StrokeNCT06195969
Instant Message-guided Hypertension Management Intervention Among Stroke Survivors
A study testing automated instant message-guided hypertension management intervention group in people with Stroke and Hypertension, run by The University of Hong Kong at 7 sites in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hypertension, Lifestyle Modifications
- What is being tested?
- automated instant message-guided hypertension management intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 7 sitesHong Kong
- Study dates
- 13 Nov 2023to 12 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stroke (ICD-10 codes: I60-I69)
- Diagnosis of hypertension and antihypertension medication
- Aged ≥18
- Able to read and communicate in Chinese (Cantonese or Putonghua)
- Able to use text messaging function on mobile phones
- MoCA 5-minute Protocol (cognitive screen) ≥14 (Equivalence to MMSE ≥ 21)
Who cannot join
- Currently receiving active stroke care in acute or post-acute inpatient settings
- Has diagnosis of psychiatric disease or is currently taking psychotropic drug
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Hong Kong7 sites
Hong Kong PHAB Association
Hong Kong
Queen Mary Hospital
Hong Kong
Shatin Hospital
Hong Kong
Southern District Elderly Community Centre
Hong Kong
The Hong Kong Society for Rehabilitation
Hong Kong
Tung Wah Hospital
Hong Kong
United Christian Hospital
Hong Kong
About this study
Official title: Automated Instant Message-guided Hypertension Management Intervention Among Stroke Survivors: a Pilot Trial
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.
Read the detailed description
Intervention group:
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.
- 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).
- Message delivery
- 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.
- 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.
Control Group:
The 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.
- Conditions
- Stroke, Hypertension, Lifestyle Modifications
- Being tested
- automated instant message-guided hypertension management intervention group
- Keywords
- Stroke, Hypertension Management
- Medical subject headings
- Stroke, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automated instant message-guided hypertension management intervention groupBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: automated instant message-guided hypertension management intervention group |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
A validated blood pressure monitor will be used to evaluate the participants' blood pressure. A higher systolic blood pressure number indicates higher blood pressure.
Measured: 4 weeks
Diastolic blood pressure Diastolic blood pressure
A validated blood pressure monitor will be used to evaluate the participants' blood pressure. A higher diastolic blood pressure number indicates higher blood pressure.
Measured: 4 weeks
Secondary outcomes (4)
Self-efficacy (Stroke Self-Efficacy Questionnaire)
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.
Measured: 4 weeks
Quality of life (EuroQol 5-dimension 5-level questionnaire)
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.
Measured: 4 weeks
Feedback on Instant Message-Guided Hypertension Management Intervention
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.
Measured: 4 weeks
Self-care of high blood pressure (SC-HI)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start13 Nov 2023
- Primary completion12 Jan 2024
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung Jae Lee, Principal investigator, School of nursing, the University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195969
- Sponsor's protocol ID
- HTN2023
- Status last verified
- Jul 2024
- First submitted
- 8 Dec 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Instant Message-guided Hypertension Management Intervention Among Stroke Survivors: a Pilot Trial
- ClinicalTrials.gov ID
- NCT06195969
- Acronym / sponsor ID
- HTN2023
- Conditions
- Stroke, Hypertension, Lifestyle Modifications
- Keywords
- Stroke, Hypertension Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intervention group:
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.
- 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).
- Message delivery
- 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.
- 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.
Control Group:
The 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: automated instant message-guided hypertension management intervention groupParticipants 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of stroke (ICD-10 codes: I60-I69)
- Diagnosis of hypertension and antihypertension medication
- Aged ≥18
- Able to read and communicate in Chinese (Cantonese or Putonghua)
- Able to use text messaging function on mobile phones
Key exclusion criteria (2 listed)
- Currently receiving active stroke care in acute or post-acute inpatient settings
- Has diagnosis of psychiatric disease or is currently taking psychotropic drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| automated instant message-guided hypertension management intervention groupParticipants 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 | Behavioural | Intervention group |
Primary outcome
Systolic blood pressure
Time frame: 4 weeks
A validated blood pressure monitor will be used to evaluate the participants' blood pressure. A higher systolic blood pressure number indicates higher blood pressure.
Diastolic blood pressure Diastolic blood pressure
Time frame: 4 weeks
A validated blood pressure monitor will be used to evaluate the participants' blood pressure. A higher diastolic blood pressure number indicates higher blood pressure.
4 secondary outcomes
Self-efficacy (Stroke Self-Efficacy Questionnaire)
Time frame: 4 weeks
Quality of life (EuroQol 5-dimension 5-level questionnaire)
Time frame: 4 weeks
Feedback on Instant Message-Guided Hypertension Management Intervention
Time frame: 4 weeks
Self-care of high blood pressure (SC-HI)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Jae Lee principal investigator
School of nursing, the University of Hong Kong
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing automated instant message-guided hypertension management intervention group in people with Stroke and Hypertension, run by The University of Hong Kong at 7 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.