Mobile Message Intervention for Stroke Caregivers' Psychological Support

Stroke Clinical Trial

Official title:

The Effect of an Ecological Momentary Intervention for Stroke Caregivers' Psychological Support: a Pilot Feasibility Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04143763
• Other study ID #: HKUSON_LEE1
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: October 2019
• Source: The University of Hong Kong
• Contact: Jung Jae LEE, PhD
• Phone: 85239176971
• Email: leejay[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 31, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Burnout, Psychological
• Caregiver Burnout
• Depression
• Depressive Symptoms
• Mobile Phone Use
• Psychological Distress
• Stroke

Intervention

Other:
• Ecological Momentary Intervention (EMI)
Using the messaging function of mobile devices, EMI offers a framework to deliver health information to the target population, corresponding to each individual's demands in terms of type (e.g., photo, text and/or voice message), timing, duration, and frequency of the messages, which are different to the features from other interventions

Locations

Country	Name	City	State
Hong Kong	Hong Kong PHAB Association	Hong Kong
Hong Kong	Hong Kong Stroke Association	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change depressive symptoms by Patient Health Questionnaire (PHQ-9) Scale (questionnaire) at 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).	4 weeks
Secondary	Change anxiety symptoms by Generalized Anxiety Disorder-7 (GAD-7) Scale at 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).	4 weeks
Secondary	Change stress levels by Perceived Stress Scale (PSS-4) at 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).	4 weeks
Secondary	Change caring burdens by Burden Interview-4 (ZBI-4) at 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).	4 weeks