StrokeNCT04143763
Mobile Message Intervention for Stroke Caregivers' Psychological Support
A study testing Ecological Momentary Intervention (EMI) in people with Stroke and Caregiver Burnout, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
The proposed trial aims to test the feasibility of ecological momentary intervention on stroke caregivers' psychological distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Caregiver Burnout, Mobile Phone Use
- What is being tested?
- Ecological Momentary Intervention (EMI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Oct 2019to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites, 2 recruiting
- Recruiting
Hong Kong PHAB Association
Hong Kong
ADMIN ADMIN, 26511468, jcfc@hkphab.org.hk
- Recruiting
Hong Kong Stroke Association
Hong Kong
Admin Admin, 23078257, hk_stroke_a@yahoo.com
About this study
Official title: The Effect of an Ecological Momentary Intervention for Stroke Caregivers' Psychological Support: a Pilot Feasibility Trial
The proposed trial aims to test the feasibility of ecological momentary intervention on stroke caregivers' psychological distress.
Read the 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.
- Being tested
- Ecological Momentary Intervention (EMI)
- Medical subject headings
- Stroke, Caregiver Burden, Cell Phone Use, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological Momentary Intervention (EMI)Other
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | receive mobile messages supporting caregivers' psychological well-being, according to the participants' preferences in intervention group. Receives: Other: Ecological Momentary Intervention (EMI) |
| Control group | No intervention | receive general health information through a mobile message. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
Secondary outcomes (3)
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).
Measured: 4 weeks
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).
Measured: 4 weeks
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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start1 Oct 2019
- Primary completion30 Oct 2019 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jung-Jae Lee, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143763
- Sponsor's protocol ID
- HKUSON_LEE1
- Status last verified
- Oct 2019
- First submitted
- 24 Oct 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Ecological Momentary Intervention for Stroke Caregivers' Psychological Support: a Pilot Feasibility Trial
- ClinicalTrials.gov ID
- NCT04143763
- Acronym / sponsor ID
- HKUSON_LEE1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: Ecological Momentary Intervention (EMI)receive mobile messages supporting caregivers' psychological well-being, according to the participants' preferences in intervention group. |
| Control group | No intervention | –receive general health information through a mobile message. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Intervention group |
Primary outcome
Change depressive symptoms by Patient Health Questionnaire (PHQ-9) Scale (questionnaire) at 4 weeks
Time frame: 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).
3 secondary outcomes
Change anxiety symptoms by Generalized Anxiety Disorder-7 (GAD-7) Scale at 4 weeks
Time frame: 4 weeks
Change stress levels by Perceived Stress Scale (PSS-4) at 4 weeks
Time frame: 4 weeks
Change caring burdens by Burden Interview-4 (ZBI-4) at 4 weeks
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecological Momentary Intervention (EMI) in people with Stroke and Caregiver Burnout, run by The University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung Jae LEE, PhD (85239176971, leejay@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change depressive symptoms by Patient Health Questionnaire (PHQ-9) Scale (questionnaire) at 4 weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019; AzTrials last refreshed its copy on 26 Oct 2026.