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- Klinische proef NCT04143763
Mobile Message Intervention for Stroke Caregivers' Psychological Support
The Effect of an Ecological Momentary Intervention for Stroke Caregivers' Psychological Support: a Pilot Feasibility Trial
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Hong Kong, Hongkong
- Werving
- Hong Kong PHAB Association
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Contact:
- ADMIN ADMIN
- Telefoonnummer: 26511468
- E-mail: jcfc@hkphab.org.hk
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Hong Kong, Hongkong
- Werving
- Hong Kong Stroke Association
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Contact:
- Admin Admin
- Telefoonnummer: 23078257
- E-mail: hk_stroke_a@yahoo.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Intervention group
receive mobile messages supporting caregivers' psychological well-being, according to the participants' preferences in intervention group.
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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
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Geen tussenkomst: Control group
receive general health information through a mobile message.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change depressive symptoms by Patient Health Questionnaire (PHQ-9) Scale (questionnaire) at 4 weeks
Tijdsspanne: 4 weeks
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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).
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4 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change anxiety symptoms by Generalized Anxiety Disorder-7 (GAD-7) Scale at 4 weeks
Tijdsspanne: 4 weeks
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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
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Change stress levels by Perceived Stress Scale (PSS-4) at 4 weeks
Tijdsspanne: 4 weeks
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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).
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4 weeks
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Change caring burdens by Burden Interview-4 (ZBI-4) at 4 weeks
Tijdsspanne: 4 weeks
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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
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HKUSON_LEE1
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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