Older AdultsNCT05459103
Remote Interactive Intervention for Loneliness
A study testing Bidirectional remote interaction intervention and Unidirectional remote interaction intervention in people with Older Adults, run by Yang Shang-Yu at 1 site in Taiwan.
Trial 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. 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?
- Bidirectional remote interaction intervention and Unidirectional remote interaction intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2021to 30 Jun 2022
- 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
- Participants had to satisfy several inclusion requirements. They had to (1) be seniors aged 65 years or older; (2) be able to communicate in Mandarin and Taiwanese; (3) have an MMSE score higher than 20 20 (following Chiang et al., 2010); (4) be able to use a smartphone; and (5) have no previous psychiatric diagnosis.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Remote Interactive Intervention for Loneliness, Quality of Life, and Social Support Among Seniors in Communities During the COVID-19 Pandemic: A Randomized Controlled Experiment
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.
Read more
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.
- Conditions
- Older Adults
- Being tested
- Bidirectional remote interaction intervention, Unidirectional remote interaction intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bidirectional remote interaction interventionOther
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.
Unidirectional remote interaction interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in the intervention group received a 12-week bidirectional remote interaction intervention. Receives: Other: Bidirectional remote interaction intervention |
| Control group | Experimental | Participants in the control group received a 12-week unidirectional remote interaction intervention. Receives: Other: Unidirectional remote interaction intervention |
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.
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.
Measured: 10-20 minutes
Secondary outcomes (1)
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.
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 posted14 Jul 2022
- Study start1 Sep 2021
- Primary completion30 Jan 2022
- Study completion30 Jun 2022
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
- 100 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
- NCT05459103
- Sponsor's protocol ID
- Remote interactive
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 14 Jul 2022
- 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 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Remote Interactive Intervention for Loneliness, Quality of Life, and Social Support Among Seniors in Communities During the COVID-19 Pandemic: A Randomized Controlled Experiment
- ClinicalTrials.gov ID
- NCT05459103
- Acronym / sponsor ID
- Remote interactive
- Conditions
- Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yang Shang-YuUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 14 Jul 2022 (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:
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Bidirectional remote interaction interventionParticipants in the intervention group received a 12-week bidirectional remote interaction intervention. |
| Control group | Experimental | Other: Unidirectional remote interaction interventionParticipants in the control group received a 12-week unidirectional remote interaction intervention. |
Who may qualify
- Ages
- 65 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Participants had to satisfy several inclusion requirements. They had to (1) be seniors aged 65 years or older; (2) be able to communicate in Mandarin and Taiwanese; (3) have an MMSE score higher than 20 20 (following Chiang et al., 2010); (4) be able to use a smartphone; and (5) have no previous psychiatric diagnosis.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Bidirectional remote interaction interventionIntervention 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. | Other | Intervention group |
| Unidirectional remote interaction interventionControl 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. | Other | Control 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.
WHO Quality of Life-BREF (WHOQOL-BREF) Scale
Time frame: 10-20 minutes
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.
1 secondary outcome
Inventory of Socially Supportive Behavior (ISSB) 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 14 Jul 2022.
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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 Bidirectional remote interaction intervention and Unidirectional remote interaction intervention 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 1 inclusion and 1 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 14 Jul 2022. 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). The study lists 2 primary outcomes in all. 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 14 Jul 2022.