CommunicationNCT06448221
Longitudinal Effectiveness of HEART Smartphone- Based Videoconferencing Program in Enhancing Residents and Family'Health
A study testing a web-based Relationship Teaching(RT)/communication education programs and Helper of Emotional Assessment Relationship Teaching (HEART) program in people with Communication and Health Behavior, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study intends to understand the longitudinal effectiveness of the smartphone- based Helper of Emotional Assessment ＆Relationship Teaching (HEART) videoconferencing program in enhancing residents and family health through the employment of a sequential-methods, triangulation research design. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication, Health Behavior
- What is being tested?
- a web-based Relationship Teaching(RT)/communication education programs and Helper of Emotional Assessment Relationship Teaching (HEART) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Nov 2021to 31 Jul 2024
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- residents were aged equal or higher than 60 years, resident's family were aged equal or higher than 20 years.
- both residents and family could communicate in Mandarin or Taiwanese
- both residents and family have no serious hearing problems
- residents has a MMSE score equal or higher than 16 for residents with no formal education or higher than 24 for residents with at least a primary school education
- both residents and family agree to participate,
- family is the significant member of residents, such as caregivers.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Longitudinal Effectiveness of Helper of Emotional Assessment and Relationship Teaching (HEART) Smartphone- Based Videoconferencing Program in Enhancing Residents and Their Family' Health
This study intends to understand the longitudinal effectiveness of the smartphone- based Helper of Emotional Assessment ＆Relationship Teaching (HEART) videoconferencing program in enhancing residents and family health through the employment of a sequential-methods, triangulation research design.
In the phase I lasing 18 months, it will employ: (a) a web-based RT/communication education programs which is develop based on understanding the experience of videoconferencing visit from family in nursing home, and (b) a HEA system which is for real-time face emotion recognition system used in videoconferencing will be developed and tested. In the phase II occupying the second 18 months it will evaluate the longitudinal effects of the HEART program on residents' and family's health change over time (baseline, 1 month, 3 months, and 6 months).
Nursing homes in Taiwan will be automated computerized blocked randomly assigned to three groups: (a) An RT group, which receives the RT program and uses 3 months' smartphone-based videoconferencing without the HEA system, (b) A HEART group, which receives the RT program and uses 3 months smartphone-based videoconferencing along with the HEA system, and(c) A control group, which has only smartphone-based videoconferencing visits.
- Conditions
- Communication, Health Behavior
- Being tested
- a web-based Relationship Teaching(RT)/communication education programs, Helper of Emotional Assessment Relationship Teaching (HEART) program
- Medical subject headings
- Communication, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a web-based Relationship Teaching(RT)/communication education programsBehavioural
receives the RT program and uses 3 months' smartphone-based videoconferencing without the HEA system.
Helper of Emotional Assessment Relationship Teaching (HEART) programBehavioural
receives the RT program and uses 3 months smartphone-based videoconferencing along with the HEA system
| Study group | Role | What they receive |
|---|---|---|
| RT group | Experimental | receives the RT program and uses 3 months' smartphone-based videoconferencing without the HEA system Receives: Behavioral: a web-based Relationship Teaching(RT)/communication education programs |
| HEART group | Experimental | receives the RT program and uses 3 months smartphone-based videoconferencing along with the HEA system Receives: Behavioral: Helper of Emotional Assessment Relationship Teaching (HEART) program |
| control group | No intervention | which has only smartphone-based videoconferencing visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
family's communication knowledge
on-line test (questionnaire scored from 0 through to 100. Higher scores mean better outcome)
Measured: baseline, 1 month, 3 months and 6 months
Secondary outcomes (4)
resident health-Geriatric Depression Scale (GDS)
scale for depression( scored from 0 through to 15.Scores of 0-4 are considered normal; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.)
