Mobile Message Intervention for Stroke Caregivers' Psychological Support

Sponsor
The University of Hong Kong (Other)
Overall Status
Unknown status
CT.gov ID
NCT04143763
Collaborator
(none)
40
2
2
4
20
5

Study Details

Study Description

Brief Summary

The proposed trial aims to test the feasibility of ecological momentary intervention on stroke caregivers' psychological distress.

Condition or Disease Intervention/Treatment Phase
  • Other: Ecological Momentary Intervention (EMI)
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
The Effect of an Ecological Momentary Intervention for Stroke Caregivers' Psychological Support: a Pilot Feasibility Trial
Actual Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Oct 30, 2019
Anticipated Study Completion Date :
Jan 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intervention group

receive mobile messages supporting caregivers' psychological well-being, according to the participants' preferences in intervention group.

Other: 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

No Intervention: Control group

receive general health information through a mobile message.

Outcome Measures

Primary Outcome Measures

  1. Change depressive symptoms by Patient Health Questionnaire (PHQ-9) Scale (questionnaire) at 4 weeks [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

  1. Change anxiety symptoms by Generalized Anxiety Disorder-7 (GAD-7) Scale at 4 weeks [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).

  2. Change stress levels by Perceived Stress Scale (PSS-4) at 4 weeks [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).

  3. Change caring burdens by Burden Interview-4 (ZBI-4) at 4 weeks [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hong Kong PHAB Association Hong Kong Hong Kong
2 Hong Kong Stroke Association Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Jung-Jae Lee, Research Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04143763
Other Study ID Numbers:
  • HKUSON_LEE1
First Posted:
Oct 29, 2019
Last Update Posted:
Oct 29, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 29, 2019