TelemedicineNCT05636982
A Telecare-based Intervention in Reducing Stress Level of Informal Caregivers of Community-dwelling Older Adults
A study testing Telecare-based intervention program in people with Telemedicine, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The primary caregivers of older adults provide intimate and immediate support when their loved one is in urgent need. Due to the full-time commitment in a caregiving role, the caregiver may not have extra time to join the onsite community services that are available to them in the daytime. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Telemedicine
- What is being tested?
- Telecare-based intervention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Jan 2023to 31 Dec 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- people who are aged ≥18 years old
- understand and communicate in Cantonese
- provide care to the older adults aged ≥60 at least 4 hours per week for a minimum of 3 months
- smartphone user and know how to access the Internet
- commit to attend bi-weekly, 15-30mins online meetings with the program providers over the 3-month period
- willing to receive individual-specific video messages covering caregiving skills via WhatsApp
Who cannot join
- alcoholic drinkers or psychiatric drug users
- illiterate (inability to write and read)
- having psychiatric problems
- having cognitive impairment as evidenced by scoring 22 or above in Hong Kong version of Montreal Cognitive Assessment
- already participated in other telecare health or social programs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Telecare-based Intervention Programme in Supporting the Informal Caregivers of Community-dwelling Older Adults in Reducing Stress Level: Study Protocol for a Pilot Randomized Controlled Trial
The primary caregivers of older adults provide intimate and immediate support when their loved one is in urgent need. Due to the full-time commitment in a caregiving role, the caregiver may not have extra time to join the onsite community services that are available to them in the daytime. With the support of advanced technology, telecare seems to be a convenient and easily accessible channel to provide individualized caregiving advice to the caregivers. This study examines the effectiveness of a telecare-based intervention programme for caregivers.
Read the detailed description
Objectives: The primary caregivers of older adults provide intimate and immediate support when their loved one is in urgent need. Due to the full-time commitment in a caregiving role, the caregiver may not have extra time to join the onsite community services that are available to them in the daytime. With the support of advanced technology, telecare seems to be a convenient and easily accessible channel to provide individualized caregiving advice to the caregivers. This study examines the effectiveness of a telecare-based intervention programme for caregivers.
Hypothesis to be tested: To test if the research team-developed telecare-based intervention programme is effective in reducing the stress level of caregivers.
Design and subjects: This is a single-blinded, two-armed pilot randomized controlled trial. The subjects are people who are aged 18 or above, provide care to older adults aged ≥ 60 at least 4 hours per week for a minimum of 3 months, are capable to use smartphone to access the Internet, and are without psychiatric illnesses and cognitive impairment.
Interventions: The intervention group receives the telecare intervention programme designed by the research team. The caregivers receive nurse case management supported by a community health-social service team and be able to access a peer-support discussion forum. The control group receives usual community services
Primary outcome measure: Self-reported stress level; secondary outcome measures: self-efficacy, depression level, quality of life, and caregiving burden.
Data analysis: independent t-test or Mann-Whitney U test will be used to determine the group differences in outcomes measurements between pre- and post-intervention. Intention-to-treat will be employed as the primary analysis in this study. Per-protocol (PP) analysis will be adopted as the secondary analysis and performed separately.
Expected outcomes: Caregivers in the intervention group would benefit from the telecare-based programme with reduced stress level, depression level and caregiving burdens and yet enhanced self-efficacy and quality of life.
- Conditions
- Telemedicine
- Being tested
- Telecare-based intervention program
- Keywords
- telecare, older adults, informal caregivers, community
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telecare-based intervention programOther
A 3-month telecare-based intervention program
| Study group | Role | What they receive |
|---|---|---|
| Telecare-based intervention program | Experimental | This group of participants will receive a 3-month telecare-based intervention program which includes three main components: 1) online nurse case management supported by a health-social partnership team, 2) individual-specific video messages covering caregiving skills via WhatsApp, and 3) online information center and discussion forum via a password-protected, newly-developed caregiver website. Receives: Other: Telecare-based intervention program |
| Control | No intervention | The control group will receive conventional community services. The caregiver will attend five educational sessions that covers caregiving skills in the community centers on a fixed schedule. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress level
Stress level will be measured by the 14-item Chinese version of Perceived Stress Scale (PSS). It has been applied extensively to measure the degree of perceived stress for informal caregivers. The total score ranges between 0 (minimum stress perceived) and 56 (maximum stress perceived), with a higher score representing a greater perceived stress level.
Measured: 3-month
Secondary outcomes (4)
Self-efficacy
The General Self-Efficacy Scale (CGSE) will be used to assess the self-perceived ability to cope with stressful life events. The Chinese version of CGSE contains 10 items and is scored on a 4-point Likert scale ranging from 1 (not at all true) to 4 (exactly true). The total score ranges from 10 to 40, with higher scores indicating a greater belief in one's competence to deal with difficulties.
Measured: 3-month
Depression
Depression level will be measured by the Chinese version of The Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a self-reported scale that measures the presence of depressive symptoms. This 4-point scale is a 20-item instrument. The total scores ranged from 0 to 60, with higher scores indicating more depressive symptoms.
Measured: 3-month
Quality of life (general well-being of individual)
The Chinese (HK) version (SF-12v2-HK) of 12-item Short Form Health Survey version 2 will be used to assess the quality of life of the informal caregivers. The questionnaire contains 12 items involving different domains of health concepts, which include physical functioning, role limitation due to emotional problems, role limitation due to physical problems, mental health scale, general health, bodily pain, and social functioning and vitality (energy/fatigue). The scale ranged from 0 to 100, with 50 indicating the standardized norm scale.
Measured: 3-month
Caregiving burden
Caregiving burden will be measured using the Zarit Burden Interview (ZBI). It contains 22 items and is scored on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always). The total score ranges from 0 to 88, with a score of 24 or above may indicate a higher chance of developing depression.
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start20 Jan 2023
- Primary completion30 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arkers, Wong, The Hong Kong Polytechnic University
- Investigators
- Arkers Wong, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636982
- Sponsor's protocol ID
- P0038343
- Status last verified
- Feb 2024
- First submitted
- 23 Nov 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wong AKC, Bayuo J, Ng NP, Yau M, Yu KKS, Lin RSY, Su JJ, Hui V, Montayre J. Effectiveness of a Telecare-Based Intervention Program in Supporting Informal Caregivers of Community-Dwelling Older Adults in Reducing Stress Levels: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Apr 7;14:e70791. doi: 10.2196/70791.
PubMed 41945638Wong AKC, Ng NP, Hui VCC, Montayre J. Effect of a telecare-based intervention on stress levels in informal caregivers of older adults: protocol for a randomized controlled trial. Front Psychiatry. 2023 May 25;14:1167479. doi: 10.3389/fpsyt.2023.1167479. eCollection 2023.
PubMed 37377468
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Telecare-based Intervention Programme in Supporting the Informal Caregivers of Community-dwelling Older Adults in Reducing Stress Level: Study Protocol for a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05636982
- Acronym / sponsor ID
- P0038343
- Conditions
- Telemedicine
- Keywords
- telecare, older adults, informal caregivers, community
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Dec 2022 (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 primary caregivers of older adults provide intimate and immediate support when their loved one is in urgent need. Due to the full-time commitment in a caregiving role, the caregiver may not have extra time to join the onsite community services that are available to them in the daytime. With the support of advanced technology, telecare seems to be a convenient and easily accessible channel to provide individualized caregiving advice to the caregivers. This study examines the effectiveness of a telecare-based intervention programme for caregivers.
Detailed description
Objectives: The primary caregivers of older adults provide intimate and immediate support when their loved one is in urgent need. Due to the full-time commitment in a caregiving role, the caregiver may not have extra time to join the onsite community services that are available to them in the daytime. With the support of advanced technology, telecare seems to be a convenient and easily accessible channel to provide individualized caregiving advice to the caregivers. This study examines the effectiveness of a telecare-based intervention programme for caregivers.