Measured: baseline, 1 month, 3 months and 6 months
resident health-Activity of daily living (ADL)
assess individual's ability to perform basic self-care tasks ( (scored from 0 through to 100. higher scores mean more independence)
Measured: baseline, 1 month, 3 months and 6 months
resident health-heart rate variation (HRV)
measurement of the variation in time between each heartbeat
Measured: baseline, 1 month, 3 months and 6 months
resident health-profile of mood states(POMS)
scale for mood states.(scored from 0 through to 232. A lower score describing better mood state)
Measured: baseline, 1 month, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start12 Nov 2021
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiu Hsin Tsai, PhD, Study chair, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448221
- Sponsor's protocol ID
- 202100609B0A3
- Status last verified
- Jul 2023
- First submitted
- 24 May 2024
- Last updated
- 19 Aug 2024
- 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 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Longitudinal Effectiveness of Helper of Emotional Assessment and Relationship Teaching (HEART) Smartphone- Based Videoconferencing Program in Enhancing Residents and Their Family' Health
- ClinicalTrials.gov ID
- NCT06448221
- Acronym / sponsor ID
- 202100609B0A3
- Conditions
- Communication, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 7 Jun 2024 (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.
This study intends to understand the longitudinal effectiveness of the smartphone- based Helper of Emotional Assessment ＆Relationship Teaching (HEART) videoconferencing program in enhancing residents and family health through the employment of a sequential-methods, triangulation research design.
In the phase I lasing 18 months, it will employ: (a) a web-based RT/communication education programs which is develop based on understanding the experience of videoconferencing visit from family in nursing home, and (b) a HEA system which is for real-time face emotion recognition system used in videoconferencing will be developed and tested. In the phase II occupying the second 18 months it will evaluate the longitudinal effects of the HEART program on residents' and family's health change over time (baseline, 1 month, 3 months, and 6 months).
Nursing homes in Taiwan will be automated computerized blocked randomly assigned to three groups: (a) An RT group, which receives the RT program and uses 3 months' smartphone-based videoconferencing without the HEA system, (b) A HEART group, which receives the RT program and uses 3 months smartphone-based videoconferencing along with the HEA system, and(c) A control group, which has only smartphone-based videoconferencing visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RT group | Experimental | Behavioral: a web-based Relationship Teaching(RT)/communication education programsreceives the RT program and uses 3 months' smartphone-based videoconferencing without the HEA system |
| HEART group | Experimental | Behavioral: Helper of Emotional Assessment Relationship Teaching (HEART) programreceives the RT program and uses 3 months smartphone-based videoconferencing along with the HEA system |
| control group | No intervention | –which has only smartphone-based videoconferencing visits |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- residents were aged equal or higher than 60 years, resident's family were aged equal or higher than 20 years.
- both residents and family could communicate in Mandarin or Taiwanese
- both residents and family have no serious hearing problems
- residents has a MMSE score equal or higher than 16 for residents with no formal education or higher than 24 for residents with at least a primary school education
- both residents and family agree to participate,
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| a web-based Relationship Teaching(RT)/communication education programsreceives the RT program and uses 3 months' smartphone-based videoconferencing without the HEA system. | Behavioural | RT group |
| Helper of Emotional Assessment Relationship Teaching (HEART) programreceives the RT program and uses 3 months smartphone-based videoconferencing along with the HEA system | Behavioural | HEART group |
Primary outcome
family's communication knowledge
Time frame: baseline, 1 month, 3 months and 6 months
on-line test (questionnaire scored from 0 through to 100. Higher scores mean better outcome)
4 secondary outcomes
resident health-Geriatric Depression Scale (GDS)
Time frame: baseline, 1 month, 3 months and 6 months
resident health-Activity of daily living (ADL)
Time frame: baseline, 1 month, 3 months and 6 months
resident health-heart rate variation (HRV)
Time frame: baseline, 1 month, 3 months and 6 months
resident health-profile of mood states(POMS)
Time frame: baseline, 1 month, 3 months and 6 months
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 19 Aug 2024.
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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.
Hsiu Hsin Tsai, PhD study chair
Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a web-based Relationship Teaching(RT)/communication education programs and Helper of Emotional Assessment Relationship Teaching (HEART) program in people with Communication and Health Behavior, run by Chang Gung Memorial Hospital 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 6 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 19 Aug 2024. 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?
family's communication knowledge (time frame: baseline, 1 month, 3 months and 6 months). 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 19 Aug 2024.