NCT05459103

Brief Summary

Background: During the COVID-19 pandemic, governments around the world adopted the practice of physical distancing, which increased the loneliness experienced by seniors and indirectly affected their quality of life and social support. Remote interaction through online social apps may be the safest and easiest way to address these problems. However, the empirical research on this issue is very limited. Objective: This study investigated the impact of a 12-week remote interaction intervention on loneliness, quality of life, and social support for seniors living in a community during the COVID-19 pandemic. Methods: This study adopted a randomized controlled trial design and was conducted in communities in central Taiwan. Participants in the intervention group received a 12-week bidirectional remote interaction intervention, while participants in the control group received a 12-week unidirectional remote interaction intervention. The study's primary assessment tools were the UCLA Loneliness Scale and the World Health Organization Quality of Life-BREF Scale (WHOQOL-BREF). The secondary assessment tool was the Inventory of Socially Supportive Behavior.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

July 12, 2022

Last Update Submit

July 12, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • UCLA Loneliness Scale (UCLA)

    The third version of UCLA compiled by Russel (1996) was used to measure "loneliness." It was translated into Chinese by Chang and Yang (1999) and included 20 questions. Each question was scored on the 4-point Likert Scale, with 1: "I never feel this way," 2: "I rarely feel this way," 3: "I sometimes feel this way," and 4: "I often feel this way." The total score ranged between 20 and 80, and the higher the score, the higher the participant's degree of loneliness.

    10-20 minutes

  • WHO Quality of Life-BREF (WHOQOL-BREF) Scale

    The questionnaire was composed of questions on QOL formulated by the World Health Organization (WHO) based on the commonality of various cultures. The Taiwanese version of WHOQOL-BREF included 28 questions, each scored on a 5-point Likert Scale. It was composed of four domains, namely, Physical health (7 questions), Psychological health (6 questions), Social relationships (4 questions), and Environment (9 questions). The score of an individual question ranged between 1 and 5, and after conversion, the total score of each domain ranged between 4 and 20. The higher the score, the higher the individual's QOL.

    10-20 minutes

Secondary Outcomes (1)

  • Inventory of Socially Supportive Behavior (ISSB) Scale

    10-20 minutes

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in the intervention group received a 12-week bidirectional remote interaction intervention.

Other: Bidirectional remote interaction intervention

Control group

EXPERIMENTAL

Participants in the control group received a 12-week unidirectional remote interaction intervention.

Other: Unidirectional remote interaction intervention

Interventions

Intervention group participants engaged in a 12-week bidirectional remote interaction. All interactions were conducted through the same group on Line. A one-hour interactive online group intervention was held every Monday to Friday from 14:30 to 15:30, for a total of 60 hours. The online interactive interventions were conducted in a structured course format, with a facilitator conducting live classes and alternating between static and dynamic classes.

Intervention group

Control group participants engaged in a 12-week unidirectional remote interaction. All interactions were conducted through the same group on Line. Research assistants posted a YouTube video on the Line group at 14:30 every day, Monday through Friday, covering art, music, senior sports, long-term care resources, travel, and food preparation.

Control group

Eligibility Criteria

Age65 Years - 88 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may not qualify if:

  • The study excluded (1) those who were unable to understand how to use Line or YouTube; (2) participants in the experimental group who did not fully participate in the 12-week intervention (at least three days of interaction per week); (3) those who were unable to understand the content of the questionnaire or cooperate with those assigned to help them fill it in; and (4) those who had a major illness or surgery such as a fracture within the last three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asia Univeraity

Taichung, WuFeng, 41354, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 14, 2022

Study Start

September 1, 2021

Primary Completion

January 30, 2022

Study Completion

June 30, 2022

Last Updated

July 14, 2022

Record last verified: 2022-07

Locations