Mobile Message Intervention for Stroke Caregivers' Psychological Support

Not Applicable

• Conditions: Psychological Distress; Stroke; Mobile Phone Use; Depressive Symptoms; Caregiver Burnout
• Interventions: Other: Ecological Momentary Intervention (EMI)

• Registration Number: NCT04143763
• Lead Sponsor: The University of Hong Kong

Brief Summary

The proposed trial aims to test the feasibility of ecological momentary intervention on stroke caregivers' psychological distress.

Detailed Description

75% of stroke caregivers report severe caregiver burdens, with 60% of stroke caregivers reporting at least one depressive symptom in Hong Kong. However, caregivers can experience difficulties in accessing and fully utilising existing services due to the varying types of care needs and its intensities amongst stroke survivors.

Ecological momentary intervention (EMI) as an innovative and personalised intervention has shown great potential in supporting psychological well-being; yet, there are no studies on using EMI for the caregivers' psychological support. The proposed trial aims to reduce stroke caregivers' psychological distress by delivering EMI through instant messaging applications to provide personalised and real-time support led by healthcare professionals.

Stroke caregivers screened by Patient Health Questionnaire-9 (PHQ-9) with scores ranging from 5 to 19 will be recruited from multiple sites including community centres, rehabilitation centres and outpatient clinics in public hospitals in Hong Kong, and individually randomised into the intervention group (n=20) or control group (n=20). The intervention group will receive the personalised instant messages for 4 weeks. The control group will receive general health information and regular messages reminding them to participate in follow-up surveys. The primary outcome will be the score of PHQ-9 at 4 weeks. Secondary outcomes will include anxiety, perceived stress, and caregiver burden.

Study Timeline

• Status Verified: 2019-10
• Study Start: 2019-10-01
• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-27
• Last Update Submitted: 2019-10-27
• Study First Posted: 2019-10-29
• Last Update Posted: 2019-10-29
• Primary Completion: 2019-10-30
• Study Completion: 2020-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Primary family caregiver of stroke survivor
• Able to read and communicate in Chinese
• Able to use mobile phone text messaging function
• PHQ-9 ranged from 5 to 19

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Exclusion Criteria

• Professional medical personnel and care assistants
• Has provided care for <1 month prior to recruitment
• Has diagnosis of psychiatric disease or is currently taking psychotropic drug
• PHQ-9 ≥ 20 (i.e., severe depressive symptom)
• Currently participating in any type of psychological support intervention

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Ecological Momentary Intervention (EMI)	receive mobile messages supporting caregivers' psychological well-being, according to the participants' preferences in intervention group.

Primary Outcome Measures

Name	Time	Method
Change depressive symptoms by Patient Health Questionnaire (PHQ-9) Scale (questionnaire) at 4 weeks	4 weeks	Patient Health Questionnaire (PHQ-9) Scale: PHQ-9 is a scale for screening depression in primary care. It consists of 9 items with 4 likert scale. Score range is from 0 to 27 (higher score = higher severity of depressive symptom).

Secondary Outcome Measures

Name	Time	Method
Change stress levels by Perceived Stress Scale (PSS-4) at 4 weeks	4 weeks	Perceived Stress Scale (PSS-4); PSS-4 is a scale for screening stress level. It consists of 4 items with 5 likert scale. Score range is from 0 to 16 (higher score = higher severity of stress).
Change caring burdens by Burden Interview-4 (ZBI-4) at 4 weeks	4 weeks	Burden Interview-4 (ZBI-4) Scale: ZBI-4 is a scale for screening carer's burdens. It consists of 4 items with 5 likert scale.; Score range is from 0 to 16 (higher score = higher severity of caring burden).
Change anxiety symptoms by Generalized Anxiety Disorder-7 (GAD-7) Scale at 4 weeks	4 weeks	Generalized Anxiety Disorder-7 (GAD-7) Scale: GAD-7 is a scale for screening anxiety in primary care. It consists of 7 items with 4 likert scale.; Score range is from 0 to 21 (higher score = higher severity of anxiety symptom).

Trial Locations

Locations (2)

Hong Kong PHAB Association; 🇭🇰 Hong Kong, Hong Kong

Hong Kong Stroke Association; 🇭🇰 Hong Kong, Hong Kong