NCT06195969

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2024

Completed
Last Updated

July 11, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

December 8, 2023

Last Update Submit

July 10, 2024

Conditions

Keywords

StrokeHypertension Management

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Self-efficacy (Stroke Self-Efficacy Questionnaire)

    4 weeks

  • Quality of life (EuroQol 5-dimension 5-level questionnaire)

    4 weeks

  • Feedback on Instant Message-Guided Hypertension Management Intervention

    4 weeks

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

    4 weeks

Study Arms (2)

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.

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.

Interventions

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

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Currently receiving active stroke care in acute or post-acute inpatient settings
  • Has diagnosis of psychiatric disease or is currently taking psychotropic drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hong Kong PHAB Association

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Shatin Hospital

Hong Kong, Hong Kong

Location

Southern District Elderly Community Centre

Hong Kong, Hong Kong

Location

The Hong Kong Society for Rehabilitation

Hong Kong, Hong Kong

Location

Tung Wah Hospital

Hong Kong, Hong Kong

Location

United Christian Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

StrokeHypertension

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jung Jae Lee

    School of nursing, the University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2023

First Posted

January 8, 2024

Study Start

November 13, 2023

Primary Completion

January 12, 2024

Study Completion

January 12, 2024

Last Updated

July 11, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations