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A Telecare-based Intervention in Reducing Stress Level of Informal Caregivers of Community-dwelling Older Adults

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05636982
Enrollment
75
Registered
2022-12-05
Start date
2023-01-20
Completion date
2023-12-31
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Telemedicine

Keywords

telecare, older adults, informal caregivers, community

Brief 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. 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.

Interventions

OTHERTelecare-based intervention program

A 3-month telecare-based intervention program

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Stress level3-monthStress 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.

Secondary

MeasureTime frameDescription
Self-efficacy3-monthThe 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.
Depression3-monthDepression 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.
Quality of life (general well-being of individual)3-monthThe 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.
Caregiving burden3-monthCaregiving 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.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026