Clinical trial NCT05636982: A Telecare-based Intervention in Reducing Stress Level of Informal Caregivers of Community-dwelling Older Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Keywords: telecare
older adults
informal caregivers
community
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stress level
timeFrame: 3-month
Secondary outcomes:
measure: Self-efficacy
timeFrame: 3-month
measure: Depression
timeFrame: 3-month
measure: Quality of life (general well-being of individual)
timeFrame: 3-month
measure: Caregiving burden
timeFrame: 3-month
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Salvation Army
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Arkers Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: