Clinical trial NCT04143763: Mobile Message Intervention for Stroke Caregivers' Psychological Support
Official title: The Effect of an Ecological Momentary Intervention for Stroke Caregivers' Psychological Support: a Pilot Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Caregiver Burnout
Mobile Phone Use
Depressive Symptoms
Psychological Distress
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change depressive symptoms by Patient Health Questionnaire (PHQ-9) Scale (questionnaire) at 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Change anxiety symptoms by Generalized Anxiety Disorder-7 (GAD-7) Scale at 4 weeks
timeFrame: 4 weeks
measure: Change stress levels by Perceived Stress Scale (PSS-4) at 4 weeks
timeFrame: 4 weeks
measure: Change caring burdens by Burden Interview-4 (ZBI-4) at 4 weeks
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong PHAB Association
city: Hong Kong
country: Hong Kong
facility: Hong Kong Stroke Association
Study officials:
References: