Mobile Message Intervention for Stroke Caregivers' Psychological Support
The Effect of an Ecological Momentary Intervention for Stroke Caregivers' Psychological Support: a Pilot Feasibility Trial
1 other identifier
interventional
40
1 country
2
Brief Summary
The proposed trial aims to test the feasibility of ecological momentary intervention on stroke caregivers' psychological distress.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Oct 2019
Shorter than P25 for not_applicable stroke
2 active sites
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
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 24, 2019
CompletedFirst Posted
Study publicly available on registry
October 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedOctober 29, 2019
October 1, 2019
29 days
October 24, 2019
October 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change anxiety symptoms by Generalized Anxiety Disorder-7 (GAD-7) Scale at 4 weeks
4 weeks
Change stress levels by Perceived Stress Scale (PSS-4) at 4 weeks
4 weeks
Change caring burdens by Burden Interview-4 (ZBI-4) at 4 weeks
4 weeks
Study Arms (2)
Intervention group
ACTIVE COMPARATORreceive mobile messages supporting caregivers' psychological well-being, according to the participants' preferences in intervention group.
Control group
NO INTERVENTIONreceive general health information through a mobile message.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hong Kong PHAB Association
Hong Kong, Hong Kong
Hong Kong Stroke Association
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Professor
Study Record Dates
First Submitted
October 24, 2019
First Posted
October 29, 2019
Study Start
October 1, 2019
Primary Completion
October 30, 2019
Study Completion
January 31, 2020
Last Updated
October 29, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share