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Completed

NCT Number: NCT06195969

Instant Message-guided Hypertension Management Intervention Among Stroke Survivors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong PHAB Association, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

automated instant message-guided hypertension management intervention group

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Self-efficacy (Stroke Self-Efficacy Questionnaire)

    Time frame: 4 weeks

    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.

  2. Quality of life (EuroQol 5-dimension 5-level questionnaire)

    Time frame: 4 weeks

    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.

  3. Feedback on Instant Message-Guided Hypertension Management Intervention

    Time frame: 4 weeks

    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. Self-care of high blood pressure (SC-HI)

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 8, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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