Hypothesis to be tested: To test if the research team-developed telecare-based intervention programme is effective in reducing the stress level of caregivers.
Design and subjects: This is a single-blinded, two-armed pilot randomized controlled trial. The subjects are people who are aged 18 or above, provide care to older adults aged ≥ 60 at least 4 hours per week for a minimum of 3 months, are capable to use smartphone to access the Internet, and are without psychiatric illnesses and cognitive impairment.
Interventions: The intervention group receives the telecare intervention programme designed by the research team. The caregivers receive nurse case management supported by a community health-social service team and be able to access a peer-support discussion forum. The control group receives usual community services
Primary outcome measure: Self-reported stress level; secondary outcome measures: self-efficacy, depression level, quality of life, and caregiving burden.
Data analysis: independent t-test or Mann-Whitney U test will be used to determine the group differences in outcomes measurements between pre- and post-intervention. Intention-to-treat will be employed as the primary analysis in this study. Per-protocol (PP) analysis will be adopted as the secondary analysis and performed separately.
Expected outcomes: Caregivers in the intervention group would benefit from the telecare-based programme with reduced stress level, depression level and caregiving burdens and yet enhanced self-efficacy and quality of life.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telecare-based intervention program | Experimental | Other: Telecare-based intervention programThis group of participants will receive a 3-month telecare-based intervention program which includes three main components: 1) online nurse case management supported by a health-social partnership team, 2) individual-specific video messages covering caregiving skills via WhatsApp, and 3) online information center and discussion forum via a password-protected, newly-developed caregiver website. |
| Control | No intervention | –The control group will receive conventional community services. The caregiver will attend five educational sessions that covers caregiving skills in the community centers on a fixed schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- people who are aged ≥18 years old
- understand and communicate in Cantonese
- provide care to the older adults aged ≥60 at least 4 hours per week for a minimum of 3 months
- smartphone user and know how to access the Internet
- commit to attend bi-weekly, 15-30mins online meetings with the program providers over the 3-month period
Key exclusion criteria (5 listed)
- alcoholic drinkers or psychiatric drug users
- illiterate (inability to write and read)
- having psychiatric problems
- having cognitive impairment as evidenced by scoring 22 or above in Hong Kong version of Montreal Cognitive Assessment
- already participated in other telecare health or social programs
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 |
|---|---|---|
| Telecare-based intervention programA 3-month telecare-based intervention program | Other | Telecare-based intervention program |
Primary outcome
Stress level
Time frame: 3-month
Stress level will be measured by the 14-item Chinese version of Perceived Stress Scale (PSS). It has been applied extensively to measure the degree of perceived stress for informal caregivers. The total score ranges between 0 (minimum stress perceived) and 56 (maximum stress perceived), with a higher score representing a greater perceived stress level.
4 secondary outcomes
Self-efficacy
Time frame: 3-month
Depression
Time frame: 3-month
Quality of life (general well-being of individual)
Time frame: 3-month
Caregiving burden
Time frame: 3-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 41945638Wong AKC, Bayuo J, Ng NP, Yau M, Yu KKS, Lin RSY, Su JJ, Hui V, Montayre J. Effectiveness of a Telecare-Based Intervention Program in Supporting Informal Caregivers of Community-Dwelling Older Adults in Reducing Stress Levels: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Apr 7;14:e70791. doi: 10.2196/70791.
- Derived from this study: PubMed 37377468Wong AKC, Ng NP, Hui VCC, Montayre J. Effect of a telecare-based intervention on stress levels in informal caregivers of older adults: protocol for a randomized controlled trial. Front Psychiatry. 2023 May 25;14:1167479. doi: 10.3389/fpsyt.2023.1167479. eCollection 2023.
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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.
Arkers Wong, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telecare-based intervention program in people with Telemedicine, run by The Hong Kong Polytechnic University at 1 site 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 6 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: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress level (time frame: 3-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05636982, which also lists 2 linked publications.
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 28 Feb 2024.