimension 5-level questionnaire)', 'timeFrame': '4 weeks', 'description': 'The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Higher scores indicate worse quality of life.'}, {'measure': 'Feedback on Instant Message-Guided Hypertension Management Intervention', 'timeFrame': '4 weeks', 'description': 'We will conduct a broad assessment of participant feedback in this blood pressure management program, covering aspects such as the perceived value of the program. Each area will be evaluated using a 5-point Likert scale, where higher scores will consistently indicate more positive assessments across all metrics.'}, {'measure': 'Self-care of high blood pressure (SC-HI)', 'timeFrame': '4 weeks', 'description': 'The SC-HI is a 23-item measure of self-care maintenance, monitoring, and management appropriate for persons with chronic HTN. Each dimension is scored on a scale ranging from 0 to 100, with higher scores reflecting more effective self-care behavior.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Hypertension Management'], 'conditions': ['Stroke', 'Hypertension', 'Lifestyle Modifications']}, 'descriptionModule': {'briefSummary': 'This pilot and feasibility study aims to develop an automated instant message-delivered intervention (i.e., EMI) for hypertension management in stroke survivors, and to investigate the feasibility and effectiveness of the intervention.', 'detailedDescription': "Intervention group:\n\nParticipants in intervention group will receive the EMI for 4 weeks. Based on the steps of mobile message development recommended by Abroms, et al., we will develop a message content library and protocol for EMI delivery.\n\n1. Message contents: The message content library will consist of two parts: 1. brief stroke and hypertension education messages (mandatory), and 2. lifestyle modification messages (optional).\n2. Message delivery\n\n * Regular messages: The messages in the two parts will be sent regularly to each participant. As personalisation is a core process subject to behavioural changes, the content, frequency, and timing of the messages will be determined based on participants' preferences. To save labour and increase efficiency, we will develop a message 'scheduler' program. We will pre-set the message scheduler, which will then automatically send out content to participants according to their preferences. The development of the program is highly useful particularly in cases which participants prefer to receive messages during non-office hours.\n * Nurse-led real-time support messages (chat-type): Chat-based nurse support will be given to the participants as an extension of the regular messages. However, the participants will be informed beforehand that the nurse will only play a supportive role and will not provide formal care. The number of the chat messages will not be limited, but the nurse-led real-time support messages will only be provided during working hours (i.e., 9am-6pm) on weekdays to limit the nurse RA's workload.\n\nControl Group:\n\nThe control group will receive one instant message about general stroke management including hypertension management from the Hospital Authority of HK SAR Government website (https://www21.ha.org.hk/smartpatient/SPW/en-US/Disease-Information/Disease/?guid=29ac1219-3d68-4378-a2bd-09e111da3650), which is open to the public."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of stroke (ICD-10 codes: I60-I69)\n* Diagnosis of hypertension and antihypertension medication\n* Aged ≥18\n* Able to read and communicate in Chinese (Cantonese or Putonghua)\n* Able to use text messaging function on mobile phones\n* MoCA 5-minute Protocol (cognitive screen) ≥14 (Equivalence to MMSE ≥ 21)\n\nExclusion Criteria:\n\n* Currently receiving active stroke care in acute or post-acute inpatient settings\n* Has diagnosis of psychiatric disease or is currently taking psychotropic drug'}, 'identificationModule': {'nctId': 'NCT06195969', 'briefTitle': 'Instant Message-guided Hypertension Management Intervention Among Stroke Survivors', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Automated Instant Message-guided Hypertension Management Intervention Among Stroke Survivors: a Pilot Trial', 'orgStudyIdInfo': {'id': 'HTN2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Participants in intervention group will receive the EMI for 4 weeks. Based on the steps of mobile message development recommended by Abroms, et al. , we will develop a message content library and protocol for EMI delivery.', 'interventionNames': ['Behavioral: automated instant message-guided hypertension management intervention group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group will receive instant messages about general stroke management including hypertension management from the Hospital Authority of HK SAR Government website, which is open to the public (https://www21.ha.org.hk/smartpatient/SPW/en-US/Disease-Information/Disease/?guid=29ac1219-3d68-4378-a2bd-09e111da3650), with reminder text messages of importance follow-up surveys.'}], 'interventions': [{'name': 'automated instant message-guided hypertension management intervention group', 'type': 'BEHAVIORAL', 'description': 'Participants in intervention group will receive the EMI for 4 weeks. Based on the steps of mobile message development recommended by Abroms, et al., we will develop a message content library and protocol for EMI delivery', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Hong Kong PHAB Association', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Shatin Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Southern District Elderly Community Centre', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Hong Kong Society for Rehabilitation', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Tung Wah Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'United Christian Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Jung Jae Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of nursing, the University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}