Older AdultsNCT05007600
Online Interactive Courses on Loneliness and Quality of Life of Older Adults
A study testing Online Interactive Courses in people with Older Adults, run by Yang Shang-Yu at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults
- What is being tested?
- Online Interactive Courses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2021to 30 Jul 2021
- 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 65 to 88 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effectiveness of Online Interactive Courses on Loneliness and Quality of Life of Older Adults in the Community During COVID-19 Pandemic: A Pilot Study and a Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Older Adults
- Being tested
- Online Interactive Courses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Interactive CoursesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| trial group | Experimental | Participants in the experimental group received an 8-week intensive (Monday to Friday) online interactive course. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10-20 minutes
Secondary outcomes (3)
Geriatric Depression Scale Short Form (GDS-SF)
Developed by Sheikh and Yesavage (1986), GDS-SF comprises 15 Yes or No questions, with participants scoring 1 if answering "Yes" or 0 if answering "No." The 2-point scale (Yes/No) made the questionnaire easy to complete for the participants. The threshold of the scale was 7 points, with scores larger than 7 indicating a depression status. The total score ranged between 0 and 15, and the higher the score, the higher the degree of depression. In this study, the Cronbach's alpha of the pre- and post-intervention GDS-SF was 0.81 and 0.82, respectively.
Measured: 10-20 minutes
Inventory of Socially Supportive Behavior (ISSB) Scale
Initially developed by Barrera Jr et al. (1981), ISSB was subsequently translated into Chinese and compiled into 8 questions by Ou (2013). The scale consisted of two categories, namely Emotional Support and Tangible Support. The total score of both categories represented the participant's satisfaction with social support. The scale was scored on a 5-point Likert Scale, with 1 representing "Strongly disagree," 2: "Disagree," 3: "Neutral," 4: "Agree," and 5: "Strongly agree." The total score ranged between 8 and 40, and the higher the score, the higher the participant's satisfaction with social support. In this study, the Cronbach's alpha of the pre- and post-intervention ISSB was 0.83 and 0.77, respectively.
Measured: 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. In this study, the Cronbach's alpha of the domains Physical health, Psychological health, Social relationships, and Environment before and after the intervention was 0.82 (0.80), 0.77 (0.79), 0.76 (0.81), and 0.82 (0.84), respectively.
Measured: 10-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Feb 2021
- Primary completion1 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yang Shang-Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yang Shang-Yu, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007600
- Sponsor's protocol ID
- CRREC-109-088
- Status last verified
- Aug 2021
- First submitted
- 5 Aug 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effectiveness of Online Interactive Courses on Loneliness and Quality of Life of Older Adults in the Community During COVID-19 Pandemic: A Pilot Study and a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05007600
- Acronym / sponsor ID
- CRREC-109-088
- Conditions
- Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Yang Shang-YuUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 16 Aug 2021 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trial group | Experimental | Other: Online Interactive CoursesParticipants in the experimental group received an 8-week intensive (Monday to Friday) online interactive course. |
| Control group | No intervention | –Participants in the control group consumed 8 weeks of unidirectional online video and audio programs (such as from YouTube). |
Who may qualify
- Ages
- 65 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- (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.
Key exclusion criteria (2 listed)
- (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.
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 |
|---|---|---|
| Online Interactive CoursesIn 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. | Other | trial group |
Primary outcome
UCLA Loneliness Scale (UCLA)
Time frame: 10-20 minutes
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.
3 secondary outcomes
Geriatric Depression Scale Short Form (GDS-SF)
Time frame: 10-20 minutes
Inventory of Socially Supportive Behavior (ISSB) Scale
Time frame: 10-20 minutes
WHO Quality of Life-BREF (WHOQOL-BREF) Scale
Time frame: 10-20 minutes
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 16 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Interactive Courses in people with Older Adults, run by Yang Shang-Yu at 1 site in Taiwan.
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 3 inclusion and 2 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 16 Aug 2021. 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 Taiwan. 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?
UCLA Loneliness Scale (UCLA) (time frame: 10-20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2021.