Instant Message-guided Hypertension Management Intervention Among Stroke Survivors

Stroke Clinical Trial

Official title:

Automated Instant Message-guided Hypertension Management Intervention Among Stroke Survivors: a Pilot Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06195969
• Other study ID #: HTN2023
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: April 2024

Study information

• Verified date: November 2023
• Source: The University of Hong Kong
• Contact: Jung Jae Lee
• Phone: 3917 6971
• Email: leejay[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

1. 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).

2. 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=29ac1219-3d 68-4378-a2bd-09e111da3650), which is open to the public.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Currently receiving active stroke care in acute or post-acute inpatient settings

• Has diagnosis of psychiatric disease or is currently taking psychotropic drug

Related Conditions & MeSH terms

• Hypertension
• Stroke

Intervention

Behavioral:
• automated instant message-guided hypertension management 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

Locations

Country	Name	City	State
Hong Kong	Hong Kong PHAB Association	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Shatin Hospital	Hong Kong
Hong Kong	Southern District Elderly Community Centre	Hong Kong
Hong Kong	The Hong Kong Society for Rehabilitation	Hong Kong
Hong Kong	Tung Wah Hospital	Hong Kong
Hong Kong	United Christian Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Primary	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.	4 weeks
Secondary	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.	4 weeks
Secondary	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.	4 weeks
Secondary	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.	4 weeks
Secondary	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.	4 weeks