Longitudinal Effectiveness of HEART Smartphone- Based Videoconferencing Program in Enhancing Residents and Family'Health

Health Behavior Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06448221
• Other study ID #: 202100609B0A3
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2023
• Source: Chang Gung Memorial Hospital
• Contact: Hsiu Hsin Tsai, PhD
• Phone: 032118800
• Email: kitty[@]mail.cgu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 215
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. residents were aged equal or higher than 60 years, resident's family were aged equal or higher than 20 years.

2. both residents and family could communicate in Mandarin or Taiwanese

3. both residents and family have no serious hearing problems

4. 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

5. both residents and family agree to participate,

6. family is the significant member of residents, such as caregivers. Exclusion Criteria: -

Related Conditions & MeSH terms

• Communication
• Health Behavior

Intervention

Behavioral:
• a web-based Relationship Teaching(RT)/communication education programs
receives the RT program and uses 3 months' smartphone-based videoconferencing without the HEA system.
• Helper of Emotional Assessment Relationship Teaching (HEART) program
receives the RT program and uses 3 months smartphone-based videoconferencing along with the HEA system

Locations

Country	Name	City	State
Taiwan	Catholic Mercy Hospital Attached Nursing Home	Hsinchu

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	family's communication knowledge	on-line test (questionnaire scored from 0 through to 100)	baseline, 1 month, 3 months and 6 months
Secondary	resident health-Geriatric Depression Scale (GDS)	scale for depression	baseline, 1 month, 3 months and 6 months
Secondary	resident health-Activity of daily living (ADL)	assess individual's ability to perform basic self-care tasks	baseline, 1 month, 3 months and 6 months
Secondary	resident health-heart rate variation (HRV)	measurement of the variation in time between each heartbeat	baseline, 1 month, 3 months and 6 months
Secondary	resident health-profile of mood states(POMS)	scale for mood states.	baseline, 1 month, 3 months and 6 months