Mobile Message Intervention for Stroke Caregivers' Psychological Support
Primary Purpose
Stroke, Caregiver Burnout, Mobile Phone Use
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Ecological Momentary Intervention (EMI)
Sponsored by
About this trial
This is an interventional other trial for Stroke
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
Sites / Locations
- Hong Kong PHAB AssociationRecruiting
- Hong Kong Stroke AssociationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention group
Control group
Arm Description
receive mobile messages supporting caregivers' psychological well-being, according to the participants' preferences in intervention group.
receive general health information through a mobile message.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
Full Information
NCT ID
NCT04143763
First Posted
October 24, 2019
Last Updated
October 27, 2019
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04143763
Brief Title
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Anticipated)
Study Completion Date
January 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Caregiver Burnout, Mobile Phone Use, Depressive Symptoms, Psychological Distress
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
receive mobile messages supporting caregivers' psychological well-being, according to the participants' preferences in intervention group.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
receive general health information through a mobile message.
Intervention Type
Other
Intervention Name(s)
Ecological Momentary Intervention (EMI)
Intervention Description
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
Primary Outcome Measure Information:
Title
Change depressive symptoms by Patient Health Questionnaire (PHQ-9) Scale (questionnaire) at 4 weeks
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change anxiety symptoms by Generalized Anxiety Disorder-7 (GAD-7) Scale at 4 weeks
Description
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).
Time Frame
4 weeks
Title
Change stress levels by Perceived Stress Scale (PSS-4) at 4 weeks
Description
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).
Time Frame
4 weeks
Title
Change caring burdens by Burden Interview-4 (ZBI-4) at 4 weeks
Description
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).
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung Jae LEE, PhD
Phone
85239176971
Email
leejay@hku.hk
Facility Information:
Facility Name
Hong Kong PHAB Association
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ADMIN ADMIN
Phone
26511468
Email
jcfc@hkphab.org.hk
Facility Name
Hong Kong Stroke Association
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Admin Admin
Phone
23078257
Email
hk_stroke_a@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mobile Message Intervention for Stroke Caregivers' Psychological Support
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