NCT06448221

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2021

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

August 19, 2024

Status Verified

July 1, 2023

Enrollment Period

2.7 years

First QC Date

May 24, 2024

Last Update Submit

August 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • family's communication knowledge

    on-line test (questionnaire scored from 0 through to 100. Higher scores mean better outcome)

    baseline, 1 month, 3 months and 6 months

Secondary Outcomes (4)

  • resident health-Geriatric Depression Scale (GDS)

    baseline, 1 month, 3 months and 6 months

  • resident health-Activity of daily living (ADL)

    baseline, 1 month, 3 months and 6 months

  • resident health-heart rate variation (HRV)

    baseline, 1 month, 3 months and 6 months

  • resident health-profile of mood states(POMS)

    baseline, 1 month, 3 months and 6 months

Study Arms (3)

RT group

EXPERIMENTAL

receives the RT program and uses 3 months' smartphone-based videoconferencing without the HEA system

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

Behavioral: Helper of Emotional Assessment Relationship Teaching (HEART) program

control group

NO INTERVENTION

which has only smartphone-based videoconferencing visits

Interventions

receives the RT program and uses 3 months' smartphone-based videoconferencing without the HEA system.

RT group

receives the RT program and uses 3 months smartphone-based videoconferencing along with the HEA system

HEART group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic Mercy Hospital Attached Nursing Home

Hsinchu, Taiwan

Location

MeSH Terms

Conditions

CommunicationHealth Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Hsiu Hsin Tsai, PhD

    Chang Gung University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2024

First Posted

June 7, 2024

Study Start

November 12, 2021

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

August 19, 2024

Record last verified: 2023-07

Locations