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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06448221
Other study ID # 202100609B0A3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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: -

Study Design


Related Conditions & MeSH terms


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
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