NCT05007600

Brief Summary

Background: The early stage of the COVID-19 pandemic can be marked as a critical period in human history as it increased loneliness in people's lives. This is particularly true for the older adults who are single, living alone, and suffering from chronic diseases. However, there is insufficient existing research on associated interventions and their effectiveness. Objectives: To investigate the effectiveness of an 8-week online interactive course on the loneliness, depression, social support, and quality of life (QOL) of older adults in the community during the COVID-19 pandemic. Methods: This pilot study, also a single-blind randomized controlled trial, collected data from a community in central Taiwan. Participants were randomly divided into an experimental group and a control group. Subsequently, participants in the experimental group received an 8-week intensive (Monday to Friday) online interactive course, whereas those in the control group consumed 8 weeks of unidirectional online video and audio programs (such as from YouTube). Assessments were conducted both before and after the intervention, with the primary outcome being the UCLA Loneliness Scale (UCLA), and secondary outcomes being the Geriatric Depression Scale Short Form, the Inventory of Socially Supportive Behavior (ISSB) Scale, and the WHO Quality of Life-BREF (WHOQOL-BREF) Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 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

February 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

5 months

First QC Date

August 5, 2021

Last Update Submit

August 12, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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. In this study, the Cronbach's alpha of the pre- and post-intervention UCLA was 0.76 and 0.78, respectively.

    10-20 minutes

Secondary Outcomes (3)

  • Geriatric Depression Scale Short Form (GDS-SF)

    10-20 minutes

  • Inventory of Socially Supportive Behavior (ISSB) Scale

    10-20 minutes

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

    10-20 minutes

Study Arms (2)

trial group

EXPERIMENTAL

Participants in the experimental group received an 8-week intensive (Monday to Friday) online interactive course.

Other: Online Interactive Courses

Control group

NO INTERVENTION

Participants in the control group consumed 8 weeks of unidirectional online video and audio programs (such as from YouTube).

Interventions

In the experimental group, after consensus was reached in the expert meeting (consisting of a doctor specializing in occupational therapy, a doctor specializing in nursing, and a doctor specializing in public health), a 5-days-per-week (Monday to Friday) 8-week intensive online interactive course was designed. The course was made accessible to the participants through a social network app (Line) from 12:00 to 20:30.

trial group

Eligibility Criteria

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

You may qualify if:

  • (1) senior residents aged over 60 years, those who were not diagnosed with any cognitive impairment;
  • (2) capable of communicating in Mandarin or Taiwanese; and
  • (3) capable of using smartphones.

You may not qualify if:

  • (1) participants who could not fully complete the 8-week intervention (or participate in the course for at least three days per week); and
  • (2) those who were incapable of understanding the content of the questionnaire.

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

August 5, 2021

First Posted

August 16, 2021

Study Start

February 1, 2021

Primary Completion

July 1, 2021

Study Completion

July 30, 2021

Last Updated

August 16, 2021

Record last verified: 2021-08

Locations