Clinical trial NCT06195969: Instant Message-guided Hypertension Management Intervention Among Stroke Survivors
Official title: Automated Instant Message-guided Hypertension Management Intervention Among Stroke Survivors: a Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hypertension
Lifestyle Modifications
Keywords: Stroke
Hypertension Management
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic blood pressure
timeFrame: 4 weeks
measure: Diastolic blood pressure Diastolic blood pressure
timeFrame: 4 weeks
Secondary outcomes:
measure: Self-efficacy (Stroke Self-Efficacy Questionnaire)
timeFrame: 4 weeks
measure: Quality of life (EuroQol 5-dimension 5-level questionnaire)
timeFrame: 4 weeks
measure: Feedback on Instant Message-Guided Hypertension Management Intervention
timeFrame: 4 weeks
measure: Self-care of high blood pressure (SC-HI)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong PHAB Association
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: Shatin Hospital
city: Hong Kong
country: Hong Kong
facility: Southern District Elderly Community Centre
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Society for Rehabilitation
city: Hong Kong
country: Hong Kong
facility: Tung Wah Hospital
city: Hong Kong
country: Hong Kong
facility: United Christian Hospital
Study officials:
affiliation: School of nursing, the University of Hong Kong
name: Jung Jae Lee
role: PRINCIPAL_INVESTIGATOR
References: