Instant Message-guided Hypertension Management Intervention Among Stroke Survivors

July 10, 2024 updated by: The University of Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

  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=29ac1219-3d68-4378-a2bd-09e111da3650), which is open to the public.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Tung Wah Hospital
      • Hong Kong, Hong Kong
        • United Christian Hospital
      • Hong Kong, Hong Kong
        • Shatin Hospital
      • Hong Kong, Hong Kong
        • Hong Kong PHAB Association
      • Hong Kong, Hong Kong
        • The Hong Kong Society for Rehabilitation
      • Hong Kong, Hong Kong
        • Southern District Elderly Community Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
No Intervention: Control group
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks
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 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks
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.
4 weeks
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 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Jung Jae LEE, School of Nursing, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2023

Primary Completion (Actual)

January 12, 2024

Study Completion (Actual)

January 12, 2024

Study Registration Dates

First Submitted

December 8, 2023

First Submitted That Met QC Criteria

December 27, 2023

First Posted (Actual)

January 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTN2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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